Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 810-464-3 | CAS number: 13446-84-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-09-17 ~ 2015-12-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2'-[cyclohexane-1,1-diylbis(4,1-phenyleneoxymethylene)]dioxirane
- Cas Number:
- 13446-84-9
- Molecular formula:
- C24H28O4
- IUPAC Name:
- 2,2'-[cyclohexane-1,1-diylbis(4,1-phenyleneoxymethylene)]dioxirane
- Test material form:
- liquid: viscous
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Without S9 mix:
313, 625, 1250, 2500, 5000 μg/plate (TA98, TA100, TA1535, TA1537, WP2uvrA)
With S9 mix:
313, 625, 1250, 2500, 5000 μg/plate (TA98, WP2uvrA)
23.4, 46.9, 93.8, 187.5, 375, 750, 1500 μg/plate (TA100)
7.8, 15.6, 31.3, 62.5, 125, 250, 500 μg/plate (TA1535, TA1537)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the concentration range-finding test, the highest doses in main test was conducted 50, 150, 500, 1500 and 5000 μg/plate. The number of revertant colonies was more than twice that in the corresponding negative (vehicle) control in TA100 strain of the absence of S9 mix. The reproducibility of the test results was confirmed with the concentration range-finding test and main test.
The numbers of revertant colonies in the negative (vehicle) control and positive control groups in the present study were within the acceptable ranges stipulated at the testing facility (appendix). The positive controls used in the assays with the presence or absence of S9 mix showed positive responses by the respective test strains, as evidenced by the number of revertant colonies being greater than 2-fold of the respective negative (vehicle) control value. In each test, there were 4 or more doses giving no microbial toxicity and at least 5 analyzable doses for all strains in the presence and absence of S9 mix. Consequently, the validity of the present study was confirmed.
Therefore, it was concluded that SEZ-250 was mutagenic (positive) under the conditions employed in the present study.
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.
