Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
other information
Study period:
January 17th, 1989 to January 27th, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
bacterial reverse mutation assay
in vitro gene mutation study in bacteria
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Test material form:
liquid
Details on test material:
Clear colourless liquid
Specific details on test material used for the study:
Purity > 98.5%

Method

Target gene:
In the Salmonella typhimurium strains (TA 1535, TA 100, TA 1537, TA 1538, TA 98) the amino acid histidine locus is the target gene.
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S-9 mix from Arochlor 1254 induced rats
Test concentrations with justification for top dose:
First experiment: 0, 4, 20, 100, 500, 2500 and 10000 μg/plate
Second experiment: 0, 4, 20, 100, 500, 2500 and 5000 μg/plate
The test compound proved to be very toxic to the bacterial strains at 100 µg/plate.
Vehicle / solvent:
DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
other: 2-Aminoanthracene

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative

Applicant's summary and conclusion

Conclusions:
The test item is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels
investigated.