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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:
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.
Qualifier:
according to guideline
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 single dose):
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
Key result
Duration (if not single dose):
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:
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.
Qualifier:
according to guideline
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 single dose):
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 single dose):
5 d
Dose descriptor:
NOEL
Effect level:
842 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
signs of toxicity
Key result
Duration (if not single dose):
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:
read-across from supporting substance (structural analogue or surrogate)
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:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
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 single dose):
14 d
Dose descriptor:
other: LD0
Effect level:
2 250 mg/kg bw
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Key result
Duration (if not single dose):
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
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-C13, 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-C13, 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-C13, 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-C13, 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:
short-term toxicity to birds: dietary toxicity test
Type of information:
read-across from supporting substance (structural analogue or surrogate)
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:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
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 single dose):
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 single dose):
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
Key result
Duration (if not single dose):
5 d
Dose descriptor:
NOEL
Effect level:
842 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
signs of toxicity
Mortality and sub-lethal effects:
No treatment-related mortality occurred. Sublethal effects (appearance and behavior) were observed in the 1404 to 6500 ppm concentration groups, 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-C13, 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-C13, 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-C13, 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-C13, 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:
long-term toxicity to birds
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex X (section 9.6.1), the study does not need to be conducted because based on the lack of toxicity reported in mammalian toxicity testing (see Section 7 Toxicological information), the chemical is not expected to produce toxic effects in birds.

Description of key information

There is data available for this substance. Additionally, key data is available for the structural analogue Hydrocarbons, C10-C13, aromatics, >1% naphthalene. The data for this substance is presented in the dossier. The data is read across to this substance based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Hydrocarbons, C10, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 2250 mg/kg, the highest dosage tested (oral). The No Observed Effect Level was 486 mg/kg, based on the loss of body weight among females at the 810 mg/kg level.

 

Hydrocarbons, C10, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 6500 ppm, the highest dosage tested (diet). The No Observed Effect Level was 842 ppm, based on signs of toxicity noted at the 1404 ppm level.

 

Hydrocarbons, C10-C13, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 2250 mg/kg, the highest dosage tested (gavage). The No Observed Effect Level was 486 mg/kg, based on the loss of body weight among females at the 810 mg/kg level.

 

Hydrocarbons, C10-C13, aromatics, >1% naphthalene did not produce acute lethal toxicity to Colinus virginianus at 6500 ppm, the highest dosage tested (diet). 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

Four study reports were available and input as endpoint records.

The study from Exxon (1992e) examined the toxicity of the test substance Hydrocarbons, C10, aromatics, >1% naphthalene to Colinus virginianus. The test material was administered by oral gavage at concentrations of 0, 292, 486, 810, 1350, and 2250 mg/kg bodyweight to 5 animals per sex per dose (total of 10 animals per dose). The test material did not produce acute lethal toxicity to Colinus virginianus at 2250 mg/kg, the highest dosage tested (oral). 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 study from Exxon (1992f) examined the toxicity of the test substance Hydrocarbons, C10, aromatics, >1% naphthalene to Colinus virginianus. The test material was administered in the diet for 5 days at concentrations of 0, 842, 1404, 2340, 3900, and 6500 ppm (mg/kg feed) to 10 animals per dose. The test material did not produce acute lethal toxicity to Colinus virginianus at 6500 ppm, the highest dosage tested (diet). The No Observed Effect Level was 842 ppm, based on signs of toxicity noted at the 1404 ppm level.

 

The study from Exxon (1992g) examined the toxicity of the test substance Hydrocarbons, C10-C13, aromatics, >1% naphthalene to Colinus virginianus. The test material was administered by oral gavage at concentrations of 0, 292, 486, 810, 1350, and 2250 mg/kg bodyweight to 5 animals per sex per dose (total of 10 animals per dose). The test material did not produce acute lethal toxicity to Colinus virginianus at 2250 mg/kg, the highest dosage tested (gavage). 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 study from Exxon (1992h) examined the toxicity of the test substance Hydrocarbons, C10-C13, aromatics, >1% naphthalene to Colinus virginianus. The test material was administered in the diet for 5 days at concentrations of 0, 842, 1404, 2340, 3900, and 6500 ppm (mg/kg feed) to 10 animals per dose. The test material did not produce acute lethal toxicity to Colinus virginianus at 6500 ppm, the highest dosage tested (diet). The No Observed Effect Level was 842 ppm, based on signs of toxicity noted at the 1404 ppm level.