Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

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

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 98
Remarks:
S. typhimurium TA 98, TA 100, TA1535, TA1537 and TA102)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not valid
Positive controls validity:
valid
Remarks on result:
other: Non- mutagenic

Applicant's summary and conclusion

Conclusions:
Bacterial Reverse mutation test for Thioctamidoethyl Dimethylamine Maleate in Salmonella typhimurium tester strains
confirms it is non-mutagenic. The study is performed in compliance with OECD Guidelines No. 471.