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:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
FAT 92274/B

Results and discussion

Any other information on results incl. tables

In experiment I, toxic effects, evidenced by a reduction in the number of revenants, occurred without metabolic activation in strain TA 98 from 1000.0 ug/plate up to 5000.0 ug/plate. In experiment II, toxic effects occurred at 5000.0 ug/plate without metabolic activation in strain TA 100, and with and without metabolic activation in strains TA 1535, TA 1537, and TA 98. The plates incubated with the test article showed normal background growth up to 5000.0 ug/plate with and without S9 mix in all strains used. No substantial increases in revertant colony numbers of any of the four tester strains were observed following treatment with 2(3-Amino-benzamino)ethylsulfonylethylhydrogensulfat feucht at any concentration level, either in the presence or absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.

Applicant's summary and conclusion

Conclusions:
In conclusion, it can be stated that during the described mutagenicity test and under the
experimental conditions reported, the test article did not induce gene mutations by base pair
changes or frameshifts in the genome of the strains used.
Executive summary:

did not induce gene mutations