Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a Guinea pig hypersensitivity test according to the Magnusson & Kligmann procedure, all animals showed a skin sensitising effect.

After re-examination of the substance description and based on the ECHA Guidance for identification and naming of substances under REACH, the lead registrant agreed with the other SIEF members that the identifiers (CAS number and EC name) used for the toxicological, ecotoxicological and physico-chemical testing are not representative of the UVCB substance used for the testing. Consequently, the EC name Bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate and CAS number 5493-45-8, mentioned in the testing reports and refering to a monoconstituent substance are incorrect and should be read as 1,3-Isobenzofurandione, hexahydro-, reaction products with epichlorohydrin with CAS number 1395383-69-3, which is representative of the registered UVCB substance used effectively.


Migrated from Short description of key information:
One skin sensitisation study (Maximization test) was performed with Guinea Pigs according to OECD 406. The intradermal induction was performed with bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate at 0.1% in sesame oil and the epidermal induction was performed with the substance at 30% in vaseline.
The challenge was perfomed with bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate at 10% in vaseline. After 24 hours all animals showed a skin sensitising effect.

Justification for classification or non-classification

- skin sensitisation:

Based on the above stated assessment of the skin sensitisation potential of bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate (100% of the animals sensitized in Magnuson & Kligman test) the substance needs to be classified as R43 (May cause sensitisation by skin contact) according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and Skin Sens. 1 (H317: may cause an allergic skin reaction) according CLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.

- respiratory sensitisation:

As no data on respiratory sensitization is available for bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.