Registration Dossier
Registration Dossier
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EC number: 405-370-0 | CAS number: 6334-25-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study already evaluated and accepted by national autorities. Information from migrated NONS file as per inquiry # [06-0000014662-72-00000].
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cell gene mutation (B17)
Test material
- Reference substance name:
- -
- EC Number:
- 405-370-0
- EC Name:
- -
- Cas Number:
- 6334-25-4
- Molecular formula:
- C14H28N2O6
- IUPAC Name:
- N,N,N',N',-tetrakis(2-hydroxyethyl)hexanediamide
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 625...5000 micrograms/ml
Concentration range in the main test (without metabolic activation): 625...5000 micrograms/ml - Vehicle / solvent:
- Distilled water
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 18 hours
Fixation time:
6th amendment fixation time: 18
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Observations:
Positiva control substances gave appropriate responses - 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 with metabolic activation
negative without metabolic activation
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