Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: data obtained after Article 25(3) request
Title:
Unnamed
Year:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Acid Black 173 - Similar Substance 01
IUPAC Name:
Acid Black 173 - Similar Substance 01
Test material form:
not specified

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 0 ... 4800 μg/plate
Concentration range in the main test (without metabolic activation): 0 ... 5000 μg/plate
Vehicle / solvent:
Water

Results and discussion

Test results
Species / strain:
other: TA 98, 100, 1535, 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 2400 μg/plate
Additional information on results:
In higher doses of 2400, mg/plate the test substance shows a weak, root-specific, bacteria toxic effect.

Applicant's summary and conclusion

Conclusions:
Non mutagenic
Executive summary:

Method

The test substance has been assessed for its genetic toxicity potential according to the EU method B.14 (Ames test).

Result

Non mutagenic