Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the OECD TG 471 (draft).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: draft OECD TG 471
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Method

Target gene:
HIS operon (S. thyphimurium)
TRY operon (E. coli)
Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium TA 100, TA 98, TA 1535, TA 1537, TA 1538, and Escherichia coli WP2 and WP2 uvrA
Additional strain / cell type characteristics:
other: mutations in HIS or TRY operon
Metabolic activation:
with and without
Metabolic activation system:
rat liver homogenate (S9 mix) with standard co-factors with metabolic activation (Aroclor)
Test concentrations with justification for top dose:
100, 250, 500, 750, 1000 and 1250 µg/plate.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 9-Aminoacridine, 2-Aminoanthracene, Daunomycin, 1-Ethyl-2-nitro-3-nitrosoguanidine, Methyl methanesulfonate, N-Methyl-N-nitro-N-nitrosoguanidine , 2-Nitrofluorene, l,2-phenylene diamine
Details on test system and experimental conditions:
plate incorpoaration protocol
Bacteria suspension for test 0.1 ml
Tested sample (or solvent) 0.1 ml
Na-phosphate buffer (in trials without metabolic activation) 0.5 ml
S-9 mix (in trials with metabolic activation) 0.5 ml
Soft agar solution 2.0 ml

Incubation of plates
Temperature 37 °C
Hours 48
Statistics:
no statistics performed

Results and discussion

Test results
Species / strain:
other: all strains tested
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>1250 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

The test material is considered to be not mutagenic in this bacterial mutagenicity assay.
Executive summary:

Study Design

The test material was tested for its potential to induce reverse mutation in bacteria using Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 and Escherichia coli WP2 and WP2 uvrA as tester strains. The test item was investigated at concentrations between 100 and 1250 µg/plate in the presence and absence of a metabolic activation system (S9 mix derived from male rats pre-treated with Aroclor 1254) using the plate incorporation technique. Two experiments were performed. Negative solvent control and appropriate positive controls were carried along. The design of the study meets the requirements of test guideline OECD 471.

Results

In a preliminary test using concentrations between 5 and 10000 µg/plate, toxicity was observed at concentrations >1250 µg/plate.

The test material was dissolved in DMSO and tested at concentrations ranging from 100 to 1250 µg/plate.

The test material did not show any mutagenic activity up to the highest concentration tested in the presence and absence of metabolic activation where the substances used as positive controls led to a clear increase in revertant colonies in the expected range.

Conclusion

Based on the results of this study, the test material is considered to be not mutagenic in this bacterial mutagenicity assay.