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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, predates GLP, minor restrictions in reporting, but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Ames Method (Mutation Research, 1975, vol. 31, pp.347-364)
Deviations:
yes
Remarks:
For sample Terphenyl, hydrogenated in the TA1537 with and without microsomal activation at 10 µL per plate there is an additional data point for the statistical calculations. This additional number does not significantly alter the results.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: pale yellow liquid
- Purity: mixture
- Composition of mixture: 40% hydrogenated terphenyls

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix
Test concentrations with justification for top dose:
0.01, 0.04, 0.2, 1.0, 3.0, 10.0 µL/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
Controlsopen allclose all
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
with metabolic activation
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
without metabolic activation
Positive controls:
yes
Positive control substance:
other: sodium nitrite
Remarks:
without metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: 3
Statistics:
Statistical analysis for significance of difference between treatments and controls is performed for each treatment using a t-test. Values of revertants/plate are transformed using log to the base 10. Variance is calculated as within-levels pooled variance for the treatment and solvent control revertants/plate. Values of p are calculated for a one-sided t-test.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Remarks:
Salmonella tester strain TA100 was used in the absence and the presence of metabolic activation, a maximum concentration of 100 µl per plate.
Additional information on results:
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A toxic screen was run with the test compound at concentrations of 100.0, 30.0, 10.0, 1.0, 0.3 and 0.1 µL per plate using Salmonella tester strain TA100. In the absence and the presence of metabolic activation, a maximum concentration of 100 µL per plate was tolerated by the bacteria without toxic effects.
Remarks on result:
other: all strains/cell types tested, Salmonella typhimurium strains TA1535, TA1538, TA100, TA98

Applicant's summary and conclusion

Conclusions:
It is concluded that Terphenyl, hydrogenated failed to induce mutations in 4 strains of Salmonella thyphimurium, when tested up to concentrations close to the toxic range, in the absence and presence of a rat liver metabolic activation system. The test substance is hence considered to be negative for mutagenicity
Executive summary:

A study for bacterial mutagenicity was performed with Terphenyl, hydrogenated in an Ames reverse mutation test with 4 Salmonella thyphimurium strains (TA 1535, TA 1537, TA 98 and TA 100) at test concentration of 0.01, 0.04, 0.2, 1.0, 3.0, 10.0 μL/plate with and without metabolic activation. A toxic screen was run with the test compound at concentrations of 100.0, 30.0, 10.0, 1.0, 0.3 and 0.1 μL per plate using Salmonella tester strain TA100. In the absence and the presence of metabolic activation, a maximum concentration of 100 μL per plate was tolerated by the bacteria without toxic effects. All strains were tested to be negative for mutagenicity.