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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: scientifically acceptable and well documented

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
The objective of this study was to evaluate the test compound for genetic activity in microbial assayson Salmonella typhimurium strain TA98, TA100, TA1535, TA1537, TA1538 and Saccharomyces cerevisiae strain D4 with and without the addition of mammalian metabolic activation preparations.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
light brown powder

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strain TA98, TA100, TA1535, TA1537, TA1538 and Saccharomyces cerevisiae strain D4
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix
Test concentrations with justification for top dose:
0.5, 5.0, 50, 250 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: nonactivation: methylnitrosoguanidine, 2-nitrofluorene, quinacrine mustard; activation: 2-anthramine, 2-acetylaminofluorene, 8-aminoquinoline, dimethylnitrosamine

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium strain TA98, TA100, TA1535, TA1537, TA1538 and Saccharomyces cerevisiae strain D4
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

RESULTS

The test compound, BI0-76-109 FLECTOL H, Lot 5E866, was examined for mutagenic activity in a series of in vitro microbial assays employing Salmonella and Saccharomyces-indicator organisms. The compound was tested directly and in the presence of liver microsomal enzyme preparations from Aroclor-induced rats. The following results were obtained:

A. Toxicity

The compound was tested over a series of concentrations such that there was 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 0.5 µg ~ 250 µg per plate.

B. Nonactivation Test Results

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

C. Activation Test Results

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

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

The objective of this study was to evaluate the test compound for genetic activity in microbial assayson Salmonella typhimurium strain TA98, TA100, TA1535, TA1537, TA1538 and Saccharomyces cerevisiae strain D4 with and without the addition of mammalian metabolic activation preparations.

The test compound, BIO-76-109 FLECTOL H, Lot 5E866, did not demonstrate mutagenic activity in any of the assays conducted

in this evaluation and was considered not mutagenic under these test conditions.