Registration Dossier
Registration Dossier
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EC number: 205-737-3 | CAS number: 149-32-6
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Original publication (Gallandre, 1978) not available: reviewed data in reliable Joint FAO/WHO Expert Committee on Food Additives (JECFA) report
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- WHO FOOD ADDITIVES SERIES NO. 13 - INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY, WORLD HEALTH ORGANIZATION, SUMMARY OF TOXICOLOGICAL DATA OF CERTAIN FOOD ADDITIVES AND CONTAMINANTS,
- Author:
- Joint FAO/WHO Expert Committee on Food Additives (JECFA)
- Year:
- 1 978
- Bibliographic source:
- INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY, WORLD HEALTH ORGANIZATION, SUMMARY OF TOXICOLOGICAL DATA OF CERTAIN FOOD ADDITIVES AND CONTAMINANTS,
- Report date:
- 1978
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- micronucleus test with Fullinsdorf albino mice
- Deviations:
- not specified
- Principles of method if other than guideline:
- micronucleus test with Fullinsdorf albino mice
- GLP compliance:
- not specified
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Xylitol
- EC Number:
- 201-788-0
- EC Name:
- Xylitol
- Cas Number:
- 87-99-0
- Molecular formula:
- C5H12O5
- IUPAC Name:
- D-erythro-pentitol
Constituent 1
- Specific details on test material used for the study:
- purity not specified
Test animals
- Species:
- mouse
- Strain:
- other: Fullinsdorf albino mice
Results and discussion
Test results
- Key result
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- According to Gallandre F. (and as reported by JECFA), Xylitol caused no observable mutagenic effects in the system studied
- Executive summary:
According to Gallandre F. (and as reported by JECFA), Xylitol caused no observable mutagenic effects in the system studied
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