Registration Dossier
Registration Dossier
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EC number: 209-527-2 | CAS number: 584-03-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- 1,2-BUTANEDIOL CAS No: 584-03-2
- Author:
- OECD
- Year:
- 2 002
- Bibliographic source:
- SIDS publication - Vol.1 Part 2
- Reference Type:
- review article or handbook
- Title:
- Safety assessment of 1,2-glycols as used in cosmetics
- Author:
- Johnson W Jr et al.
- Year:
- 2 012
- Bibliographic source:
- Int J Toxicol. 2012 Sep-Oct;31(5 Suppl):147S-68S.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes
Test material
- Reference substance name:
- Butane-1,2-diol
- EC Number:
- 209-527-2
- EC Name:
- Butane-1,2-diol
- Cas Number:
- 584-03-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,2-diol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Dose / Concentration: 312.5-5000 µg/ plate.
- Vehicle / solvent:
- DMSO
- Details on test system and experimental conditions:
- Exposure comments:
Doses of: 0, 312.5, 625, 1250, 2500 or 5000 micrograms of 1,2-butanediol were applied per plate in 3 plates.
Positive control:
A) S9 negative received AF-2 sodium azide or 9-aminoacridine
B) S9 positive received 2-aminoanthracene. S9 activated by phenobarbital and 5,6-benzoflavone.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
Any other information on results incl. tables
Minimum concentration of test substance at which toxicity to bacteria was observed is > 5000ug/plate with metabolic activation and 5000ug/plate without metabolic activation.
In all strains at all concentrations tested, with or without metabolic activation, the test substance did not induce any changes within the chromosomal chromatin.
Applicant's summary and conclusion
- Executive summary:
CAS 584-03-2 was considered as "negative" in gene mutation tests under the experimental conditions used.
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