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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vitro

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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:
2003

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

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

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
The S9 mix prepared from a liver microsomal fraction (S9 fractions) of rats induced with Aroclor 1254
Test concentrations with justification for top dose:
312.5 microg / plate to 5000 microg / plate
Vehicle / solvent:
DMSO
Details on test system and experimental conditions:
- vehicle as negative controls
- adequate positive controls for each strain
Evaluation criteria:
number of revertant vs. negative controls; dose-relationship; historical data
Statistics:
yes (vs. negative controls)

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 1535, TA 1537, TA 98 , TA 100 and TA102
Metabolic activation:
with and without
Genotoxicity:
other: minimal increase in revertant on strain TA102 only, with metabolic activation only, at high concentrations (> 3600 µg/plate)
Cytotoxicity / choice of top concentrations:
other: thinning of bacterial lawn from 1250 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Metabolic activation: with and without (arochlor induced rat S9).
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
other: positive with metabolic activation, in only one strain and at very high concentrations (from 3600 µg/plate)
negative without metabolic activation