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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
OECD 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA102.
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 31.6 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 31.6 ... 5000 µg/plate
Details on test system and experimental conditions:
Metabolic activation system: Phenobarbital/beta-naphthoflavone induced male wistar rats.
A stock of the supernatant containing the microsomes was frozen in ampoules of 2 and 4.5 ml and stored at < - 75°C.
The protein concentration in the S9 preparation was 35 mg/ml. The S9 mix preparation was performed according to Ames et al.
100 mN sodium-ortho phosphat-buffer, pH 7,4 were ice-cold added to the following reagents to give final concentrations in the S9 mix of:
8mM MgCl2, 33mM KCl, 5 mM glucose-6-phosphate and 5 mM NADP.

This solution was mixed with the liver 9000 x g supernatant flid in the following proportion:
co-factor solution 9.5 parts
liver preparation 0.5 parts
During the experiment the S9 mix was stored on ice.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 5000 µg/plate)
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation