Registration Dossier

Administrative data

screening for reproductive / developmental toxicity
Data waiving:
other justification
Justification for data waiving:
Justification for type of information:
A temporary waiving is submitted for the substance as no experimental data for reprotoxicity and repeated dose toxicity (28 days) are available to date. It was not possible to declare that experimental studies were planned as the testing strategy is not yet consolidated.
In fact, a test strategy is currently under development to cover the evaluation of the dermal toxicity, the oral repeated dose toxicity and the reprotoxicity of the Sepisol Fast Yellow MG-F and other dyes belonging to the same categroy of solvent azodye from the manufacturer portefolio and that are or will be procuded in quantities between 1-10 T and 10-100 T. A category approach based on grouping of substances will be trialled. The purpose is to optimize studies performed on animals, according to ethics and animal welfare for the current substances for which a dossier is already needed and for the ones for wich a dossier will be needed in the near future, and to consolidate the knowledge of the (eco)toxicity of these substances.
To compensate this lake of data, the risk assessment of the Sepisol Fast MG-F has been done considering the data available from another dye from the same manufacturer and belonging to the category of solvent azodye. See the attached justification document for more details.
Reason / purpose:
read-across source

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion