Registration Dossier
Registration Dossier
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EC number: 445-510-8 | CAS number: -
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)
Data source
Reference
- Reference Type:
- other:
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V, Method B.13/14 - OECD n.471 Bacterial reverse Mutation test
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 445-510-8
- EC Name:
- -
- Molecular formula:
- C26H32O4
- IUPAC Name:
- Reaction mass of 2-hydroxy-1-{3-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,1,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one and 2-hydroxy-1-{1-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,3,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA 1537, TA 98, TA 1535, TA 100- Eschrichia coli WP2 uvrA
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): >= 33 ... <= 5000 μg/plate
Concentration range in the main test (without metabolic activation): >= 33 ... <= 5000 μg/plate - Vehicle / solvent:
- Solvent: DMSO
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 μg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Vehicle controls validity:
- other: not available
- Untreated negative controls validity:
- other: not available
- Positive controls validity:
- other: not available
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Vehicle controls validity:
- other: not available
- Untreated negative controls validity:
- other: not available
- Positive controls validity:
- other: not available
- Species / strain:
- other:
- Remarks:
- as specified above
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Vehicle controls validity:
- other: not available
- Untreated negative controls validity:
- other: not available
- Positive controls validity:
- other: not available
- Remarks on result:
- other: not available
Any other information on results incl. tables
Observations: No substancial increase in revertant colony numbers of any of five tester strainswas observed following treatment with product at any dose level 33,100,333, 1000, 2500 and 5000 ug/plate
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
