Registration Dossier
Registration Dossier
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EC number: 402-950-5 | CAS number: 87826-41-3 CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A study summary was made available by ECHA under Article 25, Para 3, of EC Regulation 1907/2006.
- Qualifier:
- according to guideline
- Guideline:
- other: Method of B.N.Ames with and without metabolic activation.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- aroclor 1254 induced rat liver microsomal S9 mix.
- Test concentrations with justification for top dose:
- Main test with metabolic activation: 0-500 microgrammes/plate
Main test without metabolic activation: 0-500 microgrammes/plate - Vehicle / solvent:
- Dimethyl sulphoxide (DMSO)
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1500 microgrammes/plate
- Remarks on result:
- other: other: Preliminary test
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Three reliable, GLP compliant, bacterial gene mutation tests are available. The key study (Institut Pasteur de Lille, 1997) employed the full range of bacterial strains recommended in the current OECD 471 test guidelines. The two supporting studies used higher test concentrations, but less robust ranges of bacterial strains. None of the three tests showed any mutagenic activity either with or without metabolic activation.
Justification for selection of genetic toxicity endpoint
Of the three available bacterial gene mutation studies, this was the only one to have employed the full range of bacterial strains recommended in the current OECD 471 test guidelines
Justification for classification or non-classification
The test substance was not classified for mutagenicity, according to EU CLP criteria (Regulation No.1271/2008).
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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