Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

The test article (1,4 cyclohexanedicarboxylic acid; CHDA) was applied to skin under occlusion at concentrations of 0.5 and 1.0 g/kg to one and three guinea pigs, respectively, for 24 hours. The test site was evaluated for evidence of skin irritation for 24 hours after removal of the occlusive dressing. Data indicate that all animals displayed slight edema at the test site. The test article was determined to be a slight skin irritant.

Eye irritation

The test article was instilled into both eyes of 3 rabbits, and for each rabbit, the test article was removed from one eye by washing. Each eye was evaluated for evidence of irritation at 1, 24, and 48 hours after instillation, and after 7 and 10 days. In the unwashed eyes, moderate irritation was observed in 3 of 3 eyes at 1 and 24 hours after instillation, and slight irritation was observed in 3 of 3 eyes at 48 hours after instillation. Irritation was accompanied by moderate corneal opacity at 24 and 48 hours after instillation and by slight corneal opacity after 7 days. By 10 days after test article instillation, 3 of 3 eyes appeared normal. In the washed eyes, slight irritation was observed in 3 of 3 eyes at 1, 24, and 48 hours after instillation, and by 7 days after test article instillation,3 of 3 eyes appeared normal.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

1,4-cyclohexanedicarboxylic acid (CHDA) produced slight, transient irritation when applied to the skin of guinea pigs, and therefore does not satisfy the criteria for classification as a dermal irritant according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). When instilled into the eye, CHDA produced moderate corneal opacity in rabbits that was observed in 2 of 3 rabbits after 7 days but resolved fully by 10 days after treatment. Based upon these findings, CHDA was determined to produce reversible effects on the eye (category 2) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.