Registration Dossier
Registration Dossier
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EC number: 251-459-0 | CAS number: 33329-35-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed in accordance with OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay). A GLP certificate is provided.
- Justification for type of information:
- see attached justification
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- The stability of the test substance in the vehicle water has not been determined analytically .
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine
- EC Number:
- 223-362-3
- EC Name:
- N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine
- Cas Number:
- 3855-32-1
- Molecular formula:
- C11H27N3
- IUPAC Name:
- N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine
- Test material form:
- solid - liquid: suspension
Constituent 1
Method
- Target gene:
- TA. 1535, TA 100, TA 1537, TA 98 and E . coli WP2 uvrA
- Test concentrations with justification for top dose:
- 20 - 5,000 ug/plate
- Details on test system and experimental conditions:
- Standard plate test and preincubation test both with and without metabolic activation (Aroclor-induced rat liver S-9 mix)
Results and discussion
Test results
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No precitation of the test sub stance was found.
Occasionally, a slight decrease in the number of revertants was observed in the standard plate test with S-9 mix at 5,000 ug/ plate . In the preincubation assay bacteriotoxicity was found depending on the strain and test conditions_at doses > 2,500 ug / plate - 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
According to the result's of the present study, the substance is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the experimental condition chosen.
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