Registration Dossier
Registration Dossier
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EC number: 414-420-0 | CAS number: - SPE 93279
Toxicological information
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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test using the Hprt and xprt genes)
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cell gene mutation (B17)
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- 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): 1000 ... 1700 µg/ml
Concentration range in the main test (without metabolic activation): 1000 ... 1651 µg/ml - Vehicle / solvent:
- Dimethyl sulphoxide
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 3 hours
Exposure period (without metabolic activation): 24 hours
Expression time: Three days
Selection time: Eleven days. - Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 1750 µg/ml)
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 750 µg/ml)
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 1700 µg/ml)
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
There were no significant or dose dependent increases in the mutant frequency in the absence or in the presence of S9 metabolic activation in independent repeat experiments.
In cultures treated with positive control, mutant frequencies increased significantly in all three experiments. - 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 - 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Follows standard guidelines, under GLP
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Ames)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- other: Salmonella typhimurium: TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat-liver S9 mix
- Test concentrations with justification for top dose:
- in the main test (with metabolic activation): 50-5000 µg/plate
in the main test (without metabolic activation): 50-5000 µg/plate - Vehicle / solvent:
- Distilled water
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000µg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Additional information on results:
- No treatment-related increase in the number of revertants was observed
- 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 - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Follows standard guidelines, under GLP
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cytogenicity (B10)
- Species / strain / cell type:
- mammalian cell line, other: Human peripheral lymphocytes stimulated with phytohaemagglutinin
- Metabolic activation:
- with and without
- Metabolic activation system:
- aroclor-induced rat-liver S9 mix
- Test concentrations with justification for top dose:
- in the main test (with metabolic activation): 9.8-5000 µg/ml
in the main test (without metabolic activation): 9.8-5000 µg/ml - Vehicle / solvent:
- distilled water
- Details on test system and experimental conditions:
- exposure period (with metabolic activation): 3h
exposure period (without metabolic activation): 18h
fixation time: 18 and 32h - Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/ml
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1250 µg/ml
- Remarks on result:
- other: other: main test
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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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