Registration Dossier
Registration Dossier
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EC number: 432-130-2 | CAS number: 119345-01-6
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:
- Not specified
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 432-130-2
- EC Name:
- -
- Cas Number:
- 119345-01-6
- Molecular formula:
- Not applicable ( a generic molecular formula cannot be provided for this UVCB substance)
- IUPAC Name:
- Reaction products of phosphorous trichloride, with 1,1′-biphenyl and 2,4-bis(1,1-dimethylethyl)phenol
- Details on test material:
- No data
Constituent 1
Method
- Target gene:
- No data
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- ESSAII & II: rat liver S9 fractions treated with phenobarbital / β-naphthoflavone
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 33 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 33 ... 5000 μg/plate - Vehicle / solvent:
- Solvent: Acetone
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- No data
- Evaluation criteria:
- No data
- Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (1000 ug/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (1000 ug/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 100 ug/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 100 ug/plate)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data
- 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
Negative with and without metabolic activation. - Executive summary:
Information from migrated NONS file, as per inquiry number 06-0000020725-70-0000, permission to refer granted by ECHA.
Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.
Negative with and without metabolic activation.
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