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Ecotoxicological information

Toxicity to birds

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Administrative data

Endpoint:
short-term toxicity to birds: acute oral toxicity test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline compliant GLP study. Since dilactide undergoes immediate hydrolysis in contact with water or gastric juice, forming lactic acid, this is the moiety of interest by read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 71-1 (Avian Acute Oral Toxicity Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SY-83
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

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.

Study design

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).

Examinations

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

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.