Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Sample reference: Ref NBW 8809/52
- Supplier: ICI Colours and Fine Chemicals, Blackley, UK.
- CTl reference number: Y04203/002/001.
- Physical state: red powder
- Analytical purity: 90%

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
5556 µg/plate,
5000 µg/plate,
1000 µg/plate,
200 µg/plate
40 µg/plate
8 µg/plate
1.6 µg/plate (not WP2)

=>3 plates per dose and for each strain
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Dimethylsulphoxide (DMSO)
Positive controls:
yes

Results and discussion

Any other information on results incl. tables

The Substance has been evaluated in the bacterial mutagenicity assay of Maron and Ames (1983), using five strains of Salmonella typhimurium (TAI535, TA1537, TA1538, TA98 and-TA100), and also one strain of Escherichia coli (WP2 uvrA pKM101), following protocols complying with OECD Guidelines Nos. 471 and 472 (OECD, 1983a and 1983b).

In two separate experiments, the compound did not induce any significant, reproducible increases in the observed numbers of revertant colonies in strains TA1535 and WP2 uvrA pKM101 in either the presence or absence of S9.

In the first experiment in strain TAl537 a limited, dose-related increase in the observed number of revertant colonies was obtained. This had only lmited reproducibility in the second experiment.

In strains TA1538, TA98 and TA100 (both with and without S9) significant, dose-related increases in the observed numbers of revertant colonies were obtained in each experiment.

In each experiment, the positive controls responded as expected, indicating that the assay was working satisfactorily.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this assay, the Substance therefore gave an unequivocal positive, ie mutagenic, response in strains TA1538, TA98 and TA100 in both the presence and absence of an auxiliary metabolising system (S9).
Executive summary:

Under the conditions of this assay, the Substance therefore gave an unequivocal positive, ie mutagenic, response in strains TA1538, TA98 and TA100 in both the presence and absence of an auxiliary metabolising system (S9).