Registration Dossier

Administrative data

Description of key information

One acute oral toxicty was performed in male and female rats. An oral LD50 rats was determined to be 2026 mg/kg body weight. The same same study was performed in male and female mice and an oral LD50 mice was found to be between 500 and 1000 mg/kg body weight. A third study was performed in male and female chinese hamsters and the oral LD50 value was found to be greater than 5000 mg/kg body weight.
An acute dermal toxicity study was performed in five male and five female rats. The animals were treated with bis(2,3-epoxypropyl)cyclohexane-1,2-dicarboxylate at 2000 mg/kg. The dermal LD50 in rats was found to be greater than 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 026 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Three acute oral toxicity studies were performed in rats, mice and hamsters with bis(2,3 -epoxypropyl)cyclohexane-1,2 -dicarboxylate.

The substance was found to have low to moderate acute oral toxicity. In rats and hamsters the acute oral toxicity is low with oral LD50 of 2026 mg/kg body weight and greater than 5000 mg/kg body weight respectively. In mice the acute oral toxicity is moderate with an oral LD50 value between 500 and 1000 mg/kg body weight.

One acute dermal toxicity study performed in rats showed that the acute dermal toxicity is low with a dermal LD50 value greater than 2000 mg/kg body weight.

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

- oral toxicity:

Based on the above stated assessment of the acute oral toxicity of bis(2,3 -epoxypropyl)cyclohexane-1,2 -dicarboxylate

the substance does not need to be classified 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.

- dermal toxicity:

Based on the above stated assessment of the acute dermal toxicity of bis(2,3 -epoxypropyl)cyclohexane-1,2 -dicarboxylate

(absence of toxicity up to 2000 mg/kg) the substance does not need to be classified 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.

- inhalation toxicity:

Due to the very low vapour pressure of the substance the inhalation route of exposure is considered to be unlikely. Therefore no classification for acute inhalation toxicity is deemed necessary according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according CLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.