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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:
key study
Study period:
February to March 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The reliability rating is a 1 because the study followed a standard guideline, which describes a procedure designed to evaluate this endpoint, and the results were reviewed for reliability and assessed as valid. The study was conducted under GLP.
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
EPA OPP 71-1 (Avian Acute Oral Toxicity Test)
Deviations:
no
GLP compliance:
yes
Dose method:
gavage
Analytical monitoring:
yes
Vehicle:
yes
Test organisms (species):
Colinus virginianus
Details on test organisms:
All Northern Bobwhite (Colinus Virginianus) were 26 weeks of age and appeared to be in good health at initiation of the test. Bobwhite ranged in weight from 189 to 234 grams at test initiation. The birds were obtained from Top Flight Quail Farm, Belvidere, NJ, USA. Test birds were reproductively immature and maintained separately by sex. All birds were from the same hatch, pen reared, and phenotypically indistinguishable from wild birds. Individual birds were identified with colored leg bands. All tests birds were acclimated to the caging and facilities for 11 weeks prior to the initiation of the test.
Limit test:
no
Remarks:
Single oral dose
Post exposure observation period:
14 days
No. of animals per sex per dose and/or stage:
5 animals per sex per dose (total of 10 animals per dose)
Control animals:
yes, concurrent vehicle
Nominal and measured doses / concentrations:
A single dose of test material was administered by oral gavage to Northern Bobwhite quail at concentrations of 0, 292, 486, 810, 1350, and 2250 mg/kg bodyweight. The substance was dispersed in corn oil. Samples of the dosing solutions were analyzed for dosage verfication.
Details on test conditions:
Test birds were held in galvanized wire pens with 78 x 51 cm floor space. Average temperature was 20.3± 1.7°C, with a relative humidity of 44% ±12%. Photoperiod was 8 hours of light per day.
Details on examinations and observations:
During acclimation, all birds were observed daily. Following test initiation, all birds were observed at least twice daily. Body weights were measured individually at initiation of the test and by groups on Days 3, 7, and 14.
Details on reproductive parameters:
Animals were immature
Reference substance (positive control):
no
Key result
Duration (if not bolus):
14 d
Dose descriptor:
LD50
Effect level:
> 2 250 mg/kg bw
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Key result
Duration (if not bolus):
14 d
Dose descriptor:
NOEL
Effect level:
292 mg/kg bw
Conc. / dose based on:
test mat.
Basis for effect:
body weight
Remarks:
based on weight loss at this level
Mortality and sub-lethal effects:
There were no mortalities or overt signs of toxicity at any of the dosages tested. When compared to the controls, there was a slight effect upon body weight among birds at 292 and 486 mg/kg body weight during days 0 to 3. There was no difference in body weight between controls and birds at 292 and 486 mg/kg bw during the remainder of the study. There was a dose responsive reduction in body weight among birds at 810, 1350, and 2250 mg/kg bw during days 0 to 3. However, birds in these groups showed a weight gain through the remainder of the study and by day 14 there was no difference in body weights between the control group and the 3 high dose levels. A reduction in feed consumption was noted among females at 1350 mg/kg bw, and all birds at 2250 mg/kg bw for days 0 to 3.
Effects on reproduction:
Endpoint not studied.
Results with reference substance (positive control):
No reference substance tested other than vehicle controls.
Validity criteria fulfilled:
yes
Conclusions:
Hydrocarbons, C9, aromatics is not expected to produce acute toxic effects in birds.
Executive summary:

This study was done to determine the acute oral toxicity of Hydrocarbons, C9, aromatics to Northern Bobwhite Quail. A single dose of 0, 292, 486, 810, or 2250 mg/Kg bw of test substance was administered by oral gavage to 5 female and 5 male Northern Bobwhite Quail per dose. Animals were then examined twice daily for the next 14 days, and body weights taken at test initiaion and days 3, 7, and 14. The acute oral LD50 value as a single oral dose was determined to be greater than 2250 mg/Kg bw, the highest dose tested, based on the lack of mortality observed in all dosage groups. The no mortality level was 2250 mg/Kg bw. The no observed effect level was lower than 292 mg/Kg bw based on the slight reduction in body weight noted at this dosage.

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The reliability rating is a 1 because the study followed a standard guideline, which describes a procedure designed to evaluate this endpoint, and the results were reviewed for reliability and assessed as valid. The study was also conducted under GLP.
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
EPA OPP 71-2 (Avian Dietary Toxicity Test)
Deviations:
no
GLP compliance:
yes
Dose method:
feed
Analytical monitoring:
yes
Vehicle:
yes
Details on preparation and analysis of diet:
Test diets were prepared by mixing the test substance into the diet with corn oil. The concentration of the corn oil in the treated and control diets was 2%. Test material was administered to Northern Bobwhite Quail in the diet for 5 days at concentrations of 0, 842, 1404, 2340, 3900, and 6500 ppm (mg/kg feed).
Test organisms (species):
Colinus virginianus
Details on test organisms:
All Northern Bobwhite (Colinus virginianus) were 10 days of age and appeared to be in good health at initiation of the test. The birds were obtained from Wildlife International Ltd. production flock. Test birds were reproductively immature and could not be differentiated by sex. All birds were from the same hatch, pen reared and phenotypically indistinguishable from wild birds.
Limit test:
no
Total exposure duration (if not bolus):
5 d
Post exposure observation period:
3 days
No. of animals per sex per dose and/or stage:
10 animals per dose. Immature and not sexed.
Control animals:
yes, concurrent vehicle
Nominal and measured doses / concentrations:
Test material was administered to Northern Bobwhite Quail in the diet for 5 days at concentrations of 0, 842, 1404, 2340, 3900, and 6500 ppm (mg/kg feed). Test material concentrations in feed were analytically verified by a GC-FID procedure. Only 3 dosages were analyzed. The 1404, 2340, and 3900 ppm (mg/kg feed) test concentrations were determined as 1320 ppm (94%), 2176 ppm (93%), and 3822 (98%), respectively.
Details on test conditions:
Test birds were held in galvanized wire pens, by group, with 72 x 90 cm floor space. Average temperature was 21.6 ±2ºC, with a relative humidity of 20%±6%. Photoperiod was 16 hours of light per day.
Details on examinations and observations:
During acclimation, all birds were observed daily. Following test initiation, all birds were observed at least twice daily. Body weights were measured grouped, at initiation of the test and on days 5, and 8 (termination).
Details on reproductive parameters:
Animals were immature.
Reference substance (positive control):
no
Key result
Duration (if not bolus):
5 d
Dose descriptor:
NOEL
Effect level:
2 340 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
other: appearance and behaviour
Duration (if not bolus):
5 d
Dose descriptor:
other: LC0
Effect level:
6 500 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Mortality and sub-lethal effects:
There were no mortalities or overt signs of toxicity at any of the dosages tested. Sublethal effects (appearance and behavior) were observed in the two high concentration gruops, 3900, and 6500 ppm, and began on day 4 and day 1, respectively. For both of these dose group, on day 7 till the end of the study, all birds were normal in appearance and behavior. No sublethal effects (appearance and behavior) were noted in any other treatment groups. When compared to the controls, there was no effect on body weight or feed consumption at any concentration tested.
Effects on reproduction:
Animals were immature.
Results with reference substance (positive control):
No reference substance.
Validity criteria fulfilled:
yes
Conclusions:
Hydrocarbons, C9, aromatics is not expected to produce acute toxic effects in birds.
Executive summary:

The study was done to determine the acute toxicity of Hydrocarbons, C9, aromatics to birds when exposed throught the diet. Ten Northern Bobwhite Quail per group of unknown sex were fed diets containing 0, 842, 1404, 2340, 3900, or 6500 ppm of test substance for five days. Animals were examined twice daily after test initiation through the end of the test on day 8. Animals were weighed at test initiaion and days 5 and 8. The acute oral LC50 value for Northern Bobwhite quail was determined to be greater than 6500 ppm (mg/Kg feed), the highest dose tested, based on the lack of mortality observed in all dosage groups. The no observed effect level was 2340 ppm (mg/Kg feed) based on sublethal effects (appearance and behavior).

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5-Mar-1992 to 13-Mar-1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The reliability rating is a 1 because the study followed a standard guideline, which describes a procedure designed to evaluate this endpoint, and the results were reviewed for reliability and assessed as valid. The study was also conducted under GLP.
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
EPA OPP 71-2 (Avian Dietary Toxicity Test)
Deviations:
no
GLP compliance:
yes
Dose method:
feed
Analytical monitoring:
yes
Vehicle:
yes
Details on preparation and analysis of diet:
Test diets were prepared by mixing the test substance into the diet with corn oil. The concentration of the corn oil in the treated and control diets was 2%. Test material was administered to Northern Bobwhite Quail in the diet for 5 days at concentrations of 0, 842, 1404, 2340, 3900, and 6500 ppm (mg/kg feed).
Test organisms (species):
Colinus virginianus
Details on test organisms:
All northern bobwhite (Colinus virginianus) were 10 days of age and appeared to be in good health at initiation of the test. The birds were obtained from Wildlife International Ltd. production flock. Test birds were reproductively immature and could not be differentiated by sex. All birds were from the same hatch, pen reared and phenotypically indistinguishable from wild birds.
Limit test:
no
Total exposure duration (if not bolus):
5 d
Post exposure observation period:
3 days
No. of animals per sex per dose and/or stage:
10 animals per dose. Immature and not sexed.
Control animals:
yes, concurrent vehicle
Nominal and measured doses / concentrations:
Test material was administered to Northern Bobwhite Quail in the diet for 5 days at concentrations of 0, 842, 1404, 2340, 3900, and 6500 ppm (mg/kg feed).
Details on test conditions:
Test birds were held in galvanized wire pens, by group, with 72 x 90 cm floor space. Average temperature was 23.3°C ± 1.3°C, with a relative humidity of 37% ± 11%. Photoperiod was 16 hours of light per day.
Details on examinations and observations:
During acclimation, all birds were observed daily. Following test initiation, all birds were observed at least twice daily. Body weights were measured grouped at initiation of the test and on Days 5 and 8 (termination).
Details on reproductive parameters:
Animals were immature.
Reference substance (positive control):
no
Key result
Duration (if not bolus):
5 d
Dose descriptor:
NOEL
Effect level:
842 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
signs of toxicity
Duration (if not bolus):
5 d
Dose descriptor:
other: LC0
Effect level:
6 500 other: ppm (mg/kg feed)
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Mortality and sub-lethal effects:
No treatment- related mortality occurred. Sublethal effects (appearance and behavior) were observed in the 1404 to 6500 ppm concentrations, which began on day 6, or as early as day 1 at the highest dose level. In each instance, by day 8 till the end of the study for each of these concentrations, all birds were normal in appearance and behavior. When compared to the controls, there may have been a slight reduction in body weight gain among birds at 3900 ppm during the exposure period, days 0-5. A reduction in body weight gain was noted among all birds at 6500 ppm during the same time period. There did not appear to be an effect on food consumption at any concentration tested. The no observed effect level was 842 ppm, based on the signs of toxicity noted at 1404 ppm.
Effects on reproduction:
Animals were immature.
Results with reference substance (positive control):
No reference substance.
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of hydrocarbons, C10, aromatics, >1% naphthalene, as measured by mortality to northern bobwhite (Colinus virginianus) was evaluated in the diet. Under the conditions of this study, hydrocarbons, C10, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 6500 ppm, the highest dosage tested. The No Observed Effect Level was 842 ppm, based on signs of toxicity noted at the 1404 ppm level.
Executive summary:

The acute toxicity of hydrocarbons, C10, aromatics, >1% naphthalene, as measured by mortality to northern bobwhite (Colinus virginianus) was evaluated in the diet. Under the conditions of this study, hydrocarbons, C10, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 6500 ppm, the highest dosage tested. The No Observed Effect Level was 842 ppm, based on signs of toxicity noted at the 1404 ppm level.

Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14-Feb-1992 to 28-Feb-1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The reliability rating is a 1 because the study followed a standard guideline, which describes a procedure designed to evaluate this endpoint, and the results were reviewed for reliability and assessed as valid. The study was also conducted under GLP.
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
EPA OPP 71-1 (Avian Acute Oral Toxicity Test)
Deviations:
no
GLP compliance:
yes
Dose method:
gavage
Vehicle:
yes
Test organisms (species):
Colinus virginianus
Details on test organisms:
All northern bobwhite (Colinus virginianus) were 25 weeks of age and appeared to be in good health at initiation of the test. Bobwhite ranged in weight from 175 to 223 grams at test initiation. The birds were obtained from Top Flight Quail Farm, Belvidere, NJ, USA. Test birds were reproductively immature and maintained separately by sex. All birds were from the same hatch, pen reared and phenotypically indistinguishable from wild birds. Individual birds were identified with colored leg bands. All test birds were acclimated to the caging and facilities for 9 weeks prior to the initiation of the test.
Limit test:
no
Remarks:
Single oral dose
Post exposure observation period:
14 days
No. of animals per sex per dose and/or stage:
5 animals per sex per dose (total of 10 animals per dose).
Control animals:
yes, concurrent vehicle
Nominal and measured doses / concentrations:
Test material was administered by oral gavage to Northern Bobwhite Quail at concentrations of 0, 292, 486, 810, 1350, and 2250 mg/kg bodyweight. The test substance was dispersed in corn oil. Samples of the dosing solutions were analyzed for dosage verification.
Details on test conditions:
Test birds were held in galvanized wire pens with 78 x 51 cm floor space. Average temperature was 20.0°C ± 1.3°C, with a relative humidity of 43% ± 7%. Photoperiod was 8 hours of light per day.
Details on examinations and observations:
During acclimation, all birds were observed daily. Following test initiation, all birds were observed at least twice daily. Body weights were measured individually at initiation of the test and by groups on Days 3, 7, and 14.
Reference substance (positive control):
no
Key result
Duration (if not bolus):
14 d
Dose descriptor:
NOEL
Effect level:
486 mg/kg bw
Conc. / dose based on:
test mat.
Basis for effect:
body weight
Remarks:
Based on body weight loss among females at 810 mg/kg
Duration (if not bolus):
14 d
Dose descriptor:
other: LD0
Effect level:
2 250 mg/kg bw
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Mortality and sub-lethal effects:
No treatment-related mortality occurred. When compared to the controls, there was a reduction in body weight gain among females at 1350 mg/kg and a loss in body weight among females at 810 mg/kg, males at 1350 mg/kg, and all birds at 2250 mg/kg during days 0-3. The no observed effect level was 486 mg/kg, based on the loss in body weight among females at 810 mg/kg.
Effects on reproduction:
Endpoint not studied.
Results with reference substance (positive control):
No reference substance tested other than vehicle control.
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of hydrocarbons, C10, aromatics, >1% naphthalene, as measured by mortality to northern bobwhite (Colinus virginianus) was evaluated as a single oral dose. Under the conditions of this study, hydrocarbons, C10, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 2250 mg/Kg, the highest dosage tested. The No Observed Effect Level was 486 mg/Kg, based on the loss of body weight among females at the 810 mg/Kg level.
Executive summary:

The acute toxicity of hydrocarbons, C10, aromatics, >1% naphthalene, as measured by mortality to northern bobwhite (Colinus virginianus) was evaluated as a single oral dose. Under the conditions of this study, hydrocarbons, C10, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 2250 mg/Kg, the highest dosage tested. The No Observed Effect Level was 486 mg/Kg, based on the loss of body weight among females at the 810 mg/Kg level.

Endpoint:
long-term toxicity to birds: reproduction test
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.

 

The acute oral LD50 value as a single oral dose for hydrocarbons, C9, aromatics was determined to be greater than 2,250 mg/kg body weight, the highest dose tested, based on the lack of mortality observed in all dosage groups in the Northern Bobwhite (Colinus Virginianus). The dietary LD50 in the Northern Bobwhite (Colinus Virginianus) was greater than 6500 ppm, the highest dose tested. There did not appear to be an effect on food consumption at any concentration tested. The no observed effect level was 842 ppm, based on the signs of toxicity noted at 1404 ppm.

 

The acute toxicity of hydrocarbons, C10, aromatics, >1% naphthalene, as measured by mortality to northern bobwhite (Colinus virginianus) was evaluated as a single oral dose. Under the conditions of the study, hydrocarbons, C10, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 2250 mg/Kg, the highest dosage tested. The No Observed Effect Level was 486 mg/Kg, based on the loss of body weight among females at the 810 mg/Kg level. The acute toxicity of hydrocarbons, C10, aromatics, >1% naphthalene, as measured by mortality to northern bobwhite (Colinus virginianus) was also evaluated in the diet. Under the conditions of the study, hydrocarbons, C10, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 6500 ppm, the highest dosage tested. The No Observed Effect Level was 842 ppm, based on signs of toxicity noted at the 1404 ppm level.

Key value for chemical safety assessment

Additional information

The acute oral LD50 value as a single oral dose for hydrocarbons, C9, aromatics was determined to be greater than 2,250 mg/g body weight, the highest dose tested, based on the lack of mortality observed in all dosage groups. The no observed effect level was lower than 292 mg/kg body weight, the lowest dose tested, based on a slight reduction in body weight at this dosage.

 

In a dietary study, no treatment-related mortality occurred in the Northern Bobwhite (Colinus Virginianus) post exposure to hydrocarbons, C9, aromatics. Sublethal effects (appearance and behaviour) were observed in the 1404 to 6500 ppm concentrations, which began on day 6, or day 1 at the highest dosing level. In each instance, by day 8 till the end of the study for each of these concentrations, all birds were normal in appearance and behaviour. When compared to the controls, there was a slight reduction in body weight gain among birds at 3900 ppm during the exposure period, days 0-5. A reduction in body weight gain was noted among all birds at 6500 ppm during the same time period. There did not appear to be an effect on food consumption at any concentration tested. The no observed effect level was 2340 ppm, based on the signs of toxicity noted at 3900 ppm.

 

The acute toxicity of hydrocarbons, C10, aromatics, >1% naphthalene, as measured by mortality to northern bobwhite (Colinus virginianus) was evaluated both as a single oral dose and in the diet. Under the conditions of these studies, hydrocarbons, C10, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 2250 mg/Kg (oral) or 6500 ppm (diet). The No Observed Effect Levels were 486 mg/Kg, and 842 ppm, respectively.