Registration Dossier
Registration Dossier
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EC number: 701-374-4 | CAS number: -
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to OECD guideline.
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: used for completeness check
Test material
- Reference substance name:
- Reaction products of triphenyl phosphite and isodecanol (1:2)
- EC Number:
- 701-374-4
- Cas Number:
- 25550-98-5
- Molecular formula:
- C26H47O3P
- IUPAC Name:
- Reaction products of triphenyl phosphite and isodecanol (1:2)
- Details on test material:
- - Name of test material (as cited in study report): Diisodecyl phenyl phosphite
- Commercial, purity: Not stated (Phosphorus content = 7.09%)
- Lot/batch No.: PDDP-002-03240A
- 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:
- The 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
Controlsopen allclose all
- Positive controls:
- yes
- Remarks:
- With activation
- Positive control substance:
- other: 2-aminofluorene (200 ug/mL)
- Positive controls:
- yes
- Remarks:
- Without activation
- Positive control substance:
- other: N-methyl-N’-nitrosoguanidine (2 ug/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Aqueous agar solution
NUMBER 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). The 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 resultsopen allclose all
- Species / strain:
- other:
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- > 50 ug/mL
- Species / strain:
- other:
- Metabolic activation:
- 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 (0.83 to 0.98 without metabolic activation; 1.00 to 1.24 with metabolic activation). The survival indices for the positive controls were 0.76 and 0.36 for the groups with and without metabolic activation, respectively.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material PDDP was therefore concluded to not cause preferential killing of the repair-deficient strain in this assay. - Executive summary:
The test results were negative and PDDP was determined not be mutagenic in this assay.
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