Registration Dossier
Registration Dossier
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EC number: 235-841-4 | CAS number: 13003-12-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Butylidenebis[2-tert-butyl-5-methyl-p-phenylene]-P,P,P',P'-tetratridecylbis(phosphine)
- EC Number:
- 235-841-4
- EC Name:
- Butylidenebis[2-tert-butyl-5-methyl-p-phenylene]-P,P,P',P'-tetratridecylbis(phosphine)
- Cas Number:
- 13003-12-8
- Molecular formula:
- C78H144O6P2
- IUPAC Name:
- 4-[2-(4-{[bis(tridecyloxy)phosphanyl]oxy}-5-tert-butyl-2-methylphenyl)pentyl]-5-methyl-2-(propan-2-yl)phenyl ditridecyl phosphite
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): Doverphos 479
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Dover Chemical Corp., Batch No. 162T022807
- Expiration date of the lot/batch: March 30, 2009
- Purity: 100 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature, moisture protected, under nitrogen
- Stability under test conditions: Stable for 3 - 4 days in acetone at room temperature
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital / beta-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Experiments I and II: 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Test concentrations were selected based on results of a pre-experimental to determine toxicity. - Vehicle / solvent:
- Acetone
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene, 4-nitro-o-phenylene-diamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Experiment I in agar (plate incorporation); Experiment II by preincubation.
DURATION
- Preincubation period: 60 minutes
- Exposure duration: at least 48 hours
NUMBER OF REPLICATIONS: three
DETERMINATION OF CYTOTOXICITY
- Method: a reduction in the number of spontaneous revertants or a
clearing of the bacterial background lawn - Rationale for test conditions:
- Guidelines and preliminary toxicity results
- Evaluation criteria:
- per guidelines
- Statistics:
- Statistical analyses were not performed, and are not required by the guidelines.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2
- 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:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- 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:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- 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:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- 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:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium 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:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The laboratory´s historical control range was slightly exceeded in the solvent control of strains TA 100 without S9 mix and WP2 uvrA with S9 mix in experiment I. This minor deviation is judged to be based on biologically irrelevant fluctuations in the number of colonies and has no impact on the outcome of the study.
Precipitation of the test item in the test tubes was observed at 2500 µg/plate and 5000 µg/plate in both experiments. Precipitation of the test item on the incubated agar plates was observed in both experiments at 5000 µg/plate in the absence of metabolic activation and from 333 µg/plate up to 5000 µg/plate in the presence of metabolic activation. The undissolved particles had no influence on the data recording.
Applicant's summary and conclusion
- Conclusions:
- Doverphos 479 is considered to be non-mutagenic in this guideline Salmonella typhimurium and Escherichia coli reverse mutation assay.
- Executive summary:
Doverphos 479 is considered to be non-mutagenic in this guideline Salmonella typhimurium and Escherichia coli reverse mutation assay.
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