Registration Dossier
Registration Dossier
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EC number: 208-874-7 | CAS number: 544-62-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Batilol
- EC Number:
- 208-874-7
- EC Name:
- Batilol
- Cas Number:
- 544-62-7
- Molecular formula:
- C21H44O3
- IUPAC Name:
- 3-(octadecyloxy)propane-1,2-diol
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- uvrB
Species / strain
- Species / strain / cell type:
- other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 1; 1.5; 2 and 2.5mg/ml of DMSO
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: for strain TA97a, without metabolic activation: ICR 191; for strain TA98, without metabolic activation: 2,4,7-trinitro-9-fluorénone
Results and discussion
Test results
- Species / strain:
- other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Executive summary:
The substance wasn't genotoxic in an AMES test (OECD 471) on the strains TA97a, TA98, TA100, TA102, TA1535, with and without metabolica activation.
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