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Toxicity to birds

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Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Reference:
Composition 0
Qualifier:
according to
Guideline:
EPA OPP 71-2 (Avian Dietary Toxicity Test)
GLP compliance:
yes
Test material information:
Composition 1
Test organisms (species):
Colinus virginianus
Limit test:
no
Total exposure duration (if not bolus):
8 d
No. of animals per sex per dose and/or stage:
5
Nominal and measured doses / concentrations:
562, 1000 ,1780, 3160 & 5620 ppm
Duration (if not bolus):
8 d
Dose descriptor:
LC50
Effect level:
> 5 620 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Duration (if not bolus):
8 d
Dose descriptor:
NOEC
Effect level:
>= 5 620 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
other: external observations of (any) abnormality
Validity criteria fulfilled:
yes
Conclusions:
In conclusion, the LC50 of SY-83 to the bobwhite in this study was greater than 5620 ppm, the highest concentration tested. No apparent treatment related mortalities occurred. The no-observed-effect concentration was 5620 ppm.
Executive summary:

The LC50 of SY-83 to the bobwhite in this study was greater than 5620 ppm, the highest concentration tested. No apparent treatment related mortalities occurred. The no-observed-effect concentration was 5620 ppm.

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
EPA OPP 71-2 (Avian Dietary Toxicity Test)
GLP compliance:
yes
Test material information:
Composition 1
Dose method:
gavage
Analytical monitoring:
no
Test organisms (species):
Anas platyrhynchos
Limit test:
no
Total exposure duration (if not bolus):
8 d
No. of animals per sex per dose and/or stage:
5
Nominal and measured doses / concentrations:
562, 1000, 1780, 3160 & 5620 ppm
Duration (if not bolus):
8 d
Dose descriptor:
LC50
Effect level:
> 5 620 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Duration (if not bolus):
8 d
Dose descriptor:
NOEC
Effect level:
>= 5 620 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
other: any external observation
Conclusions:
In conclusion, the dietary LC50 value of SY-83 to the mallard in this study was greater than 5620 ppm, the highest concentration tested. The no-observed-effect concentration was also 5620 ppm.
Executive summary:

Controls - There were no mortalities in the control group. All birds were normal in appearance and behavior throughout the test period.

SY-83 - There were no signs of toxicity, abnormal behavior or mortality in any test group. All birds were normal in appearance and behavior throughout the test period. When compared to the control, there was no effect on body weight or feed consumption throughout the test period.

The dietary LC50 value of SY-83 to the mallard in this study was greater than 5620 ppm, the highest concentration tested. The no-observed-effect concentration was also 5620 ppm.

Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
EPA OPP 71-1 (Avian Acute Oral Toxicity Test)
GLP compliance:
yes
Test material information:
Composition 1
Dose method:
gavage
Analytical monitoring:
not specified
Vehicle:
yes
Details on preparation and analysis of diet:
DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes
Test organisms (species):
Colinus virginianus
Details on test organisms:
Apparently healthy, pen-reared, mature bobwhite, phenotypically indistinguishable from wild birds, were brought into the laboratory facility, examined for physical injury and acclimated for at least 14 days.
Limit test:
no
Remarks:
Single dose test
Post exposure observation period:
14 days
No. of animals per sex per dose and/or stage:
10 (5 m, 5 f)
Nominal and measured doses / concentrations:
292, 486, 810, 1350 and 2250 milligrams of SY-83 per kilogram of body weight.
Details on test conditions:
ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions (same as test or not): same
- Feeding: ad lib
- Health (any disease or mortality observed): none
- Fasting period before study: 15 h


PEN SIZE AND CONSTRUCTION MATERIALS
The birds were housed indoors during the test period by treatment group in modified Georqia Quail Farm Breeder units (Model No. 0010). Each pen measured approximately 78 X 51 X 23 cm. high and housed five cocks or five hens. External walls,ceilings an dfloors were constructed of galvanized wire grid, while the common walls were constructed of galvanized sheeting.

NO. OF BIRDS PER REPLICATE
- For negative control: 10
- For treated: 10


NO. OF REPLICATES PER GROUP
- For negative control: 1
- For treated: 1


TEST CONDITIONS (range, mean, SD as applicable)
Average temperature for the study was 77°F ± 4°F (SD), with an average relativ ehumidity of 74%. Th ephotoperiod (maintained by a time clock) was eight hours of light per day throughou tth estudy. The birds received approximately twelve footcandles of illumination. The light source was Chroma 50 fluorescent lights which closely approximate noon-day sunlight (noon-day sun - 4870° Keivin, Chroma 50 - 5000° Keivin).
Details on examinations and observations:
All birds were observed daily throughout the study, and a record was maintained of all mortalities and/or signs of toxicity and abnormal behavior. The LD50 value of SY-83 to the bobwhite was determined by inspection.
Body weights were recorded individually at initiation, and by group on Days 3, 7, an da tterminatio no fthe study on Day 14. Feed consumption was measured for Days 0-3, 4-7, and 8-14. Feed consumption was measured accurately but is presented as an estimate due to the unavoidable wastage by the birds.
Reference substance (positive control):
no
Duration (if not bolus):
14 d
Dose descriptor:
LC50
Effect level:
> 2 250 mg/kg bw
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Mortality and sub-lethal effects:
There was an apparent dosage related effect on body weight of males at the 1350 mg/kg and 2250 mg/kg dosages for Days 0-3. There appeared to be no effect on feed consumption at any dosage.
Further details on results:
In conclusion, the acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no- observed-effect dosage was 810 mg/kg.
Validity criteria fulfilled:
yes
Conclusions:
In conclusion, the acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no- observed-effect dosage was 810 mg/kg.
Executive summary:

The acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no- observed-effect dosage was 810 mg/kg. Since lactic acid is an essential molecule for life and has an extensive role in metabolism, this may be just a result of an equilibrium shift in metabolic pathways.

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
This information is used in a read-across approach in the assessment of the target substance.

Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
EPA OPP 71-2 (Avian Dietary Toxicity Test)
GLP compliance:
yes
Test material information:
Composition 1
Test organisms (species):
Colinus virginianus
Limit test:
no
Total exposure duration (if not bolus):
8 d
No. of animals per sex per dose and/or stage:
5
Nominal and measured doses / concentrations:
562, 1000 ,1780, 3160 & 5620 ppm
Duration (if not bolus):
8 d
Dose descriptor:
LC50
Effect level:
> 5 620 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Duration (if not bolus):
8 d
Dose descriptor:
NOEC
Effect level:
>= 5 620 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
other: external observations of (any) abnormality
Validity criteria fulfilled:
yes
Conclusions:
In conclusion, the LC50 of SY-83 to the bobwhite in this study was greater than 5620 ppm, the highest concentration tested. No apparent treatment related mortalities occurred. The no-observed-effect concentration was 5620 ppm.
Executive summary:

The LC50 of SY-83 to the bobwhite in this study was greater than 5620 ppm, the highest concentration tested. No apparent treatment related mortalities occurred. The no-observed-effect concentration was 5620 ppm.

This information is used in a read-across approach in the assessment of the target substance.

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

Endpoint:
short-term toxicity to birds: dietary toxicity test
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
This information is used in a read-across approach in the assessment of the target substance.

Reason / purpose:
read-across source
Related information:
Composition 1
Qualifier:
according to
Guideline:
EPA OPP 71-2 (Avian Dietary Toxicity Test)
GLP compliance:
yes
Test material information:
Composition 1
Dose method:
gavage
Analytical monitoring:
no
Test organisms (species):
Anas platyrhynchos
Limit test:
no
Total exposure duration (if not bolus):
8 d
No. of animals per sex per dose and/or stage:
5
Nominal and measured doses / concentrations:
562, 1000, 1780, 3160 & 5620 ppm
Duration (if not bolus):
8 d
Dose descriptor:
LC50
Effect level:
> 5 620 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Duration (if not bolus):
8 d
Dose descriptor:
NOEC
Effect level:
>= 5 620 mg/kg diet
Conc. / dose based on:
test mat.
Basis for effect:
other: any external observation
Conclusions:
In conclusion, the dietary LC50 value of SY-83 to the mallard in this study was greater than 5620 ppm, the highest concentration tested. The no-observed-effect concentration was also 5620 ppm.
Executive summary:

Controls - There were no mortalities in the control group. All birds were normal in appearance and behavior throughout the test period.

SY-83 - There were no signs of toxicity, abnormal behavior or mortality in any test group. All birds were normal in appearance and behavior throughout the test period. When compared to the control, there was no effect on body weight or feed consumption throughout the test period.

The dietary LC50 value of SY-83 to the mallard in this study was greater than 5620 ppm, the highest concentration tested. The no-observed-effect concentration was also 5620 ppm.

This information is used in a read-across approach in the assessment of the target substance.

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

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:
weight of evidence
Justification for type of information:
This information is used in a read-across approach in the assessment of the target substance.
Reason / purpose:
read-across source
Related information:
Composition 1
Qualifier:
according to
Guideline:
EPA OPP 71-1 (Avian Acute Oral Toxicity Test)
GLP compliance:
yes
Test material information:
Composition 1
Dose method:
gavage
Analytical monitoring:
not specified
Vehicle:
yes
Details on preparation and analysis of diet:
DIET PREPARATION
- Description and nutrient analysis of basal diet provided in study report: yes
Test organisms (species):
Colinus virginianus
Details on test organisms:
Apparently healthy, pen-reared, mature bobwhite, phenotypically indistinguishable from wild birds, were brought into the laboratory facility, examined for physical injury and acclimated for at least 14 days.
Limit test:
no
Remarks:
Single dose test
Post exposure observation period:
14 days
No. of animals per sex per dose and/or stage:
10 (5 m, 5 f)
Nominal and measured doses / concentrations:
292, 486, 810, 1350 and 2250 milligrams of SY-83 per kilogram of body weight.
Details on test conditions:
ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions (same as test or not): same
- Feeding: ad lib
- Health (any disease or mortality observed): none
- Fasting period before study: 15 h


PEN SIZE AND CONSTRUCTION MATERIALS
The birds were housed indoors during the test period by treatment group in modified Georqia Quail Farm Breeder units (Model No. 0010). Each pen measured approximately 78 X 51 X 23 cm. high and housed five cocks or five hens. External walls,ceilings an dfloors were constructed of galvanized wire grid, while the common walls were constructed of galvanized sheeting.

NO. OF BIRDS PER REPLICATE
- For negative control: 10
- For treated: 10


NO. OF REPLICATES PER GROUP
- For negative control: 1
- For treated: 1


TEST CONDITIONS (range, mean, SD as applicable)
Average temperature for the study was 77°F ± 4°F (SD), with an average relativ ehumidity of 74%. Th ephotoperiod (maintained by a time clock) was eight hours of light per day throughou tth estudy. The birds received approximately twelve footcandles of illumination. The light source was Chroma 50 fluorescent lights which closely approximate noon-day sunlight (noon-day sun - 4870° Keivin, Chroma 50 - 5000° Keivin).
Details on examinations and observations:
All birds were observed daily throughout the study, and a record was maintained of all mortalities and/or signs of toxicity and abnormal behavior. The LD50 value of SY-83 to the bobwhite was determined by inspection.
Body weights were recorded individually at initiation, and by group on Days 3, 7, an da tterminatio no fthe study on Day 14. Feed consumption was measured for Days 0-3, 4-7, and 8-14. Feed consumption was measured accurately but is presented as an estimate due to the unavoidable wastage by the birds.
Reference substance (positive control):
no
Duration (if not bolus):
14 d
Dose descriptor:
LC50
Effect level:
> 2 250 mg/kg bw
Conc. / dose based on:
test mat.
Basis for effect:
mortality
Mortality and sub-lethal effects:
There was an apparent dosage related effect on body weight of males at the 1350 mg/kg and 2250 mg/kg dosages for Days 0-3. There appeared to be no effect on feed consumption at any dosage.
Further details on results:
In conclusion, the acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no- observed-effect dosage was 810 mg/kg.
Validity criteria fulfilled:
yes
Conclusions:
In conclusion, the acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no- observed-effect dosage was 810 mg/kg.
Executive summary:

The acute oral LD50 value of SY-83 to the bobwhite for this study was determined to be greater than 2250 mg/kg, the highest dosage tested. There were no mortalities at any dosage tested. Based upon effects on male body weight at 1350 and 2250 mg/kg, the no- observed-effect dosage was 810 mg/kg. Since lactic acid is an essential molecule for life and has an extensive role in metabolism, this may be just a result of an equilibrium shift in metabolic pathways.

This information is used in a read-across approach in the assessment of the target substance.

For details and justification of read-across please refer to the attached report in section 13 of IUCLID.

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

In view of the general lack of systemic toxicity of lactic acid, being an endogenous metabolite both in mammals and birds, a test of reproductive toxicity in birds is not considered to be required. Nevertheless, available studies on L(+) Lactic acid are used for read-across to evaluate the toxicity to birds.

In all three studies the substance seems not be toxic to birds:

LD50 > 2250 mg/kg (highest dosage tested)

no mortalities NOEC (male weight) = 810 mg/kg

LC50 > 5620 ppm (highest dosage tested); no mortalities occured

NOEC = 5620 ppm

Key value for chemical safety assessment

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

Additional information