Orthosulfamuron

Toxicity to birds

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to birds: acute oral toxicity test (LD50-slope)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

14 Day 14 March 2001-28 March 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 71-1 (Avian Acute Oral Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Test material:
IR5878
Batch number: FCF/T/172-00 (ex 20525/03/8)
Purity: 97.99 ± 0.39 %

Dose method:

feed

Analytical monitoring:

yes

Vehicle:

yes

Details on preparation and analysis of diet:

Groups of 5 male and 5 female adult birds were given a single oral dose, by intubation of either 500, 1000 or 2000 mg IR5878/kg bw in corn oil, at the rate of 5 mL/kg bw. A similar sized control group was dosed in the same way receiving the vehicle only (corn oil). Birds were observed for 14 days following dosing. Observations included mortality, clinical signs, bodyweight, food consumption and post mortem examination.

Test organisms (species):

Anas platyrhynchos

Details on test organisms:

Species and Strain: Male and Female adult Mallard ducks (Anas platyrhynchos)
Body weight: 952 ÷ 1235 g (at start of acclimatation); 868 ÷ 1169 g (day of treatment)
Housing: 5 animals/sex/floor pen.

Post exposure observation period:

14 days

No. of animals per sex per dose and/or stage:

five male and five female

Control animals:

yes

yes, concurrent vehicle

Nominal and measured doses / concentrations:

500, 1000 or 2000 mg IR5878/kg bw in corn oil, at the rate of 5 mL/kg bw

Details on test conditions:

ACCLIMATION
- Acclimation period: Stock maintained at laboratory

FEED WITHHOLDING PERIOD BEFORE DOSING
- No. of hours: 19 hours

PEN SIZE AND CONSTRUCTION MATERIALS
- Description: floor pens, galvanised steel
- Floor covering: mesh
- Compliant to good husbandry practices: yes
- Suitable to avoid crowding stress: yes
- Caging: groups of five

Details on examinations and observations:

Bired were observed daily during the study and at frequent intervals during the post treatment period. Mortalities, bird health and clinical signs were recorded at each observation. Any bird found dead during the study was examined post mortem.

Reference substance (positive control):

no

Key result

Dose descriptor:

NOEC

Effect level:

> 2 000 mg/kg bw

Conc. / dose based on:

act. ingr.

Basis for effect:

signs of toxicity

Mortality and sub-lethal effects:

One mortality occurred in the control group on day 5 but was not preceded by clinical signs. All other birds remained in good health.Body weights were unaffected by treatment with IR5878.

Reported statistics and error estimates:

One mortality occurred in the control group on day 5, but was not preceded by any clinical signs. All the other birds remained in good health throughout the study.
Bodyweights and food consumption were unaffected by treatment with IR5878.
No abnormalities were detected in any bird examined at post mortem.

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of this study the acute oral LD50 value of IR5878 to the Mallard Duck was found to be in excess of 2000 mg/kg. The no observed effect level was considered to be 2000mg/kg the highest treatment level tested. IR5878 is of low toxicity to birds.

Executive summary:

A study was performed to assess the acute oral toxicity of IR5878 to the Mallard duck. The method followed was that described in the United States Environmental Protection Agency Pesticide Assessment Guidelines, Subdivision E, Hazard Evaluation: Wildlife and Aquatic Organisms, Series 71 - Avian and Mammalian Testng 71 -1 Avian single dose oral LD50 test dated October 1982 and draft revised guideline dated March 1988.

Groups of five male and five female adult birds were given a single oral dose by inhalation of either 500, 1000, 2000 mg IR5878/kg body weight. A similar sized control group was dosed in the same way receiving the vehicle only (corn oil). Birds were observed for 14 days following dosing. Observations included mortality, clinical signs, bodyweight, food consumption and post mortem examination.

One mortality occurred in the control group. There were no mortalities in any of the treated groups and no clinical signs of toxicity were observed.

Bodyweights and food consumption were unaffected by treatment with IR5878.

The acute oral LD50 value of IR5878 to the Mallard Duck was found to be in excess of 200 0mg/kg. The no observed effect level was considered to be 2000mg/kg the highest treatment level tested.

Reference 2

Endpoint:

short-term toxicity to birds: acute oral toxicity test (LD50-only)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

JAnuary 2001- April 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 71-1 (Avian Acute Oral Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Test material:
IR5878
Batch number: FCF/T/172-00 (ex 20525/03/8)
Purity: 97.99 ± 0.39 %

Dose method:

feed

Vehicle:

yes

Test organisms (species):

Colinus virginianus

Details on test organisms:

Species and Strain: Male and Female adult Bobwhite quail (Colinus virginianus)
Age: approximately 8 months old at start of pre-treatment period
Body weight: 181 ÷ 219 g (at start of acclimatation); 178 ÷ 219 g (day of treatment)
Housing: 2 or 3 animals/sex/tiered cage.

Post exposure observation period:

14 days

No. of animals per sex per dose and/or stage:

Groups of 5 male and 5 female adult birds were given a single oral dose, by intubation of either 500, 1000 or 2000 mg IR5878/kg bw in corn oil. A similar sized control group was dosed in the same way receiving the vehicle only (corn oil).

Control animals:

yes

yes, concurrent vehicle

Nominal and measured doses / concentrations:

500, 1000 or 2000 mg IR5878/kg bw in corn oil

Details on examinations and observations:

A study was performed to assess the acute oral toxicity of IR5878 to the Bobwhite quail.
Groups of 5 male and 5 female adult birds were given a single oral dose, by intubation of either 500, 1000 or 2000 mg IR5878/kg bw in corn oil, at the rate of 10 mL/kg bw. A similar sized control group was dosed in the same way receiving the vehicle only (corn oil). Birds were observed for 14 days following dosing. Observations included mortality, clinical signs, bodyweight, food consumption and post mortem examination.

Reference substance (positive control):

no

Key result

Dose descriptor:

NOEC

Effect level:

> 2 000 mg/kg bw

Conc. / dose based on:

act. ingr.

Basis for effect:

signs of toxicity

Mortality and sub-lethal effects:

No mortalities occurred during the study and no clinical signs of toxicity were observed in any bird.

Further details on results:

Bodyweights and food consumption were unaffected by treatment with IR5878.
No abnormalities were detected in any bird examined at post mortem.

Validity criteria fulfilled:

yes

Conclusions:

No mortalities occurred during the study and no clinical signs of toxicity were observed in any bird.
Bodyweights and food consumption were unaffected by treatment with IR5878.
No abnormalities were detected in any bird examined at post mortem.

Executive summary:

A study was performed to assess the acute oral toxicity (LD50) of IR5878 to the Bobwhite quail. The method followed was that described in the United States Environmental Protection Agency Pesticide Assessment Guidelines, Subdivision E, Hazard Evaluation: Wildlife and Aquatic Organisms, Series 71 - Avian and Mammalian Testing 71 -1 Avian single-dose oral LD50 dated October 1982 and draft revised guideline dated March 1988.

Groups of five male and five female adult birds were given a single oral dose by intubation of either 500, 1000, 2000 IR 5878 /kg bodyweight. A similar sized control group was dosed in the same way receiving the vehicle only (corn oil). Birds were observed for 14 days following dosing. Observations included mortality, clinical signs, body weight and food consumption and post mortem examination.

No mortalities were detected in any bird at post mortem examination.

The acute oral LD50 value of IR5878 to the Bobwhite quail was found to be in excess of 2000mg/kg. The no observed effect level was considered to be 2000mg/kg the highest treatment level tested.

Description of key information

Under the conditions of the first study the acute oral LD50 value of IR5878 to the Mallard Duck was found to be in excess of 2000 mg/kg. The no observed effect level was considered to be 2000mg/kg the highest treatment level tested. IR5878 is of low toxicity to birds.

In the second study the acute oral LD50 value of IR5878 to the Bobwhite quail was found to be in excess of 2000mg/kg. The no observed effect level was considered to be 2000mg/kg the highest treatment level tested.