Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In a study (Chung 1981), being reliable with restrictions, conducted similar to OECD test guideline 471, the registered substance was negative, This result is supported by a second study (Chung 1978).

In a GLP-study according to OECD test guideline 473, the registered substance was negative as it did not induce chromosomal aberrations.

In a GLP-study according to OECD test guideline 476, the registered substance was negative as it did not induce biologically relevant mutations.

These negtive results are supported by an in vivo study:

FD & C Yellow No. 6, which is rapidly and almost completely metabolised in the gut inter alia to sulphanilic acid, i.e. the registered substance, gave a negative result in both rat and mouse bone marrow micronucleus tests after a single oral dose of up to 2000 mg/kg.

In summary, the registered substance is considered not be genetically toxic.


Short description of key information:
Bacterial reverse mutation assay (Ames): negative
Chromosomal aberration: negative
HPRT: negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on in vitro and in vivo data, the registered substance has not to be classified for genetic toxicity and mutagenicity.