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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:
No date
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: All information in this endpoint has been provided by the ECHA using the 12 years rule. This data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
This information is not provided in the migrated NONS file provided by ECHA.

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Main study with and without metabolic activation: from 100 to 5000 µg/plate.
Vehicle / solvent:
Dimethylsulfoxide (DMSO)
Details on test system and experimental conditions:
Test item precipitation observed at 1000 µg/plate.
Evaluation criteria:
This information is not provided in the migrated NONS file provided by ECHA.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Remarks:
>5000 µg/plate

Any other information on results incl. tables

In the preliminary test no cytotoxicity was observed up to the highest tested concentration (5000 µg/plate).

No more information is available in the migrated NONS file provided by ECHA.

Applicant's summary and conclusion

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

The test item was not genotoxic for bacteria (S. typhimurium and E. coli).
Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule, this data is not owned by the registrant.

The test item was evaluated for its genotoxicity to bacteria (S. typhimurium and E. coli) according to the OECD Guideline 471. No cytotoxicity was observed up to the higest tested concentration (5000µg/plate) either in the preliminary test or the main test. The test item did not induce any genotoxic response in the considered test system.