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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-610-1 | CAS number: 68131-13-5
Genetic toxicity: in vitro
Administrative data
- 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
- Study period:
- March 10 - July 27, 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Naphthenic acids, reaction products with diethylenetriamine
- EC Number:
- 268-610-1
- EC Name:
- Naphthenic acids, reaction products with diethylenetriamine
- Cas Number:
- 68131-13-5
- Molecular formula:
- C16H21N3O2 (minimal)
- IUPAC Name:
- Naphthenic acids, reaction products with diethylenetriamine
- Details on test material:
- product name: MK195KSF
Sample description: orange/brown hazy solid
Volatile: no
Density: 0.83
pH: 9.07
Storage conditions: at room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Experiment I:
without metabolic activation:
1, 2, 4, 6, 8 and 10 μg/mL
with metabolic activation:
8, 10, 20, 40, 60, 80 and 100 μg/mL
Experiment II:
without metabolic activation:
0.031, 0.063, 0.125, 0.25, 0.5, 1, 2 and 4 μg/mL
with metabolic activation:
10, 20, 30, 40, 50 and 60 μg/mL
Controls
- Untreated negative controls:
- yes
- Remarks:
- cell culture medium (DMSO)
- Positive controls:
- yes
- Remarks:
- Without metabolic activation: EMS; Ethylmethanesulfonate. With metabolic activation: CPA; Cyclophosphamide
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In experiment I at 4ug/mL without S9 and at 40ug/mL with S9. In experiment II at >= 0.5ug/mL without S9 and at >= 50ug/mL with S9.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, it can be stated that during the described in vitro chromosomal aberration test and under the experimental conditions reported, the test item MK195KSF-Naphthenic acids, reaction products with diethylenetriamine did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line.
Therefore, the test item MK195KSF-Naphthenic acids, reaction products with diethylenetriamine is considered to be non-clastogenic.
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.
