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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
Toxicological information
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:
- 03.08.2010 - 13.08.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- EU B.13/14
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, rfa.
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: hisG428, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: hisD3052, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- other: hisD6610, uvrB, pKM 101, rfa
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 was obtained by Trinova Biochem, Gießen. Batch no: 2572.
Specification: produced from the lievers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight intraperitoneally. - Test concentrations with justification for top dose:
- First Experiment:
5042 / 1513 / 504 / 151 / 50 µg/plate
Second Experiment:
4891 / 2491 / 1246 / 623 / 312 µg/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine, CAS-No.: 99-56-9
- Remarks:
- 20 μg/plate, DMSO, Strains TA97a, TA98 and TA102, Metabolic activation: none
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Positive control substance:
- other: 2-Amino-anthracene, CAS-No. 613-13-8
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Details on test system and experimental conditions:
- First Experiment:
Concentrations tested: 5042 / 1513 / 504 / 151 / 50 µg/plate
Incubation time: 48 hours
Incubation temperature: 37 °C
Tester strains: TA97a, TA98, TA100, TA102, TA1535
Method: plate incorporation method
Second Experiment
Concentrations tested: 4987 / 2491 / 1246 / 623 / 312 µg/plate
Incubation time: 48 hours
Incubation temperature: 37 °C
Tester strains: TA97a, TA98, TA100, TA102, TA1535
Method: pre-incubation method
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Two valid experiments were perfomed.
First Experiment:
Five concentrations of the test item, dissolved in DMSO were used: Five genetically manipulated strains of Salmonella typhimurium (TA 97a, TA 98, TA100, TA102 and TA 1535) were exposed to the test item both in the presence and in the absence of a metabolic activation system (S9) for 48 hours, using the plate incorporation method.
None of the concentrations caused a significant increase in the number of revertant colonies in the tested strains. The test item didn't show any mutagenic effects in the first experiment.
No signs of toxicity towards the bacteria could be observed.
The sterility control and the determination of the titre didn't show any inconsistencies. The determined values for the spontanous revertants of the negative controls were in the normal range. All positive controls showed mutangenic effects with and withour metabolic activation.
Second Experiment:
To verify the results of the first experiment, a second experiment was performed, using five concentrations of the test item (ranging from 4981 to 312 µg/plate) and a modification in study performance (pre-incubation method).
The test item didn't show mutagenic effects in the second experiment, either.
No signs of toxicity towards the bacteria could be observed.
The sterility control and the determination of the titre didn't show any inconsistncies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Under the conditions of the test, the test item didn't show mutagenic effects towards Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535
Terefore, no concentration-effect relationship could be determined.
The test item Dicyclohexylammonium Isostearat (Isostaric acid, compund with Dicyclohexylamine) is considered as "not mutagenic under the conditions of the test".
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.
