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EC number: 201-788-0 | CAS number: 87-99-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- 3 strains of bacterial used
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Xylitol
- EC Number:
- 201-788-0
- EC Name:
- Xylitol
- Cas Number:
- 87-99-0
- Molecular formula:
- C5H12O5
- IUPAC Name:
- (2R,3r,4S)-pentane-1,2,3,4,5-pentol
- Details on test material:
- - Purity: not reported
Constituent 1
Method
- Target gene:
- histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9
- Test concentrations with justification for top dose:
- 0, 15.6, 31.25, 62.5 and 125 mg/plate
- Vehicle / solvent:
- dissolved in phosphate buffered saline
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS: 4
- Statistics:
- The statistical analysis according to KAPLAN has previously been described.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Only in the first experiment, with the highest dose of the compound added to the bacteria and only after metabolic activation a significant (p< 0.01), about twofold increase of the revertants above background could be observed with Salmonella typhimurium TA 1538. As usually in the AMES test only three times more revertant colonies as compared to the background are considered to be a positive result and as this observation could not be reproduced, the authors do not think this finding to be of great relevance. Moreover, even in an experiment with 10 plates per dosage group the result could not be reproduced, while with the positive control 3-MCA a 15-fold increase of the revertant colonies above background could be observed.
Applicant's summary and conclusion
- Conclusions:
- Ames test is negative.
- Executive summary:
The Ames test with Salmonella typhimurium TA 1535, TA 1537 and TA 1538 was carried out to assess the potential mutagenic activity of the test substance. Only in the first experiment, with the highest dose of the compound added to the bacteria and only after metabolic activation a significant (p< 0.01), about twofold increase of the revertants above background could be observed with Salmonella typhimurium TA 1538. Although this increase is statistically significant, it is very likely to be an artefact due to the biological variation of the system, as the effect could not be reproduced in further experiments and as usually only a threefold increase of revertant colonies above background or more is considered to be positive. Neither the test substance nor one of its metabolites formed by a rat liver microsomal fraction was able to induce gene mutations.
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