Registration Dossier
Registration Dossier
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EC number: 406-690-3 | CAS number: 43136-14-7 MDI/ODA
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
- Study period:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Ames)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
- EC Number:
- 406-690-3
- EC Name:
- 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
- Cas Number:
- 43136-14-7
- Molecular formula:
- C51H88N4O2
- IUPAC Name:
- 3-octadecyl-1-[4-({4-[(octadecylcarbamoyl)amino]phenyl}methyl)phenyl]urea
- Test material form:
- other: No data available, ECHA provided study summaries migrated from the SNIF format.
- Details on test material:
- No data available, ECHA provided study summaries migrated from the SNIF format.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 10 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 10 ... 5000 μg/plate - Vehicle / solvent:
- Solvent: Dimethylsulfoxide
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 μg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Species / strain:
- other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- No toxicity at up to 5000 μg/plate
- Vehicle controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- Untreated negative controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- True negative controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- Positive controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- No toxicity at up to 5000 μg/plate
- Vehicle controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- Untreated negative controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- True negative controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- Positive controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 μg/plate
- Vehicle controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Untreated negative controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- True negative controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Positive controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Vehicle controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Untreated negative controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- True negative controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Positive controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Vehicle controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Untreated negative controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- True negative controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Positive controls validity:
- not specified
- Remarks:
- No data available, ECHA provided study summaries migrated from the SNIF format
- Additional information on results:
- Observations:
No increase in revertants was observed at any dose
Any other information on results incl. tables
Comments: Toxic concentration in preliminary test: with metabolic activation:
No toxicity observed up to 5000 micrograms/plate (TA98, TA 100) without metabolic activation:
No toxicity observed up to 5000 micrograms/plate (TA98, TA 100)
Toxic concentration in main test:
with metabolic activation: 5000 micrograms/plate for TA1538 (in one experiment only)
without metabolic activation: 5000 micrograms/plate for TA1538 (in one experiment only)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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