Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Ames test, 5 strains, with and without S9, negative in vivo Micronucleus, mouse (male), 2000 mg/kg bw, negative
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier on analogue substance
Qualifier:
according to
Guideline:
other: B14 modified version for azodyes (ac. Prival & Mitchell)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Metabolic activation system:
S9 liver fractions of Syrian Golden hamster, untreated
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 333.3.... 5000 ug/plate
Concentration range in the main test (without metabolic activation): 333.3 ... 5000 ug/plate
Vehicle / solvent:
Bi-distilled water
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:
cytotoxicity
Remarks:
> 5000 ug/plate
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 2500 ug/plate
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 333.3 ug/plate
Remarks on result:
other: other: prelimiary test
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The analogue substance was tested for potential genetic toxicity in an in-vitro test (Ames test, EU Mehtod ) and in one in-vivo test (Micronucleus), providing negative results.

Based on the read across considerations the same applies to Acid Black 233:1 whose genotoxic potential is considered negative.

Justification for classification or non-classification

Based on the test results the substance is not classified for genotoxicity under Regulation 1272/2008