Registration Dossier
Registration Dossier
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EC number: 456-880-5 | CAS number: 439685-79-7
Endpoint summary
Administrative data
Description of key information
Slight signs of irritation in only 1/3 rabbits were observed in a skin irritation study.
Only reversible slight signs of irritation were observed in an eye irritation study performed in rabbits.
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 adverse effect observed (not irritating)
Additional information
In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three male New Zealand White rabbits were dermally exposed to 500 mg of Mexoryl SBF under a semi-occlusive dressing. A very slight erythema was noted in 1/3 animals from Day 1 up to Day 3. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0.7, 0 for erythema and 0, 0, 0 for edema score, respectively.
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test item, Mexoryl SBF in their left eye while the right eye remained untreated and served as control. Slight or moderate conjunctival reactions (slight or moderate chemosis, slight or moderate redness of the conjunctiva and clear discharge) were observed in all animals from Day 1 up to Day 3. No other ocular reactions were recorded during the study. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0.7, 1.0, 0 for redness of conjunctivae score and 0.7, 0.7, 0.7 for chemosis score.
Justification for classification or non-classification
As only slight reversible irritation signs were observed in skin and eye irritation studies performed in rabbits, MEXORYL SBF does not need to be classified for skin and eye irritation according to the Annex VI to the Directive 67/548/CEE and the CLP Regulation (EC) N° (1272/2008).
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