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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: This study only reported the effect of a similar substance on offspring eye cataracts, although there is very minimal data on a short exposure to the test substance and its effect on eye cataracts. No other data was reported.

Data source

Reference
Reference Type:
publication
Title:
Observations on cataract formation in the newborn offspring of rats fed a high-galactose diet.
Author:
Segal S and Bernstein H
Year:
1963
Bibliographic source:
J Pediatr, 62:363-370

Materials and methods

Principles of method if other than guideline:
The test substance was fed to pregnant rats during gestation and the occurrence of cataract formation in the pups was examined.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: Not reported

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
Details on mating not reported
Duration of treatment / exposure:
Last 7 days of pregnancy
Frequency of treatment:
Daily
Duration of test:
7 days
Doses / concentrations
Remarks:
Doses / Concentrations:
40%
Basis:
nominal in diet
No. of animals per sex per dose:
3 pregnant females
Control animals:
not specified

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
>= 40 other: % in diet
Based on:
test mat.
Basis for effect level:
other: other:

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No significant cataract formation occurred in any of the litters at 40% xylose in diet.
Executive summary:

A 40% xylose diet was fed to 3 pregnant rats during the last 7 days of pregnancy. No significant cataract formation occurred in any of these litters.