Registration Dossier
Registration Dossier
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EC number: 423-300-7 | CAS number: 128554-52-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 423-300-7
- EC Name:
- -
- Cas Number:
- 128554-52-9
- Molecular formula:
- Molecular formula varies for each reaction product. See section 1.2 for the molecular formula for each identified reaction product.
- IUPAC Name:
- 12-hydroxy-N-({3-[(12-hydroxyoctadecanamido)methyl]phenyl}methyl)octadecanamide
- Reference substance name:
- AMIDE#71
- IUPAC Name:
- AMIDE#71
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: AMIDE#71
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S90 homogenate
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 3 - 333 µg/plate
Concentration range in the main test (without metabolic activation): 3 - 333 µg/plate - Vehicle / solvent:
- Solvent: DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DETERMINATION OF CYTOTOXICITY
- Method: plates were assessed for numbers of revertant colonies and examined for effects on the growth of the bacterial background lawn.
OTHER
- Concentration of the test substance resulting in precipitation: 333 µg/plate
Results and discussion
Test resultsopen allclose all
- 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:
- cytotoxicity
- Remarks:
- >5000 µg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- 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:
- cytotoxicity
- Remarks:
- >333 µg/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Concentration of the test substance resulting in precipitation: 333 µg/plate - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test substance was considered to be non-mutagenic under the conditions of the test.
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