Registration Dossier

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
liquid

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium TA 97/98/100/1535/1537/1538
Metabolic activation:
with and without
Metabolic activation system:
S9

Results and discussion

Test results
Key result
Species / strain:
other: S. Typhimurium TA 97/98/100/1535/1537/1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion