Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.

Additional information