Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating

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

Skin irritation

The skin irritation potential of Y-15866 was investigated in a GLP-conform study according to OECD guideline 404 (Arcelin, 2011). The undiluted test substance (0.5 mL) was applied for 4 h to the clipped skin of 3 young adult New Zealand White rabbits (1 male and 2 females) under semiocclusive conditions. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation time points. No signs of systemic toxicity were seen. The mean erythema and edema scores after 24, 48 and 72 h were 0 for all 3 animals.

Eye irritation

The eye irritation potential of Y-15866 was investigated in a study according to OECD guideline 405 and in compliance with GLP (Arcelin, 2010). The undiluted test substance (0.1 mL) was placed into the conjunctival sac of the left eye of 3 young adult New Zealand White rabbits (1 male and 2 females). Scoring of irritation effects was performed approximately 1, 24, 48 and 72 h after test substance instillation. The instillation of Y-15866 into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, as well as chemosis. These effects were reversible and were no longer evident up to 48 h after treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animal at any of the examinations. No corrosion and no staining of the treated eyes and no clinical signs were observed. The individual mean scores for corneal opacity and iris light reflex after 24, 48 and 72 h were 0 for all three animals. The individual mean scores after 24, 48 and 72 h for the conjunctivae were 0, 0.33 and 0 for reddening, respectively, and 0 for chemosis for all 3 animals.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The available data on skin and eye irritation of Y-15866 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.