Registration Dossier
Registration Dossier
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EC number: 205-471-8 | CAS number: 141-23-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo insect germ cell study: gene mutation
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a (Q)SAR model, with limited documentation / justification, but validity of model and reliability of prediction considered adequate based on a generally acknowledged source
- Justification for type of information:
- Data is from the Danish (Q)SAR Database, 2017
Data source
Reference
- Reference Type:
- other: Predicted data
- Title:
- Danish QSAR study for CAS No.: 141-23-1
- Author:
- Danish Environmental Protection Agency (DEPA)
- Year:
- 2 017
- Bibliographic source:
- Danish (Q)SAR Database, Division of Diet, Disease Prevention and Toxicology, National Food Institute, Technical University of Denmark, 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: see Principles below
- Principles of method if other than guideline:
- Prediction of genetic toxicity from the Danish (Q)SAR Database
- GLP compliance:
- not specified
- Type of assay:
- Drosophila SLRL assay
Test material
- Reference substance name:
- Methyl 12-hydroxyoctadecanoate
- EC Number:
- 205-471-8
- EC Name:
- Methyl 12-hydroxyoctadecanoate
- Cas Number:
- 141-23-1
- Molecular formula:
- C19H38O3
- IUPAC Name:
- methyl 12-hydroxyoctadecanoate
- Test material form:
- solid
- Details on test material:
- - Name of the test material: Methyl 12-hydroxyoctadecanoate- IUPAC name: Methyl 12-hydroxyoctadecanoate- Molecular formula: C19H38O3- Molecular weight: 314.5062 g/mol- Substance type: Organic- Smiles: C(CCCCCCCCCCC(=O)OC)(CCCCCC)O- Inchl: 1S/C19H38O3/c1-3-4-5-12-15-18(20)16-13-10-8-6-7-9-11-14-17-19(21)22-2/h18,20H,3-17H2,1-2H3
Constituent 1
Test animals
- Species:
- Drosophila melanogaster
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- not specified
- Vehicle:
- No data available
- Details on exposure:
- No data available
- Duration of treatment / exposure:
- No data available
- Frequency of treatment:
- No data available
- Post exposure period:
- No data available
Doses / concentrations
- Remarks:
- Doses/Concentrations: No data available
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Positive control(s):
- No data available
Examinations
- Tissues and cell types examined:
- No data available
- Details of tissue and slide preparation:
- No data available
- Evaluation criteria:
- No data available
- Statistics:
- No data available
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data available
Any other information on results incl. tables
Genetic toxicity was predicted by the Danish QSAR database using the battery approach. The new Danish QSAR database is a repository of model that includes endpoints for physico-chemical properties, environmental fate, bioaccumulation, eco-toxicity, absorption, metabolism and toxicity including genetic toxicity. The end point for genetic toxicity has been modeled in the three software systems Leadscope, CASE Ultra and SciQSAR.
Genetic Toxicity
| Battery | CASE Ultra | Leadscope | SciQSAR | |
Sex-Linked Recessive Lethal (SLRL) Test in Drosophila melanogaster | NEG_IN | NEG_IN | NEG_IN | NEG_IN |
Applicant's summary and conclusion
- Conclusions:
- Genetic toxicity as predicted by Danish QSAR for the target compound was negative for mutagenic effects and hence the chemical is predicted to not classify as a toxic for mutagenicity.
- Executive summary:
Genetic toxicity was predicted for Methyl 12 -hydroxyoctadecanoate using the battery approach from Danish QSAR database (2017). The study assumed Drosophila melanogaster as target organisms and utilized the sex-linked recessive lethal test (SLRL), where the endpoint for genetic toxicity was modeled in the Danish QSAR using the four software systems, i.e. Battery, Leadscope, CASE Ultra and SciQSAR. Genetic toxicity of Methyl 12 -hydroxyoctadecanoate was predicted by Danish QSAR to be negative, and hence the chemical is predicted to not classify as a toxic for mutagenicity.
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