Acute reference doses for agricultural and veterinary chemicals

Edition 2/2023, current as of 30 June 2023

Introduction

The acute reference doses for agricultural and veterinary chemicals (ARfD list) provides a tabulation of acute reference doses (ARfDs; in units of mg/kg bodyweight) for each agricultural or veterinary (agvet) chemical listed.

The ‘Date’ column indicates when particular ARfDs were established.

The 'Study' column provides information about the pivotal study, including type, the NOAEL (no-observed-adverse-effect level) and the critical toxicological endpoint. For some agvet chemicals, longer-term rather than acute dosing studies have been used to establish the ARfD. In these cases, the NOAEL was selected on the basis of toxicological effects observed after the first dose.

The ‘Comments’ column may:

  1. provide additional information about its applicability to the general population
  2. advise that an ARfD is not necessary
  3. indicate that the ARfD has been adopted from that established by the FAO/WHO Joint Meeting on Pesticide Residues (JMPR).

Contact

If you have any questions about the ARfD list, or require this content in another format, please contact:

Assistant Director, Communications
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001 Australia

Telephone: +61 2 6770 2300
Email: communications@apvma.gov.au.

Printable version

View a printable PDF or word version of the ARfD list.

ARfD list

Select a letter below to view chemicals in the ARfD list by alphabetical order.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Abamectin (sum of abamectin + 8,9–Z Isomer)

0.002

0.25

6 August 2018

Based on the overall NOAEL of 0.25 mg/kg bw per day for clinical signs in dogs (mydriasis) observed in the first week of treatment at 0.5 mg/kg bw per day.

A total uncertainty factor of 100 has been applied. The ARfD also applies to the 8,9–Z isomer of avermectin B1a and 24-hydroxymethyl abamectin.

The 24-hydroxymethyl metabolite of abamectin is regarded as having no greater toxicity than the parent molecule.

Acephate

0.1

≥ 1.2

2005

Single dose study in humans. No inhibition of erythrocyte acetylcholinesterase activity was reported in either sex at any dose. No clinically significant changes were seen in vital signs or on electrocardiography, haematology, clinical chemistry, urine analysis or physical examination. The

NOAEL was 1.2 mg/kg bw per day, the highest dose tested.

The critical toxicological effect of acephate is the inhibition of acetylcholinesterase activity in the nervous system, an effect that is dependent on Cmax rather than on the area under the curve (AUC).

Data on inhibition in vitro indicate that human brain acetylcholinesterase is slightly less sensitive to inhibition by acephate than is rat brain acetylcholinesterase. Well conducted toxicokinetics studies, available for both rats and humans, show that there is no significant difference between the two species; in particular, Cmax values have the same relationship to administered dose in the two species, and acephate is rapidly absorbed and eliminated in both species.

Data for rats in vivo indicate that inhibition of brain acetylcholinesterase activity occurs at lower doses than those required for a similar level of inhibition of erythrocyte acetylcholinesterase activity.

Data for dogs and monkeys in vivo indicate that brain and erythrocyte acetylcholinesterase activities are nearly equally inhibited at any given dose, and do not show the difference seen in rats, which might thus be rat-specific.

Well-conducted single and repeated-dose studies in humans clearly demonstrated a dose where no inhibition of blood cholinesterase activities occurred. Data from animals in vivo do not show sex differences in inhibition of acetylcholinesterase activity or clinical signs.

Since there is no interspecies extrapolation, an overall safety factor of 10 was used.

Acequinocyl 0.08 8 13 January 2021 Rat mechanistic studies; single oral dose produced effects on blood coagulation (increases in prothrombin and activated partial thromboplastin time) at higher doses.  

Acetamiprid

0.1

10

27 July 2001

Single-dose gavage neurotoxicity rat study; a NOAEL of 10 mg/kg bw was based on reductions in locomotor activity at the next higher dose.

 

Acibenzolar-S-methyl

0.01

10 [LOAEL]

23 April 2002

Developmental rat study; based on haemorrhagic discharge in dams at LOAEL of 10 mg/kg bw/d.

 

Aclonifen     24 November 2020   ARfD considered to be unnecessary due to its low acute toxicity, the lack of evidence for any acute neurotoxicity and the absence of any other toxicologically relevant effect that might be attributable to a single dose.

Afidopyropen

0.3

30

27 November 2017

Developmental rabbit studies; an overall NOAEL of 30–32 mg/kg bw/d was based on inappetence observed at the next higher dose.

ARfD for afidopyropen applies to the general population.

Aldicarb

0.001

0.01

15 December 1999

Human acute study; a NOAEL of 0.01 mg/kg bw was based on significant and dose-related RBC AChE inhibition at the next higher dose.

 

Ametoctradin

 

 

1 February 2012

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Amicarbazone

0.1

10

9 June 2006

Acute neurotoxicity study; a NOAEL of 10 mg/kg bw was based on clinical signs of neurotoxicity at the next higher dose.

 

Aminocyclopyrachlor     9 September 2022   ARfD considered to be unnecessary due to its low acute toxicity, the lack of evidence for any acute neurotoxicity and the absence of any other toxicologically relevant effect that might be attributable to a single dose.

Aminopyralid

 

 

10 January 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Amisulbrom

 

 

14 June 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Atrazine

 

 

5 December 2000

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Aureobasidium pullulans

 

 

21 February 2017

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Azafenidin

0.016

16

4 July 2001

Developmental rat study; a NOAEL of 16 mg/kg bw/d was based on increased incidence of resorptions (predominantly early) at the next higher dose.

ARfD for azafenidin only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Azimsulfuron

 

 

10 January 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Azinphos-methyl

0.075

0.75

5 December 2000

Acute human study; a NOAEL of 0.75 mg/kg bw was based on the absence of RBC ChE inhibition or clinical signs.

 

Azoxystrobin

 

 

21 April 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

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B

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Bacillus amyloliquefaciens

 

 

9 May 2002

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Bacillus licheniformis

 

 

9 May 2002

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Bacillus sphaericus strain 2362

 

 

9 May 2003

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Bacillus subtilis (see Bacillus amyloliquefaciens)

 

 

 

 

 

Bacillus thuringiensis

 

 

6 September 2002

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Bacillus thuringiensis subsp. thuringiensis serotype 1 (strain MPPL 002)

 

 

28 August 2003

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Beauveria bassiana

 

 

8 August 2017

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Bentazone

 

 

21 April 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Benzovindiflupyr

0.1

10

23 July 2018

Clinical observations, (decreased locomotor activity at 1 h post-dosing and reduced forelimb grip strength in females at 1 h post-dosing).

 

Benzylpenicillin procaine

 

 

10 October 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Bicyclopyrone

0.01

1

10 January 2017

Developmental rabbit study; a NOAEL of 1 mg/kg bw/d was based on increased incidence of urogenital malformations along with skeletal variations at the next higher dose.

ARfD for bicyclopyrone only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Bifenazate

 

 

10 January 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Bitertanol

 

 

21 April 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Bixafen

0.2

20

18 January 2016

Developmental rat study; a NOAEL of 20 mg/kg bw/d was based on reduced body weight gain in dams and foetuses at the next higher dose.

 

Bixlozone     6 April 2020   ARfD considered to be unnecessary due to its low oral toxicity and and the absence of any developmental toxicity or neurological effects after a single dose.

Boscalid

 

 

10 January 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Bromide

 

 

10 October 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Bromoxynil 0.05 5 7 May 2021 Developmental rat study; a NOAEL of 5 mg/kg bw/d was based on reduced numbers of live foetuses, foetal weight, increased late uterine deaths and decreased maternal body weight, along with microphthalmia and minor skeletal variations at maternotoxic doses. The ARfD applies to bromoxynil and its esters, expressed as bromoxynil phenol equivalents. ARfD only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Bupivacaine

 

 

17 February 2017

 

There was insufficient information to establish an ARfD, however, based on its proposed pattern of use the dietary intake is likely to be low.

Buprofezin

0.5

50

31 October 2006

Developmental rabbit study; a NOAEL of 50 mg/kg bw/d was based on bodyweight loss at the next higher dose.

 

Butafenacil

 

 

19 November 2001

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

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C

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Captan

0.1

10

18 May 2007

Developmental rabbit study; a NOAEL of 10 mg/kg bw/d was based on reduced maternal body weight and increased skeletal variations in foetuses at the next higher dose.

ARfD for captan only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Carbaryl

0.01

1

13 December 2002

Subchronic neurotoxicity rat study; a NOAEL of 1 mg/kg bw/d was based on behavioural indications of autonomic neurotoxicity and reduced brain, plasma and RBC ChE activity at the next higher dose.

 

Carbendazim

0.05

50 [LOAEL]

15 February 2011

Special acute study in male rats; based on significant testicular and efferent ductal alterations at 50 mg/kg bw, the lowest dose tested.

The ARfD is also supported by an acute in vivo genotoxicity study, with increased frequencies of micronuclei were observed in spermatids at a LOAEL of 50 mg/kg bw.

Carbetamide 0.3 30 1 October 2020 90-day and 1-year dog studies; a NOAEL of 30 mg/kg bw/d was based on the observation of clinical signs of neurotoxicity including unsteady gait, drowsiness and tremor which were manifest early in the studies and may occur after acute exposures.  

Ceftiofur (as free acids and salts)

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Cephalexin

 

 

22 November 2000

 

ARfD is considered to be unnecessary; therapeutic dose for adults ranges between 1–4 g/day.

Cetrimide

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Chlorantraniliprole

 

 

9 May 2008

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Chlorfenvinphos

0.02

1.9

5 December 2000

14-day mouse study; a NOAEL of 1.9 mg/kg bw/d was based on inhibition of RBC ChE activity at the next higher dose.

 

Chlormequat

0.07

7.5

23 June 2005

2-year dietary dog study; a NOAEL of 7.5 mg/kg bw/d was based on excessive salivation and muscle weakness observed after a single dose.

 

Chloropicrin

 

 

16 January 2014

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Chlorpyrifos

0.03

1

June 2019

Based on the no observed effect level of 1 mg/kg bw for inhibition of erythrocyte (acetyl) cholinesterase human males and incorporates a total uncertainty factor of 30.

Selected NOAEL is sufficiently protective against inhibition of brain cholinesterase and other effects of chlorpyrifos. (APVMA reconsideration of chlorpyrifos - toxicology update - June 2019)

Cinmethylin

0.3

30

20 August 2003

Developmental rat study; a NOAEL of 30 mg/kg bw/d was based on clinical signs (excess salivation and urine stained abdominal fur) at the next higher dose.

 

Clethodim

 

 

2 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Clofentezine

 

 

31 December 2019

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Clitoria ternatea

 

 

23 November 2015

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

d-Cloprostenol

 

 

21 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Cloquintocet acid

 

 

5 July 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Clothianidin

0.2

25

1 August 2003

Acute neurotoxicity mouse study; a NOAEL of 25 mg/kg bw was based on clinical signs (reduced spontaneous activity) at the next higher dose.

 

Codling Moth Granulosis Virus

 

 

25 November 2002

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Cyantraniliprole

 

 

21 January 2013

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Cyazofamid

 

 

6 June 2013

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Cyclaniliprole

 

 

29 February 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Cyflufenamid

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Cyflumetofen     31 January 2022   ARfD is considered to be unnecessary due to its low oral toxicity and the absence of any neurological effects or developmental toxicity after a single dose.
 

Cyhalofop-butyl

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

gamma-Cyhalothrin

0.005

0.5

12 August 2003

Developmental rat study; a NOAEL of 0.5 mg/kg bw/d was based on clinical signs of toxicity, reduced body weight gains and food consumption observed in dams at the next higher dose.

 

beta-Cypermethrin

0.05

4.7

19 March 2002

3-month feeding dog study; a NOAEL of 4.7 mg/kg bw/d was based on clinical signs (whole body tremors, head nodding, 'lip-licking', subduedness, ataxia, agitation and a high-stepping gait) at the next higher dose.

 

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D

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Decoquinate

 

 

4 June 2013

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Derquantel

0.01

1

27 May 2011

Acute neurotoxicity dog study; a NOAEL of 1 mg/kg bw was based on clinical signs (mydriasis, ptosis, dry eyes) at the next higher dose.

 

Dexamethasone

 

 

10 October 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Diazinon

0.01

0.2

20 December 2002

Acute dose human volunteer study; a NOAEL of 0.2 mg/kg bw was based on RBC ChE inhibition at the next higher dose.

 

2,6 dichlorobenzamide (BAM)

0.13

12.5

14 February 2023

8-day oral (gavage) toxicity study oral (gavage) toxicity study in rats; a NOAEL of 12.5 mg/kg bw was based on the occurrence of adverse clinical signs (impaired righting reflex, miosis, hypothermia, moderate analgesia and rapid but shallow breathing) at the next higher dose.

An important plant metabolite common to dichlobenil and fluopicolide. ARfD for 2,6 dichlorobenzamide (BAM) applies to the general population.

2,4-dichlorophenoxyacetic acid (2,4-D)

0.8

75

12 September 2006

Acute neurotoxicity rat study; a NOAEL of 75 mg/kg bw was based on gait/coordination effects and decreased motor activity at the next higher dose.

 

Dichlorprop-P

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Dichlorvos

0.1

1

6 April 2004

Single oral dose human volunteer study; a NOAEL of 1 mg/kg bw was based on the absence of any reduction in RBC ChE activity at 1 mg/kg bw, the only dose tested.

 

Diclazuril

 

 

7 October 2021

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any neurological effects or developmental toxicity after a single dose.

Difethialone

0.0005

0.48 [LOAEL]

17 April 2007

Acute oral rat study; a LOAEL of 0.48 mg/kg bw was based on death.

 

Diflufenican     May 2020   ARfD considered to be unnecessary due to its low oral toxicity or the absence of any developmental toxicity after a single dose

Dimethenamid-P

0.25

25

12 August 03

Developmental rat study; a NOAEL of 25 mg/kg bw/d was based on signs of toxicity in the foetus (reduced bodyweight and incomplete ossification) at the next higher dose.

ARfD for dimethenamid-P only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary. Note: Dimethenamid-P, the S-isomer, and its racemic mixture have equivalent toxicity at similar dose levels.

Dimethoate

0.02

0.2

23 November 2010

Human volunteer study; a NOAEL of 0.2 mg/kg bw/d was based on ChE inhibition in whole blood at the next higher dose.

 

Dimethomorph

 

 

17 April 2020

 

ARfD considered unnecessary due to its low oral toxicity and the absence of any neurological effects or developmental toxicity after a single dose

Dimpropyridaz     19 December 2022   ARfD considered unnecessary due to its level acute oral toxicity, lack of acute neurotoxicity, lack of effects on reproduction and development and lack or any effect that would likely occur following a single exposure event.

Dinotefuran

1.25

125

10 August 2015

Developmental rabbit study; a NOAEL of 125 mg/kg bw/d was based on reduced body weight gain at the next higher dose.

 

Diphenylamine

 

 

21 April 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose. (JMPR 1998).

Diquat

0.8

75

8 February 2018

Acute neurotoxicity rat study; a NOAEL of 75 mg/kg bw was based on clinical signs, inappetence and reduced bodyweight gain at the next higher dose.

 

Diuron

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Doramectin

0.02

1.5

14 October 2002

Developmental rabbit study; a NOAEL of 1.5 mg/kg bw/d was based on maternal toxicity with major malformations (cleft palate, phocomelia, syndactyly and coelosomia) observed in fetuses at 3 mg/kg bw/d and delayed ossification observed at 1.5 and 3 mg/kg bw/d.

ARfD for doramectin only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

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E

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Emamectin benzoate

0.03

5

11 December 2018

Based on acute neurotoxicity in rats (tremors, irritability) at 10 mg/kg bw. Neurobehavioral effects were accompanied by serious histopathological observations of neuronal degeneration in brain and spinal cord as well as effects on sciatic nerves at 25 mg/kg bw.

JMPR 2011

Uncertainty factors applied were 10 for interspecies uncertainties, 10 for intraspecies uncertainties and 2 for severity of effect due to the serious neuropathological effects at 25 mg/kg bw.

Enterococcus faecium

 

 

4 September 2002

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Epoxiconazole

0.2

20

16 April 2002

Developmental rabbit study; a NOAEL of 20 mg/kg bw/d was based on increased incidence of resorptions at the next higher dose.

ARfD for epoxiconazole only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Eprinomectin

0.2

1.5

31 January 2018

Human clinical trial; absence of any effects at the highest tested dose of 1.5 mg/kg bw.

ARfD was based on a clinical trial with ivermectin using a 'read across' approach due to the structural similarity and pharmacokinetic similarities of the two avermectin analogues.

Esfenvalerate

0.02

1.75

31 January 2018

Acute neurotoxicity rat study; a NOAEL of 1.75 mg/kg bw was based on clinical signs of neurotoxicity (tremors) at the next higher dose.

 

Ethametsulfuron-methyl

 

 

17 January 2001

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Ethoxyquin

0.5

50

21 February 2000

Acute oral (capsule) dog study; a NOAEL of 50 mg/kg bw for effects on the hepatic biliary system and clinical signs at the next higher dose.

ARfD for ethoxyquin is based on JMPR evaluation (2005). The ARfD which is applicable for the general population includes three residues (MEQ, DHMEQ and DHEQ).

Ethoxysulfuron

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Ethyl formate

 

 

26 November 2003

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Etofenprox

1

100

4 December 2017

Developmental rabbit studies; an overall NOAEL of 100 mg/kg bw/d in two studies was based on reduced maternal bodyweight and food consumption immediately after dosing and an increased incidence of post-implantation loss at the next higher dose. (JMPR 2011, EFSA 2009).

ARfD for etofenprox only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Etoxazole

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Eugenol     19 August 2020   ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

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F

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Fenamiphos

0.003

0.25

7 November 2005

Acute oral dog study; a NOAEL of 0.25 mg/kg bw was based on inhibition of RBC ChE activity at the next higher dose.

 

Fenbuconazole

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Fenhexamid

 

 

2 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Fenitrothion

0.03

0.33

5 December 2000

Acute single dose human volunteer study; a NOAEL of 0.33 mg/kg bw was based on the absence of any inhibition of plasma and RBC ChE activity at the highest tested dose.

 

Fenpyrazamine

0.8

80

15 February 2017

Acute neurotoxicity rat study; a NOAEL of 80 mg/kg bw was based on a reduction in motor activity and number of rearings at the next higher dose.

 

Fenpyroximate 0.005 0.5 13 June 2023 1-year capsule fed dog study; a NOAEL of 0.5 mg/kg bw/d was based on the occurrence of bradycardia at the next higher dose. The electrocardiographic effects of fenpyroximate may potentially occur following acute exposure.

Fipronil

0.02

2.5

19 June 2006

Two acute oral neurotoxicity rat studies; a NOAEL of 2.5 mg/kg bw was based on reduced footsplay at the next higher dose.

This is a group ARfD value which includes fipronil, desulfinyl fipronil, fipronil sulphide and fipronil sulphone.

Flazasulfuron

 

 

26 September 2011

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Flonicamid

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Florasulam

 

 

26 May 2009

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Florfenicol

 

 

4 January 2001

 

ARfD considered unnecessary due to its low oral toxicity after a single dose; structural analogs of florfenicol have a long history of therapeutic use without acute effects.

Florpyrauxifen-benzyl

 

 

8 August 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Florylpicoxamid     16 February 2022   ARfD considered to be unnecessary on the basis of its low acute toxicity, the lack of evidence for any acute neurotoxicity and the absence of any other toxicologically relevant effect that might be attributable to a single dose.
 
Fluazaindolizine 1.3 125 1 September 2022 Acute oral neurotoxicity rat study; a NOAEL of 125 mg/kg bw was based on inappetence and bodyweight loss at the next higher dose. This ARfD applies to fluazaindolizine and its metabolites namely IN-A5760, IN-F4106, IN-QEK31, IN-QZY47, IN-TMQ01, IN-UJV12 or IN-UNS90, expressed as fluazaindolizine.

Flubendiamide

 

 

14 December 2007

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Fludioxonil

 

 

2 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Fluensulfone

0.15

16.2

12 June 2014

2-Gen reproduction study; a NOAEL of 16.2 mg/kg bw/d based on post-natal loss of pups at the next higher dose.

ARfD for fluensulfone applies to the general population.

Flufenoxuron

 

 

2 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Flumethrin

 

 

4 September 2001

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Flumiclorac pentyl

 

 

8 December 2004

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Flumioxazin

0.1

10

26 February 2021

Oral rat development study; a NOAEL of 10 mg/kg bw/d based on an increased incidence of cardiovascular abnormalities at the next highest dose.

ARfD for flumioxazin only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Flunixin meglumine

0.02

2

1 August 2002

6-week rat study; a NOAEL of 2 mg/kg bw/d was based clinical signs (reduced activity) at the next higher dose.

 

Fluopyram

0.5

50

6 July 2015

Acute neurotoxicity rat study; a NOAEL of 50 mg/kg bw/d was based on slightly lower motor and locomotor activity at the next higher dose.

 

Fluopxapiprolin     23 May 2022   ARfD considered unnecessary, based on the absence of any toxic effects in laboratory animals observed after a single dose.

Flupyradifurone

0.35

35

11 August 2015

Acute neurotoxicity rat study; a NOAEL of 35 mg/kg bw was based on increased incidences of piloerection and increased incidences of pupil dilation at the next higher dose.

 

Fluralaner

 

 

31 May 2018

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

 

Flutolanil

 

 

28 August 2001

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Fluxapyroxad

 

 

20 March 2020

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Formesafen 1 100 29 March 2021 Rat acute neurotoxicity study; a NOAEL of 100 mg/kg bw/day based on potential acute neurotoxicity at the next higher dose  

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G

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Geraniol     19 August 2020   ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Glufosinate ammonium

 

 

28 August 2001

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Glyphosate

 

 

2 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

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H

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Halauxifen-methyl

 

 

17 September 2014

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Halofuginone

0.0003

0.025

16 June 2006

Developmental rabbit study; a NOAEL of 0.025 mg/kg bw/d was based on reduced body weight gain and food consumption, mortality and abortions at the next higher dose.

ARfD for halofuginone only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Halsulfuron-methyl 0.5 50 4 February 2022 Developmental rabbit study; a NOAEL of 50 mg/kg bw/d was based on increased number of resorptions (total and per dam and increased post-implantation loss) at the next higher dose. ARfD for halosulfuron-methyl only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Hexaflumuron

 

 

31 August 2001

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Hexythiazox

 

 

2 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

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I

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Imazalil

0.05

5

29 January 2007

Developmental rabbit study; a NOAEL of 0.05 mg/kg bw/d was based on increased number of resorptions and a reduced number of live pups at the next higher dose.

ARfD for imazalil only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Imazapic

 

 

2 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Imazapyr

 

 

2 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Imazethapyr

 

 

2 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Indaziflam 0.08 7.5 12 May 2023 3-month gavage dog study; a NOAEL of 7.5 mg/kg bw/d was based on degenerative lesions in the spinal cord and sciatic nerve at the next higher dose of 15 mg/kg bw/d. For dietary risk, indaziflam is the sum of indaziflam and 6-[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4-diamine (=indaziflam-triazinediamine), expressed as indaziflam.

Indoxacarb (S-Isomer) + R-Isomer

0.1

12.5

30 May 2008

Acute neurotoxicity rat study; a NOAEL of 12.5 mg/kg bw was based on reduced bodyweight gain and food consumption at the next higher dose.

 

Inpyrfluxam 0.3 30 26 May 2023 Acute neurotoxicity study in rats; a NOAEL of 30 mg/kg bw was based on reduced motor activity (no neuropathology correlates) and body temperature at the next higher dose. Inpyrfluxam is expressed as inpyrfluxam and gly-CH2OH-S-2840.

Ipconazole

 

 

18 January 2010

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Ipflufenoquin 1.2 125 10 March 2023 Acute neurotoxicity study in rats; a NOAEL of 125 mg/kg bw was based on the reduction in body temperature and the motor activity ambulation and fine movement observed at the next higher dose.  

Isocycloseram

0.08

7.5

18 November 2021

Developmental rat study: a NOAEL of 7.5 mg/kg bw was based on an increased incidence of bifid sternum, which might be attributable to a single exposure at the next higher dose.

 

Isofetamid

3

300

9 March 2017

Developmental rabbit study; a NOAEL of 300 mg/kg bw/d is based on reduced maternal bodyweight gain early in gestation at the next higher dose.

 

Isopyrazam

0.3

30

24 May 2016

Rat acute neurotoxicity study; a NOAEL of 30 mg/kg bw was based on clinical signs of toxicity (weak appearance and decreased activity).

 

Isotianil         ARfD considered to be unnecessary due to its low acute toxicity, the lack of evidence for any acute neurotoxicity and the absence of any other toxicologically relevant effect that might be attributable to a single dose.

Isoxaflutole

 

 

10 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Ivermectin

0.2

1.5

31 January 2018

Human clinical trial; absence of any effects at the highest tested dose of 1.5 mg/kg bw.

 

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J

No results.

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K

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Kaolin

 

 

5 September 2022

 

ARfD considered to be unnecessary due to the absence of any systemic exposure following oral, dermal or inhalation exposure. Calcined kaolin is insoluble in all aqueous and organic solvents that are physiologically relevant.

Ketoprofen

0.001

0.1

8 December 2000

Acute pharmacological rabbit study; a NOAEL of 0.1 mg/kg bw was based on inhibition of platelet aggregation at the next higher dose.

 

Kresoxim-methyl     10 May 2017   ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

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L

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Lactobacillus acidophilus

 

 

4 September 2002

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Lactobacillus brevis

 

 

4 September 2002

 

ARfD unnecessary. Naturally occurring organism– from naturally occurring background levels of the organism.

Lactobacillus casei

 

 

4 September 2002

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Lactobacillus plantarum

 

 

4 September 2002

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Lasalocid     19 April 2021   ARfD considered to be unnecessary due to the absence of any neurological effects or development toxicity after a single dose.

Lignocaine hydrochloride monohydrate

0.03

 

13 June 2023

Human oral pharmaceutical product

Considered to be adequately protective against both local and systemic effects. The point of departure was derived from a short-term human oral over-the-counter pharmaceutical product. A total UF of 32 was used (100.5 for extrapolation from a LOAEL (pharmaceutical effect) to NOAEL and 10 for intraspecies variability).
d-limonene     4 May 2021   ARfD unnecessary. Naturally occurring compound that is also a food additive - residues from its use are unlikely to be distinguishable from naturally occurring background levels.

Lufenuron

 

 

10 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

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M

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Maldison

1.5

15

12 April 2005

Acute oral human study; a NOAEL of 15 mg/kg bw was based on inhibition of RBC and plasma ChE activity at the higher dose.

 

Mancozeb 0.3 30 17 February 2023 Developmental rabbit study: a NOAEL of 30 mg/kg bw/d was based on deaths, clinical signs of toxicity and an increased number of abortions observed at the next higher dose. ARfD for mancozeb only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Mandestrobin

 

 

30 March 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Mandipropamid

 

 

9 April 2010

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Mecoprop

0.5

50

17 January 2001

Developmental rat study; a NOAEL of 50 mg/kg bw/d was based on embryolethality and foetotoxicity (lower bodyweight and shorter CR length) at the next higher dose.

ARfD for mecoprop only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Mecoprop-p (salts and esters)

0.5

50

25 August 2021

Developmental rat study; a NOAEL of 50 mg/kg bw/d was based on embryolethality and foetotoxicity (lower bodyweight and shorter CR length) at the next higher dose.

ARfD for mecoprop-p only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

ARfD for mecoprop-p only applies to women of child-bearing age.

An ARfD for the general population is considered to be unnecessary.

Mecoprop-P (salts and esters) is defined as: The sum of mecoprop-P ((S)-2-(4-chloro-o-tolyloxy)propionic acid), HMCPP ((2S)-2-[4-chloro-2-(hydroxymethyl)phenoxy]propanoic acid; free and conjugated), CCPP (2-[(1S)-1-carboxyethoxy]-5-chlorobenzoic acid) and 4-glucosyl-MPP ((2S)-2-[4-(D-glucopyranosyloxy)-2-methylphenoxy]propanoic acid) expressed as mecoprop-P free acid.

Mefentrifluconazole

 

 

27 November 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Melaleuca Oil

10

1,000

12 August 2010

Based on an in vivo micronucleus study in mice using a default safety factor of 100.

 

Meloxicam

0.004

0.04

4 August 2004

Human clinical trial; a pharmacological NOAEL of 0.04 mg/kg bw/d was based on increased blood pressure, pulse rate and ECG at higher doses.

 

Mesosulfuron-methyl

 

 

18 January 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Mesotrione

 

 

10 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Metalaxyl

 

 

10 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Metamitron

0.1

10

4 December 2017

Developmental rat study; a NOAEL of 10 mg/kg bw/d was based on the observation that acute CNS effects, in particular sedation and lower transient body temperature, occurred at doses in excess of 10 mg/kg bw. The only identified NOAEL of 10 mg/kg bw/d in the toxicological database was observed in a rat developmental study for reduced bodyweight gain. This NOAEL was selected as the basis of the numerical ARfD (EFSA, 2008).

ARfD for metmitron applies to the general population.

Metazachlor

 

 

15 July 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Metcamifen  0.3 30 21 July 2020 Developmental rabbit study; a NOAEL of 30 mg/kg bw/d was based on increased incidence of skeletal and cartilage variants of the vertebrae and ribs, which might be attributable to a single exposure to metcamifen at higher doses. ARfD for metcamifen only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Methamidophos

0.003

0.3

30 January 2004

Acute neurotoxicity rat study; a NOAEL of 0.3 mg/kg bw was based on plasma, RBC and brain ChE inhibition at the next higher dose.

 

Methidathion

0.01

1

31 May 2004

Acute neurotoxicity rat study; a NOAEL of 1 mg/kg bw was based on RBC and brain ChE inhibition at the next higher dose.

 

Methiocarb

0.005

0.5

4 December 2017

Developmental rat study; a NOAEL of 0.5 mg/kg bw/d was based on clinical signs (muscle fasciculation’s) at the next higher dose.

ARfD for methiocarb applies to the general population.

Methomyl

0.02

0.1(H)

5 March 2007

Acute (capsule) human toxicity study; a NOAEL 0.1 mg/kg bw was based on erythrocyte ChE inhibition at the next higher dose.

Source; JMPR 2001.

Methoprene

 

 

10 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Methoxyfenozide

 

 

12 January 2001

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

1-Methylcyclopropene

 

 

10 October 2003

 

There was insufficient information to establish an ARfD, however, based on its proposed pattern of use the dietary intake is likely to be low.

Metobromuron 0.25 25 20 June 2022 Ten-day rat toxicity study; a NOAEL of 25 mg/kg bw was based on an elevated number of blood reticulocytes at the next higher dose.  

Metrafenone

 

 

13 April 2010

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Metribuzin

 

 

18 January 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Mevinphos

0.003

0.025

5 December 2000

28-day human volunteer study; a NOAEL of 0.025 mg/kg bw/d was based on inhibition of RBC ChE activity and clinical signs at the next higher dose.

 

Milbemectin

0.06

6

29 April 2005

Developmental rat study; a NOAEL of 6 mg/kg bw/d was based on reduced maternal bodyweight gain at the next higher dose.

ARfD for milbemectin only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Molinate 0.002 1.8 [LOAEL] 25 February 2022 Rat development neurotoxicity study; a LOAEL of 1.8 mg/kg bw based on the lowest relevant point of departure. A total safety factor of 1000 is applied (10 for extrapolation from the LOAEL to the NOAEL, 10 for interspecies extrapolation and 10 for intraspecies extrapolation).

Monepantel

 

 

31 August 2009

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Moxidectin

0.01

1

28 March 2002

28-day dietary dog study and developmental rabbit study; a NOAEL of 1 mg/kg bw/d was based on neurotoxicity at the next higher dose (in dogs); and maternal toxicity (reduced weight gain) at the next higher dose (in rabbits).

 

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N

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Nicarbazin     19 April 2021   ARfD considered to be unnecessary due to the absence of any neurological effects or developmental toxicity after a single dose.

Niclosamide

 

 

20 September 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Novaluron

 

 

17 January 2001

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Nuclear polyhedrosis virus of helicoverpa armigera occlusion bodies

 

 

17 December 2003

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

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O

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Omethoate

0.003

0.25

20 October 2005

Acute neurotoxicity rat study; a NOAEL of 0.25 mg/kg bw was based on plasma ChE inhibition at the next higher dose.

 

O-phenylphenol (see 2-phenylphenol)

 

 

 

 

 

Oxathiapiprolin

 

 

30 July 2015

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Oxytetracycline

 

 

10 October 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

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P

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Paraquat

0.004

0.45

27 June 2003

1-year chronic feeding dog study; a NOAEL of 0.45 mg/kg bw/d was based on the likelihood that the observed pulmonary lesions would also occur after an acute exposure at the next higher dose.

 

Penflufen

0.5

50

10 October 2012

Acute neurotoxicity rat study; a NOAEL of 50 mg/kg bw was based on decreased motor and locomotor activity at the next higher dose.

 

Phenmedipham

 

 

13 April 2011

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

2-Phenylphenol

 

 

31 July 2003

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose. (JMPR 1999).

Penthiopyrad

1

125

10 February 17

Acute oral neurotoxicity rat study; a NOAEL of 125 mg/kg bw was based on clinical signs (decreased motor activity, decreased body temp, hunched position and unsteady gait) at the next higher dose.

 

Pinoxaden

0.3

30

29 August 2005

Developmental toxicity rabbit study; a NOAEL of 30 mg/kg bw/d was based on early resorption, implantation loss, lower number of live births and reduced foetal weight at the next higher dose.

ARfD for pinoxaden only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Piperonyl butoxide

 

 

17 February 2020

 

ARfD considered unnecessary, due to its low oral toxicity and the absence of any neurological effects or developmental toxicity after a single dose.

Polyoxin D zinc salt     8 June 2021   ARfD considered unnecessary due to its low oral toxicity or the absence of any developmental toxicity after a single dose.

Porcine gonadotrophins

 

 

25 June 2002

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Procymidone

 

 

11 October 2022

 

ARfD considered unnecessary, on the basis that anti-androgenic effects on development are unlikely to occur following a single exposure incident, and the observed effects in the acute neurotoxicity study do not require the establishment of an ARfD.

Prodiamine

 

 

13 October 2021

 

ARfD for prodiamine is not considered necessary due to its low acute oral toxicity and lack of neurological and development effects after a single dose.

Profoxydim

 

 

29 November 2006

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Prohexadione-calcium

 

 

18 January 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Propamocarb

2

200

26 November 2015

Acute neurotoxicity rat study; a NOAEL of 200 mg/kg bw was based on a reduced activity 1 h after dosing at the next higher dose.

 

Propargite

 

 

10 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Propiconazole

0.3

30

30 August 2018

An ARfD of 0.3mg/kg bw was established based on a NOAEL of 30mg/kg bw per day in a developmental toxicity study in rats and a 100-fold safety factor. The NOAEL was identified on the basis of slight increases in rudimentary ribs and unossified sternebrae at 90mg/kg bw per day. This provides an adequate margin over the maternal toxicity and cleft palate seen at 300mg/kg bw per day. The NOAEL is also adequately protective against any acute local effects on the gastrointestinal tract based on the available data in dogs. Ataxia has also been noted in pregnant rats dosed at 360 mg/kg body weight/day.

 

Propineb

0.003

0.32

22 February 2017

Developmental rat study; a NOAEL of 0.32 mg/kg bw/d was based on skeletal variations at the next higher dose.

This group ARfD value which includes propineb and propylene thiourea (PTU) only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Propylene oxide

0.4

205

21 April 2006

Inhalation developmental toxicity rat study; a NOAEC of 300 ppm (equivalent to NOAEL of 205 mg/kg bw/d) was based on increased incidence of 7th cervical rib at the next higher dose.

ARfD for propylene oxide only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Propylene thiourea (PTU)

0.003

0.32

22 February 2017

 

See group ARfD for propineb.

Propyzamide

0.13

40

[LOAEL]

11 December 2018

Based on a LOAEL of 40 mg/kg bw due to acute, reversible neurotoxicity (increased landing foot splay and decreased motor activity; without detectable neuropathology) in rats at this dose.

The total uncertainty factor applied is 3 for LOAEL to NOAEL extrapolation uncertainties, 10 for interspecies uncertainties and 10 for intraspecies uncertainties.

Proquinazid

1

100

10 February 2017

Acute neurotoxicity rat study; a NOAEL of 100 mg/kg bw was based on reduced motor activity at the next higher dose.

 

Prosulfocarb

0.4

40

30 July 2007

Acute neurotoxicity rat study; a NOAEL of 40 mg/kg bw was based on reduced motor activity at the next higher dose.

 

Prothioconazole

0.03

3

28 May 2008

Developmental rat study; a NOAEL of 3 mg/kg bw/d was based on increased incidence of 14th rib, increased resorptions and cleft palate at the next higher dose.

ARfD for prothioconazole only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary. Since the residue definition for risk assessment in all commodities is expressed as prothioconazole-desthio and this metabolite is of higher toxicity than the parent, a group ARfD was established to include prothioconazole-desthio.

Pydiflumetofen

 

 

21 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Pyraclostrobin

0.05

5

26 June 2008

Developmental rabbit study; a NOAEL of 5 mg/kg bw/d was based on early resorptions at the next higher dose.

ARfD for pyraclostrobin only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Pyraflufen-ethyl

0.2

20

17 December 2004

Developmental rabbit study; a NOAEL of 20 mg/kg bw/d was based on increased maternal mortality and morbidity at the next higher dose.

 

Pyrasulfotole

0.2

200 [LOAEL]

20 August 2008

Acute neurotoxicity rat study; based on decreased motor and locomotor activity at a LOAEL of 200 mg/kg bw.

 

Pyrethrins

0.2

20

31 July 2003

Acute neurotoxicity rat study; a NOAEL of 20 mg/kg bw was based on neurotoxicity observed at the next higher dose.

Adopted from JMPR 1999.

Pyridalyl

 

 

29 April 2004

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Pyridate 2 177 12 June 2020 Based on an acute neurotoxicity study in rats. Death occurred within 1 day after dosing at the next higher dose of 500 mg/kg bw. The ARfD applies to pyridate, pyridafol and pyridafol-N-glucoside expressed as pyridate. Adopted from JMPR 2019.

Pyrimethanil

 

 

10 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Pyriofenone

 

 

26 November 2014

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Pyroxasulfone

 

 

27 June 2013

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Pyroxsulam

 

 

14 April 2008

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

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Q

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Quinclorac

2

200

13 September 2004

Acute oral toxicity gavage mouse study; a NOAEL of 200 mg/kg bw was based on clinical signs at the next higher dose.

 

Quinoxyfen

 

 

15 January 2002

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

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R

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Ractopamine hydrochloride

0.001

0.13

30 July 2002

Human study; a NOAEL of 0.13 mg/kg bw was based on increased heart rate at the next higher dose.

 

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S

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Saccharomyces cerevisiae

 

 

4 September 2002

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Saflufenacil

0.05

5

13 February 2017

Developmental rat study; a NOAEL of 5 mg/kg bw/d was based on an increased incidence of bent scapula and wavy ribs in the absence of maternal toxicity at the next higher dose.

ARfD for saflufenacil only applies to women of child-bearing age. An ARfD for the general population is considered to be unnecessary.

Sedaxane

 

 

24 April 2011

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Spinetoram

 

 

5 May 2008

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Spinosad

 

 

10 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Spirotetramat

1

100

26 May 2008

Acute neurotoxicity rat study; a NOAEL of 100 mg/kg bw was based on clinical signs and decreased motor activity at the next higher dose.

 

Spiroxamine

0.2

20

2 July 2001

Acute neurotoxicity rat study; a NOAEL of 20 mg/kg bw was based on decrease in landing footsplay at the next higher dose.

 

Streptomyces lydicus

 

 

7 June 2016

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Sulfoxaflor

0.25

25

27 June 2013

Acute oral neurotoxicity rat study; a NOAEL of 25 mg/kg bw was based on decreased motor activity at the next higher dose.

 

Sulfuryl Fluoride

0.3

31

24 August 2006

Acute inhalational neurotoxicity rat study; a NOAEL of 31 mg/kg bw (300 ppm) was based on the absence of any observed effects at the highest tested concentration of 300 ppm.

 

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T

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Tebuconazole

0.1

10

10 February 2023

Rabbit pre-natal developmental toxicity study; a NOAEL of 10 mg/kg bw/d due to the presence of disordered development (increased incidence of embryonic resorptions, abdominal fissures, and incidence of litters with abnormal foetuses) at the next highest dose.

ARfD for tebuconzole only applies to women of child-bearing age. An ARfD for the general population is not required. The NOAEL for maternotoxicity is  3 mg/kg bw/d due to slight hepatotoxicity at the next highest dose. The degree of maternotoxicity is insufficient to explain the developmental effects.

Tepraloxydim

 

 

13 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Terbuthylazine

 

 

4 May 2001

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Tetraconazole

0.2

16

12 December 2002

4-week dietary rat study; a NOAEL of 16 mg/kg bw/d was based on clinical signs at the next higher dose.

 

Tetraniliprole     17 July 2019   ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose .

Thiacloprid

0.03

3.1

20 July 2001

Acute oral neurotoxicity rat study; a NOAEL of 3.1 mg/kg bw was based on reduced motor & locomotor activity at the next higher dose.

 

Thiram

0.1

10

2 July 2010

Acute neurotoxicity rat study; a NOAEL of 10 mg/kg bw was based on reduced locomotor activity at the next higher dose.

 

Thymol     19 August 2020   ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.
Tiafenacil 0.006 0.6 22 December 2020 One-generation rat reproductive study. A NOAEL of 0.6 mg/kg bw/d was based on increased total liver porphyrins at the next higher dose.  

Tilmicosin

0.4

36

29 August 2002

7-day oral dosing (capsule) dog study; a NOAEL of 10 mg/kg bw/d was based on the absence of clinical signs (ataxia, dyspnoea, bilateral mydriasis) during the first 4 days of dosing.

 

Tolfenamic acid

0.005

[0.5]

16 January 2001

Lowest effective therapeutic dose (as a single dose) for treatment of pyresis in children.

 

Toltrazuril 0.02 2 26 March 2020 Rabbit developmental studies; an overall NOAEL of 2 mg/kg bw/d with foetotoxicity at the next higher dose.  

Topramezone

 

 

16 June 2016

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Trifloxystrobin

 

 

10 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Trifloxysulfuron

 

 

13 February 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Trifludimoxazin     28 May 2020   An ARfD was considered unnecessary due to its low oral toxicity and the absence of any neurological effects or developmental toxicity after a single dose.

Trinexapac-ethyl

 

 

10 May 2017

 

ARfD considered to be unnecessary due to its low oral toxicity and the absence of any developmental toxicity after a single dose.

Tulathromycin

0.1

100

16 August 2006

Acute tolerance dog study; a LOAEL of 100 mg/kg bw was based on the occurrence of emesis and loose stools.

 

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U

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Ulocladium oudemansii

 

 

12 December 2003

 

ARfD unnecessary. Naturally occurring organism– residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

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V

No results.

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W

No results.

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X

No results.

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Y

No results.

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Z

Chemical

ARfD (mg/kg bw)

NOAEL (mg/kg bw)

Date

Study

Comments

Zilpaterol

0.00004

0.00076[LOAEL]

24 October 2016

Single dose human study; a LOAEL of 0.05 mg/person (equal to 0.00076 mg/kg bw) was based on the observation of tremors at the lowest tested dose.

 

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