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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:
unknown
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test performed under GLP but no access to full documentation.

Data source

Reference
Reference Type:
other: Body Responsible for the test
Title:
Unnamed
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 67/548/EWG, Annex V, B.13/14 (Ames-Test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test ( without metabolic activation): 20....5000µg/plate
Vehicle:
solvent: Acetone
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: 313 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
>5000µg/plate
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
other: no information
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Observations: At concentrations of 313 micorgrams per plate and above, the test substance precipitated in the soft agar.

Applicant's summary and conclusion

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

The substance shows no mutagenic tendencies. Limited data provided by ECHA, not possible to make further conclusions.