Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
No information available (justified data waiving).
Additional information

According to column 2 of REACH Annexes on standard information requirements, the reproductive toxicity test does not have to be performed because toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance, making non reliable any available test.

Furthermore, according to column 2 of REACH Annexes on standard information requirements, the substance does not have wide dispersive use and the human exposure is limited to the workplaces where RMM can effectively limit the extent of the exposure.

In light of above issues, no reproduction toxicity test has been carried out and no testing is proposed at the present.


Short description of key information:
No information available (justified data waiving).

Effects on developmental toxicity

Description of key information
No information available (justified data waiving).
Additional information

According to column 2 of REACH Annexes on standard information requirements, the developmental toxicity test does not have to be performed because toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance.

Furthermore, according to column 2 of REACH Annexes on standard information requirements, the substance does not have wide dispersive use and the human exposure is limited to the workplaces where RMM can effectively limit the extent of the exposure.

In light of above issues, no developmental toxicity test has been carried out and no testing is proposed at the present.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance, which is not able to reach the target, should not be classified as toxic to reproduction/development.