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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Various dosages of Sodium Erythorbate were administered via gastric intubation to mated female albino CD-1 outbred mice on days 6-15 of gestation. The test volume was 10ml/kg in water. The positive control was 150mg/kg of aspirin. Body weights were recorded on days 0, 6, 11, 15, and 17 of gestation. The mice were observed for apperance and behavior, as well as feed consumption.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
mouse
Strain:
CD-1

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
10.3
Basis:
nominal in water
Remarks:
Doses / Concentrations:
47.8
Basis:
nominal in water
Remarks:
Doses / Concentrations:
221.9
Basis:
nominal in water
Remarks:
Doses / Concentrations:
1030
Basis:
nominal in water
No. of animals per sex per dose:
21
Control animals:
yes

Examinations

Maternal examinations:
All control and test mice survived to term. Of the nagative control mice, 21 of 30 became pregnant. Tweny-one of 23 mice of the positive control
group were pregnant.
Fetal examinations:
Average fetus weight doesn't change. Live fetuses examined at term. The number of abnormalities seen in either soft or skeletal tissues of the test
groups did not differ from the number occurring spontaneously in the sham-treated controls.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
> 1 030 mg/kg bw/day (nominal)
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion