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Toxicological information

Genetic toxicity: in vivo

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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:
1978
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:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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 valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
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