Registration Dossier

Administrative data

Description of key information

The substance trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide was examined regarding skin irritation properties and eye irritation properties in rabbits. Under the conditions of the studies the substance showed no skin irritation and no relevant eye irritation in rabbits.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Studies in animals:

Skin irritation:

The substance trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide was examined for acute dermal irritation/corrosion properties in rabbits (patch test),according to OECD Guideline 404. Under the present test conditions, none of the three male rabbits exposed for 4 hours to 500 mg trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide/patch (semi-occlusive conditions) showed any skin reaction. There were no systemic intolerance reactions.

Eye irritation:

The influence of the substance trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide on rabbit eyes (irritation/corrosion test) was examined according to OECD guideline 405.

Under the present test conditions a single administration of the test item per animal into the conjunctival sac of the right eye of three rabbits caused following effect:

Conjunctival redness(grade 1) was observed in all animals only 1 hour after instillation. The effect was reversible within 24 hours.

The corneae and irises were not affected by instillation of the test item. There were no systemic intolerance reactions.Therefore, according to the EC Regulatiom 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide is non-irritating to eyes.

 

Justification for classification or non-classification

According to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures and based on the results of the studies trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide is not classified.