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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triphenyl Phosphit
- Physical state: clear colorless liquid

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced S-9 fraction from rat liver
Test concentrations with justification for top dose:
5, 10, 50, 100 and 500 µg/plate
Vehicle / solvent:
ethanol
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: see below
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48h at 37°C

NUMBER OF REPLICATIONS:
Samples are run in duplicate

POSITIVE CONTROLS
- with metabolic activation:
TA-1535, cyclophosphamide (200 µg/plate); TA-1537, TA-1538, TA-98 and TA-100, benzofalpyrene 5 µg/plate

- without metabolic activation:
TA-1535 and TA-100, sodium azide (1 µg/plate); TA-1537, aaminoacridine (100 µg/plate); TA-1538 and TA-98, 2-nitrofuorene (50 µg/plate)
Evaluation criteria:
The assay is scored as the ratio of the number of macroscopic colonies on the test plate over the number of macroscopic colonies on the control plate. This is taken as the mutagenic index. A compound is considered to have a positive response if the mutagenic index is 2.0 and the apparent mutagenicity exhibits a dose response relationship.

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: A white precipitate formed in the aqueous agar solution at 50, 100 and 500 µg/plate
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
The test article was not mutagenic under the conditions of this study described.