Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
No data are available for the substance.
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information
Short description of key information:
No data are available for the substance.

Effects on developmental toxicity

Description of key information
No data are available for the substance.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance is a salt that dissociates in aqueous matrix in its acid and alkaline constituents.

Considering the toxicological profile of the intermediate no information is available: for this reason the constituents of the substance itself (2-[4-(cyclopropanecarbonyl) phenyl]-2-methylpropanoic acid and cyclohexanamine) are taken into account in order to assess the two moiety singularly.

 

The acid moiety of CPKA-540 is not well known as reported due to the lack of literature data. By contrast, the alkaline moiety of CPKA-540 is acknowledged for its hazard as reported in Annex VI of CLP.

 

Cyclohexanamine is classified as Repro 2, H361.

It is reasonable considered that the sistemic toxicity of CPKA-540 is mantained as is the cyclohexanamine. Reproductive toxicity data on cyclohexanamine report a significant decrease in the number of implantation sites and in the number of liveborn fetuses, increased perinatal mortality and a significant reduction in weight gain of the offspring were observed in treated animals.

Therefore, according to Regulation (EC) n. 1272/2008, the substance of interest should be classified as Repro 2; H361.