Registration Dossier
Registration Dossier
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EC number: 812-490-0 | CAS number: 1312943-21-7
Genetic toxicity: in vitro
Some information in this page has been claimed confidential.
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:
- guideline study without detailed documentation
- Remarks:
- This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.
Data source
Reference
- Reference Type:
- other: Body responsilble for test
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Ames)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- and TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 10 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 10 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Dimethylsulfoxide
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-ortho-ohenylenediamine and 2-aminoanthracene
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 333 µg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Strains as specified above, preliminary test
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 µg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- primary culture, other: Strains as specified above, preliminary test
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- other: Strains as specified above, main test
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- other: Strains as specified above, main test
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 µg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Observations: The plates incubated with the test substance showed normal background growth at concentrations up to 5000 µg/plate. No increases in the numbers of revertant colonies were seen at any of the concentrations of the test substance with or without metabolic activation.
Positive control substances sodium azide, 4-nitro-ortho-ohenylenediamine) and 2-aminoanthracene led to increases in induce revertant colonies in the appropriate bacterial strains.
Applicant's summary and conclusion
- Conclusions:
- The Ames test was negative with metabolic activation and without metabolic activation.
- Executive summary:
The test item was investigated for in vitro genetic toxicity at the concentration in an Ames test with a concentration range of 10 to 5000 µg/plate, with and without metabolic activation, following a standard guideline. The study included TA98, TA100, TA1535, TA1537 and TA1538 strains. Positive control substances were also included. The Ames test was negative with metabolic activation and negative without metabolic activation as no increases in the numbers of revertant colonies were seen at any of the concentrations of the test substance, with or without metabolic activation.
The study is a GLP compliant, guideline study and is acceptable with restrictions for assessment of this endpoint.
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