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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Principles of method if other than guideline:
Ames assay according to Ames et al. (1975) Methods for detecting carcinogens and mutagens with Salmonella Mammalian-microsome test, Mutat. Res. 31, 347-364
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Santoflex IP, purity: 92 to 99%

Method

Target gene:
Ames assay
Species / strain
Species / strain / cell type:
other: TA98, TA100, TA 1535, TA 1537
Metabolic activation:
with and without
Metabolic activation system:
S9 mix, S9 from Aroclor 1254-induced male Spreague-Dawley rat livers
Test concentrations with justification for top dose:
0, 0.2, 4, 20, 60, 200 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: -S9: 4-nitroquinoline-N-oxide, NaNO2, 9-aminoacridine, +S9: 2-acetylaminofluorene, benzo(a)pyrene, 2-aminoanthracene

Results and discussion

Test results
Species / strain:
other: TA98, TA100, TA 1535, TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: TA98, TA100, TA 1535, TA 1537

Any other information on results incl. tables

Pretest:

A toxicity screen was conducted using test strain TA100 with and without S-9 Mix. In the toxicity screen the test sample was toxic at levels of 200 µg/plate and above. Plate incorporation tests were conducted with maximum levels of 200 µg/plate in the presence and absence of S-9 Mix. These maximum levels tested were toxic in the plate incorporation tests.

Results of the statistical analyses of plate in-corporation assay results indicated that the test sample was not mutagenic. None of the strain/microsome combinations had three treatment levels with revertants/plate significantly elevated over control values (p<0.0l) or a

significant positive dose response (p<0.0l).

The authors concluded that the test sample, Santoflex IP, was not mutagenic towards any of the Salmonella typhimurium test strains used (TA98, TA100, TA1535 or TA1537) in presence or absence of a rat liver homogenate mammalian metabolic activation system (S-9mix).

Applicant's summary and conclusion

Conclusions:
negative