Registration Dossier
Registration Dossier
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EC number: 278-758-9 | CAS number: 77745-66-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Deviations:
- not specified
- Principles of method if other than guideline:
- Based on Slater et al. (1971) Cancer Res. 31:970-973.
- GLP compliance:
- yes
- Type of assay:
- other: DNA repair-suspension assay
Test material
- Reference substance name:
- Triisodecyl phosphite
- EC Number:
- 246-998-3
- EC Name:
- Triisodecyl phosphite
- Cas Number:
- 25448-25-3
- Molecular formula:
- C30H63O3P
- IUPAC Name:
- Phosphorus acid, triisodecyl ester
- Details on test material:
- - Name of test material (as cited in study report): Triisodecyl phosphite - Commercial, purity: > 97% (Phosphorus content = 6.17 %)- Lot/batch No.: TDPx-003-04070A- Supplier: Borg Warner Company, Parkersburg, WV
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Escherichia coli tester strains W3110 (pol A+) and p3478 (pol A-)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 fraction from rat liver was induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 0, 0.1, 1, 5, 10, and 50 ug/mL
- Vehicle / solvent:
- No further information available.
Controlsopen allclose all
- Positive controls:
- yes
- Remarks:
- (With activation)
- Positive control substance:
- other: (2-aminofluorene (200 ug/mL)
- Positive controls:
- yes
- Remarks:
- (With activation)
- Positive control substance:
- other: (N-methyl-N’-nitrosoguanidine (2 ug/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Aqueous agar solutionNUMBER OF REPLICATIONS: Samples were run in duplicate, with and without metabolic activation.
- Evaluation criteria:
- The suspension test is scored as the ratio of the number of pol A- survivors over the number of pol A+ survivors (Survival Index). A test material is considered positive if the Survival Index is less than 0.8 and the differential toxicity exhibits a dose-response relationship.
Results and discussion
Test results
- Species / strain:
- other: Escherichia coli tester strains W3110 (pol A+) and p3478 (pol A-)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 50 ug/mL)
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The survival indices at all doses for the test material were greater than 0.80, with or without metabolic activation (0.86 to 1.01 without metabolic activation; 1.04 to 1.28 with metabolic activation). The survival indices for the positive controls were 0.64 and 0.41 for the groups with and without metabolic activation, respectively.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negativeThe test material TDP was therefore concluded to not cause preferential killing of the repair-deficient strain in this assay.
- Executive summary:
Interpretation of results (migrated information):negativeThe test material TDP was therefore concluded to not cause preferential killing of the repair-deficient strain in this assay.
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