Registration Dossier
Registration Dossier
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EC number: 208-173-6 | CAS number: 513-85-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- genetic toxicity in vitro
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline study conducted according GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
- Principles of method if other than guideline:
- Method: other: according Gee et al. Mut res 412, 115ff. (1998)
- GLP compliance:
- yes
- Type of assay:
- other: Ames-II Assay
Test material
- Reference substance name:
- Butane-2,3-diol
- EC Number:
- 208-173-6
- EC Name:
- Butane-2,3-diol
- Cas Number:
- 513-85-9
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-2,3-diol
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 98 and TAmix (TA7001-7006)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 4-5000 ug/ml
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 98, TA Mix (TA7001-7006)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Salmonella typhimurium TA 98 and TA Mix (TA7001-7006)
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- According to the results of the present study, the test substance 2,3-Butandiol is not mutagenic in the Ames II Assay (Salmonella typhimurium reverse mutation assay) under the experimental conditions chosen.
- Executive summary:
According to the results of the present study, the test substance did not lead to an increase in the number of revertant wells either without S-9 mix or after adding a metabolizing system .
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