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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 605-301-6 | CAS number: 162691-59-0
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
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 471. Study conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Asta-C15-Acetal (C15-Acl)
- IUPAC Name:
- Asta-C15-Acetal (C15-Acl)
- Reference substance name:
- 94/29
- IUPAC Name:
- 94/29
- Details on test material:
- - NAME OF TEST SUBSTANCE: ASTA-C15-ACETAL (C15-ACL)
- SUBSTANCE NUMBER: 94/29
- LOT NUMBER: 25656/133 S
- DATE OF MANUFACTURING: 07-FEB-1994
- PHYSICAL STATE/APPEARANCE: LIQUID, OILY, YELLOW
- STORAGE CONDITIONS: ROOM TEMPERATURE, EXCLUSION OF LIGHT
Constituent 1
Constituent 2
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S-9 fractions.
- Test concentrations with justification for top dose:
- 20; 100; 500; 2,500; 5,000 ug/plate
- Vehicle / solvent:
- DMSO
- Details on test system and experimental conditions:
- Tester strains, doses, number of plates
1st Experiment:
- Strains: TA 1535, TA 100, TA 1537, TA 98
- Doses: 0, 20, 100, 500, 2500 and 5000 ug/plate
- Vehicle: DMSO
- Type of test test conditions: standard plate test with and withtout S-9 mix
- Number of plates: 3 test plates per dose or per control
2nd Experiment:
- Strains: TA 1535, TA 100, TA 1537, TA 98
- Doses: 0, 20, 100, 500, 2500 and 5000 ug/plate
- Vehicle: DMSO
- Type of test, test conditions: preincubation test with and without S-9 mix
- Number of plates: 3 test plates per dose or per control - Evaluation criteria:
- In general, a substance to be characterized as positive in the AMES test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- close-response relationship
- reproducibility of the results.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Bacteriotoxicity observed in the standard plate test with TA 1537 at 5,000 ug/plate (+/- S-9 mix) and TA 100 at doses >= 500 ug/plate (only + S-9 mix).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- According to the results of the present study, the test substance Asta-C15-Acetal (C15-Acl) is not mutagenic in the AMES Test under the experimental conditions chosen here.
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.
