Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 413-110-2 | CAS number: 135861-56-2
Genetic toxicity: in vitro
Administrative data
- 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:
- other: All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum.
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 413-110-2
- EC Name:
- -
- Cas Number:
- 135861-56-2
- Molecular formula:
- C24H30O6
- IUPAC Name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Details on test material:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Constituent 1
Method
- Target gene:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA 1538 and Escherichia coli WP2uvrA-
- Metabolic activation system:
- S9mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 100....5000 µg/plate
Concentration range in the main test (without metabolic activation): 100.......5000 µg/plate - Vehicle / solvent:
- solvent(s) used: Dimethylsulphoxide (DMSO)
Controls
- Untreated negative controls:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Negative solvent / vehicle controls:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- True negative controls:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Positive controls:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Positive control substance:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 1000 µg/plate
- Evaluation criteria:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Statistics:
- This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 µg/plate
- Vehicle controls validity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Untreated negative controls validity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Positive controls validity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 µg/plate
- Vehicle controls validity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Untreated negative controls validity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Positive controls validity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 µg/plate
- Vehicle controls validity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Untreated negative controls validity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- Positive controls validity:
- other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
- 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 with metabolic activation
negative without metabolic activation
The test material was negative for genetic mutation, with and without metabolic activation, in an Ames study. - Executive summary:
All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant.
Genetic mutation (in vitro) was examined by using OECD Guideline 401 (1981) Annex V - Method B14
T-1540N was demonstrated to be negative for genetic mutation, with and 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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