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Toxicological information

Genetic toxicity: in vitro

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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:
1981
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
Name:
Unnamed
Type:
Constituent
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

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.