Registration Dossier

Administrative data

Description of key information

Studies of skin and eye irritation in vivo are available for the read-across substance.

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:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A skin irritation study was conducted with the read-across substance (C8 -18) Betadet SHR according to OECD Test Guideline 404. The test material was applied to the skin of 3 rabbits (0.5 mL) for 4 hours. The animals were observed for 7 days. The treatment sites were assessed after 1, 24, 48 and 72 hours. Very slight erythema (grade 1) was observed in all animals approximately 60 minutes following removal of the patch; this persisted to 48 hours in one rabbit.  No oedema was observed in any rabbit. Betadet SHR was found to cause minimal transient skin irritation in this study and does not require classification as a skin irritant under CLP.

Eye irritation

The read-across substance (C8 -18) Betadet SHR was instilled (0.1 mL) into one eye of three New Zealand White rabbits in accordance with OECD TG 405. Ocular irritation was scored for up to 21 days after instillation, using the Draize scale. Signs of irritation included corneal opacity (Grade 1 in all animals, fully reversible by 21 days); iridial inflammation (Grade 1 in all animals, fully reversible by 14 days); conjunctival erythema (Grade 3 in all animals, fully reversible by Day 21); and conjunctival chemosis (Grade 2-3). Grade 1 conjunctival chemosis persisted in one rabbit at 21 days. The mean scores for corneal opacity (mean score ≥1), iridial inflammation (mean score ≥1) and conjunctival erythema (mean score ≥2) result in classification of the substance as a Category 2 eye irritant according to the CLP Regulation; however the lack of complete reversibility of conjunctival chemosis in one rabbit at 21 days triggers classification in Category 1.

Justification for classification or non-classification

Based on the results of the skin irritation study, classification is not required. Based on the results of the eye irritation study, classification for eye irritation in Category 1 is required.