Registration Dossier

Diss Factsheets

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

In a dermal irritation study according to EPA OPP 81-5 octadecyl isocyanate was applied under occlusive dressings for 4 hours to the shaved skin of 6 rabbits. Skin irritation was assessed after 4, 24, 72 hours and 7 and 14 days using the Draize scale. The modified primary irritation index was 1.93 of max. 4. According to EPA criteria, the test article is considered to be Category IV (mild or slight irritation). However, the reactions noted at 72 hours and on days 7 and 14 indicate that octadecyl isocyanate can produce delayed skin reactions of a severe nature (Cerven, 1989a).

Eye irritation

In an eye irritation study according to EPA OPP 81-4 octadecyl isocyanate was instilled into the conjunctival sac of one eye of 6 (without eye flush) or 3 (with eye flush) rabbits. Eye irritation was assessed after 1, 2, 3, 4, 7 and 14 days using the Draize scale. In this study there was no corneal opacity or iritis in animals with washed or unwashed eyes. Moderate conjunctival irritation, composed primarily of chemosis, was noted in all animals with washed or unwashed eyes. The chemosis reactions were of a delayed nature, showing up in some animals as late as day 7 (unwashed eyes) or as late as day 4 (washed eyes). By day 14, all washed and unwashed eyes appeared normal. There were no abnormal systemic signs noted during the observation period. According to EPA criteria, octadecyl isocyanate was considered to be Category II (corneal involvement or irritation clearing in 8-21 days) in the unwashed and the washed eyes (Cerven, 1989b).


Effects on skin irritation/corrosion: highly irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Skin irritation

Not classified under Annex I of Directive 67/548/EEC or Annex VI-1 of Regulation (EC) No 1272/2008. Deviating from that a self classification according to Annex I of Regulation (EC) No 1272/2008 with Category 2 (H315: Causes skin irritation) is recommended based on the results of the available key skin irritation study in rabbits.

 

Eye irritation

Not classified under Annex I of Directive 67/548/EEC or Annex VI-1 of Regulation (EC) No 1272/2008. Deviating from that a self classification according to Annex I of Regulation (EC) No 1272/2008 with Category 2 (H319: Causes serious eye irritation) is recommended based on the results of the available key eye irritation study in rabbits.