Registration Dossier

Administrative data

Description of key information

Skin (OECD 404): not irritating (0.5 g, rabbit, semi-occlusive, 4 h)
Eye (OECD 405): not irritating (0.1 mL/46 mg, rabbit, unwashed eye)

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

A study assessing the skin irritation potential of TS-2863 (2-(2-hexyl-decyloxy)-benzamide) was performed according to OECD 404 (Pels Rijcken, 1999). 0.5 g test substance, moistened with acetone, was applied to the shaved skin of rabbits, under semi-occlusive conditions for 4 hours. As the test substance is insoluble in water, acetone was selected as the vehicle. Since acetone evaporates quickly, good skin contact during the 4 -hour exposure can not be guaranteed. However, the study is considered to be acceptable. There were no skin irritation effects observed in any of the animals at reading time points 24, 48 and 72 hours after exposure ended. No staining of the treated skin was noted.

In the acute dermal toxicity study, TS-2863(moistened with water) was applied to the shaved skin of rats under occlusive conditions at the limit dose of 2000 mg/kg bw for 24 hours (Pels Rijcken, 1998). Erythema (grade 1 on a scale of 4), scales and/or scabs were noted in the treated skin area of all animals from the second day after removal of the dressing. The erythema had cleared completely in all animals by day 9 and the scales/scabs by day 11 of the study period.

The skin irritation study, performed according to the standard guidelines (4 -hour exposure under semi-occlusive conditions) and using acetone to moisten the substance, did not result in skin irritation. The occlusive conditions and longer exposure period (24 h) employed in the acute dermal toxicity study showed that even under very severe conditions the test substance did not cause marked skin irritation. Therefore, 2 -(2 -hexyl-decyloxy)-benzamide is considered not to be a skin irritant.

To evaluate the eye irritation potential of TS-2863, a study was performed according to OECD 405 (Pels Rijcken, 1998). 0.1 mL (approximately 46 mg) was instilled into one eye of 3 male rabbits. The eyes were not washed after instillation. The irritating effect was assessed 24, 48 and 72 hours after the treatment. Mild irritation of the conjunctivae was noted in 1/3 rabbits 24 hours after exposure and consisted of slight redness, chemosis and discharge. The effects had cleared completely within 72 hours. Based on this study, 2 -(2 -hexyl-decyloxy)-benzamide is not considered to be an eye irritant.

Justification for classification or non-classification

The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.