Registration Dossier
Registration Dossier
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EC number: 402-130-7 | CAS number: 106246-33-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The robust study summary was received from the ECHA in accordance with Article 25(3) (the "12-year-rule"). ECHA helpdesk enquiry number: 06-0000024807-62-0000. The full study report is not available. The test was performed according to Directive 67/548/EEC requirements and GLP.
Data source
Reference
- Reference Type:
- other: Body responsible of the test
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 482 (Unscheduled DNA synthesis)
- GLP compliance:
- yes
- Type of assay:
- other: Unscheduled DNA synthesis, mammalian cells in vitro.
Test material
- Reference substance name:
- -
- EC Number:
- 402-130-7
- EC Name:
- -
- Cas Number:
- 106246-33-7
- Molecular formula:
- C21 H28 Cl2 N2
- IUPAC Name:
- 4-[(4-amino-2-chloro-3,5-diethylphenyl)methyl]-3-chloro-2,6-diethylaniline
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Rat hepatocytes
- Test concentrations with justification for top dose:
- Concentration range in the main test (without metabolic activation): 2...100 µg/ml
- Vehicle / solvent:
- Dimethylsulphoxide (DMSO)
- Details on test system and experimental conditions:
- Exposure period (without metabolic activation): 18 hours
Fixation time: 18 hours
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- see the comments in the box "overall remarks"
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- more than 700 µg/ml
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- see the comments in the box "overall remarks"
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 60 µg/ml
- Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
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.
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