Registration Dossier

Administrative data

Description of key information

One in vivo skin irritation study was performed with bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate in New Zealand White rabbits. 0.5 mL of the undiluted test substance was applied to the shaved skin under semi-occlusive dressing during 24 hours. Slight erythema and slight oedema were observed in all animals and full reversibility was noted within 7 days.
One in vivo eye irritation study was performed with bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate in New Zealand white rabbits. 0.1 mL of the test substance was placed into the conjunctival sac of the left eye of each animal. Slight irritation was observed in all animals. After 72 hours all signs of irritation had disappeared.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

One skin irritation study was performed in rabbits. Both, slight erythema and oedema occurred on the intact and abraded skin in all animals. Full reversibility was noted within 7 days. In the eye irritation study performed in rabbits minimal effects on the conjunctivae (redness) was noted and full reversibility was noted within 72 hours.

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.

Justification for classification or non-classification

Based on the above stated assessment of the skin irritation potential of bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate the substance does not have to be classified according to Council Directive 2001/59/EC and according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.

 

Base on the above assessment of the eye irritation potential of bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate the substance does not have to be classified according to Council Directive 2001/59/EC and according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.