Registration Dossier
Registration Dossier
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EC number: 406-690-3 | CAS number: 43136-14-7 MDI/ODA
Endpoint summary
Administrative data
Description of key information
The skin irritancy potential of the test item was assessed in a study conducted according to EU Annex V guidelines. The mean and maximum edema and erythema scores were 0 for all animals. The eye irritancy potential of test item was studied according to EU Annex V guidelines in three rabbits. The overall scores at 24, 48 and 72 hours for the three animals were 0, 1.7 and 0.3 for conjunctivae (redness), 0, 0.3 and 0 for chemosis, 0 for all animals for cornea and 0, 0.3 and 0 for iris. A maximum score of 2 was observed at 72 hours for conjunctivae (redness) and a maximum score of 1 was observed at 24 hours for chemosis and iris. Following fluorescein application to the eyes of all three animals at 24 hours, 30% of the total cornea area in animal number 2 was stained indicating epithelial damage. A repeat of fluorescein treatment at 72 hours yielded negative findings. Therefore, changes were fully reversible within 7 days and the test item is not classified for eye irritation.
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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The test item is not classified as irritant to skin as the in vivo rabbit study was negative. The test item is not classified for eye irritation as no classifiable effects were observed in the study conducted on the test item. Additionally, the substance does not have a harmonised classification for either skin or eye irritation.
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