Registration Dossier
Registration Dossier
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EC number: 200-400-7 | CAS number: 58-86-6
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- 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:
- 1 963
- 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 substance name:
- Xylose
- EC Number:
- 200-400-7
- EC Name:
- Xylose
- Cas Number:
- 58-86-6
- Molecular formula:
- C5H10O5
- IUPAC Name:
- (2S,3R,4S; 5R)-oxane-2,3,4,5-tetrol
- Details on test material:
- - Purity: Not reported
Constituent 1
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
- 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.
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