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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: limited but acceptable documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Principles of method if other than guideline:
Ames assay
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
BIO-76-178 CP1612 Thiofide

Method

Target gene:
ames assay
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA1535, TA1537, TA 1538, TA98, TA100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
0.1 to 500 µg/plate
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: -S9: MNNG, QM, NF; +S9: ANTH, AMQ, AAF

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA1535, TA1537, TA 1538, TA98, TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
pre-experiment (no data given)
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid

Any other information on results incl. tables

Toxicity

The compound was tested over a series of concentrations such that there was either quantitative or qualitative evidence of some

chemically induced physiological effects at the high dose level.The low dose in all cases was below a concentration that demonstrated any toxic effect. The dose range employed for the evaluation of this compound was from 0.1 µg to 500 µg per plate.

Nonactivation Test Results

The results of the tests conducted on the compound in the absence of a metabolic system were all negative.

Activation Test Results

The results of the tests conducted on the compound in the presence of the rat liver activation system were all negative.

Conclusions

The test compound, BI0 -76-178-CP 1612 Thiofide, did not demonstrate mutagenic activity in any of the assays conducted in this evaluation and was considered not mutagenic under these test conditions.

Applicant's summary and conclusion