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Diss Factsheets

Ecotoxicological information

Toxicity to birds

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Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
experimental study
Adequacy of study:
supporting study
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
Specific details on test material used for the study:
- Substance ID: TSN 100010
- Name of substance: XDE-795
- Purity: 99%
Dose method:
gavage
Analytical monitoring:
no
Vehicle:
yes
Remarks:
corn oil
Test organisms (species):
Colinus virginianus
Limit test:
no
Remarks:
Single dose
Post exposure observation period:
14 days
No. of animals per sex per dose and/or stage:
5
Control animals:
yes
Nominal and measured doses / concentrations:
Nominal concentrations: 292, 486, 810, 1350, and 2250 mg a.i./kg bw
Reference substance (positive control):
no
Key result
Dose descriptor:
LD50
Effect level:
2 250 mg/kg bw
Conc. / dose based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: highest dose tested
Dose descriptor:
NOEL
Effect level:
< 292 mg/kg bw
Conc. / dose based on:
act. ingr.
Basis for effect:
other: body weight and feed consumption
Validity criteria fulfilled:
yes
Conclusions:
LD50 (Northern bobwhite): >2250 mg/kg bw (highest dose tested)
NOEL (Northern bobwhite): <292 mg/kg bw (body weight and feed consumption)
Executive summary:

The study was conducted to evaluate the acute toxicity of the test substance administered to the Northern bobwhite as a single oral dose. The study was conducted following EPA OPP 71-1.

Bobwhite were dosed at nominal concentrations of 292, 486, 810, 1350, and 2250 mg a.i./kg bw. Treatment and control birds were observed for 14 days after dosing.

There were no treatment related mortalities or overt signs of toxicity at any of the dosages tested. When compared to the controls, there was a dose responsive loss in body weight or reduction in body weight gain among all birds at all dosage levels during days 0-3. A continued loss in body weight was noted among all birds at 2250 mg a.i./kg during days 4-7. A reduction in feed consumption was seen for males at 292 and 486 mg a.i./kg and among all birds at 810, 1350 and 2250 mg a.i./kg during days 4-7.

In conclusion, the acute oral LD50 value for northern bobwhite exposed to the test substance was determined to be greater than 2250 mg a.i./kg, the highest dosage tested. The no mortality level was 2250 mg a.i./kg. The no observed effect level was lower than 292 mg a.i./kg, based on the reduction in body weight and feed consumption noted among birds at 292 mg a.i./kg.

Endpoint:
long-term toxicity to birds: reproduction test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 206 (Avian Reproduction Test)
Deviations:
yes
Remarks:
The temperature within the incubator during the incubation phase should be 37 to 38°C (99.0 to 99.5°F). The minimum temperature in the incubator housing the chicks was noted to be 80°F. This did not effect the quality and integrity of the study.
Qualifier:
according to guideline
Guideline:
EPA OPP 71-4 (Avian Reproduction Test)
Deviations:
yes
Remarks:
The temperature within the incubator during the incubation phase should be 37 to 38°C (99.0 to 99.5°F). The minimum temperature in the incubator housing the chicks was noted to be 80°F. This did not effect the quality and integrity of the study.
GLP compliance:
yes
Specific details on test material used for the study:
- Lot number: DECO-97-152-1
- Purity: 97.4%
Dose method:
feed
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
diet
Test organisms (species):
Colinus virginianus
Limit test:
no
Remarks:
F0 generation test period: 23 weeks; F1 generation growth period: 13 weeks
No. of animals per sex per dose and/or stage:
16
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
Nominal concentrations: 250, 500, 1000 ppm a.i.
Reference substance (positive control):
no
Key result
Duration (if not single dose):
23 wk
Dose descriptor:
other: NOAEL
Effect level:
1 000 other: ppm
Conc. / dose based on:
act. ingr.
Basis for effect:
other: parental systemic toxicity, reproduction and F1 generation
Remarks on result:
other: highest concentration tested
Validity criteria fulfilled:
yes
Conclusions:
NOAEL (Bobwhite quail): 1000 ppm a.i., highest concentration tested (parental systemic toxicity, reproduction and F1 generation)
Executive summary:

The dietary reproductive toxicity study was conducted to determine the effects of the test substance on young adult male and female Bobwhite quail in their first breeding season. The study was conducted following OECD guideline 206 and EPA OPP 71-4.

Dietary levels of 0, 250, 500, and 1000 ppm a.i. were chosen and the Bobwhite quail received their respective test diets for 161 days.

The ingestion of the test substance by the parental generation at levels of 250, 500, or 1000 ppm a.i. produced no statistically significant effects (p >0.05) on body weights, feed consumption, and reproductive success of the F0 generation, or on body weights, feed consumption, and survivability of the F1 generation.

Based on the lack of treatment-related effects on parental systemic toxicity, reproduction, and for the F1 generation, the No-Observed-Adverse-Effect Level (NOAEL) was 1000 ppm a.i.

Endpoint:
long-term toxicity to birds: reproduction test
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 206 (Avian Reproduction Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 71-4 (Avian Reproduction Test)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Lot number: DECO-97-152-1
- Purity: 97.4%
Dose method:
feed
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
diet
Test organisms (species):
Anas platyrhynchos
Limit test:
no
Remarks:
F0 generation test period: 21 weeks; F1 generation growth period: 12 weeks
No. of animals per sex per dose and/or stage:
16
Control animals:
yes, plain diet
Nominal and measured doses / concentrations:
Nominal concentrations: 250, 500, 1000 ppm a.i.
Reference substance (positive control):
no
Key result
Duration (if not single dose):
21 wk
Dose descriptor:
other: NOAEL
Effect level:
1 000 other: ppm
Conc. / dose based on:
act. ingr.
Basis for effect:
signs of toxicity
Remarks on result:
other: highest concentration tested
Key result
Duration (if not single dose):
21 wk
Dose descriptor:
other: NOAEL
Effect level:
500 other: ppm
Conc. / dose based on:
act. ingr.
Remarks:
47.7 mg a.s./kg bw/day
Basis for effect:
other: reproductive success and F1 generation
Validity criteria fulfilled:
yes
Conclusions:
NOAEL (Mallard duck): 1000 ppm a.i. (parental systemic toxicity) (highest concentration tested)
NOAEL (Mallard duck): 500 ppm a.i. (reproductive success and F1 generation)
Executive summary:

The dietary reproductive toxicity study was conducted to determine the effects of the test substance on young adult male and female mallard ducks in their first breeding season. The study was conducted following OECD guideline 206 and EPA OPP 71-4.

Dietary levels of 0, 250, 500, and 1000 ppm a.i. were chosen and the Mallard ducks received their respective test diets for 147 days.

The ingestion of the test substance by the parental generation at levels of 250 or 500 ppm a.i. produced no biologically significant effects (P >0.05) on adult body weights, adult feed consumption, reproductive success of the F0 generation, hatchling body weights, hatchling feed consumption, and survivability of the F1 generation. Similarly, the ingestion of the test substance by the parental generation at a level of 1000 ppm a.i. produced no biologically significant effects on any of the aforementioned parameters, except for reproductive success of the F0 generation and survivability of the F1 generation. Treatment-related adverse effects were noted for these variables.

The No-Observed-Adverse-Effect Level for this study was determined to be 1000 ppm a.i. for the parental generation and 500 ppm a.i. for reproductive success and for the F1 generation.

Description of key information

21-week NOAEL (Mallard duck): 1000 ppm a.i. (highest concentration tested, parental) and systemic 500 ppm a.i. (reproductive success and F1 generation); OECD 206; Reliability = 1

23-week NOAEL (Bobwhite quail): 1000 ppm (highest dose tested); OECD 206; Reliability = 1

Oral LD50 (Northern bobwhite): >2250 mg/kg bw (highest dose tested); EPA OPP 71-1; Reliability = 1

Key value for chemical safety assessment

Short-term EC50 or LC50 for birds:
2 250 mg/kg food

Additional information