Registration Dossier
Registration Dossier
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EC number: 232-051-1 | CAS number: 7784-18-1
Endpoint summary
Administrative data
Description of key information
A GLP-compliant guideline study in rabbits has demonstrated that the substance is not a skin irritant.
A GLP-compliant guideline study in rabbits has demonstrated that the substance does not classify as an eye irritant according to CLP (1272/2008).
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/Corrosion
in vivo Skin irritation / corrosion.002 - rabbit - 2001 - key: Klimisch 1 ¿ GLP-compliant guideline (OECD guideline 404) study without deviation. Sponsored by Alufluor and conducted by Scantox (Bollen LS). Two sites on the skin of the back of each of three female New Zealand White rabbits were exposed to 500 mg of the solid substance, moistened with 0.5 mL of isotonic saline, for four hours under a dressing. After removal of the dressing, the exposed skin was cleaned with mild soap and lukewarm water prior to the skin reactions being scored an hour later, and then again at 24, 48 and 72 hours post exposure. No skin reactions were observed in any of the animals at any of the observation times, and the mean score was 0.0 for both erythema and oedema under the conditions of the experiment. The authors concluded that the substance did not classify as a skin irritant according to 93/21/EEC.
Eye Irritation
in vivo Eye irritation / corrosion.002 - rabbit - 2001 - key: Klimisch 1 ¿ GLP-compliant guideline study without deviation. Sponsored by Alufluor and conducted by Scantox (Bollen LS). One eye of each of three female New Zealand White rabbits was exposed by placing 100 mg of the solid substance under the lower eyelid and holding the eyelids closed for one second. The eyes were scored for ocular reaction one, 24, 48 and 72 hours later. After the 24 hour observation, fluorescein was instilled into the eyes then rinsed out with isotonic saline so that the eyes could be examined under UV light to detect possible corneal damage. No iridial or corneal effects were observed in any animal at any observation time. Conjunctival redness and chemosis were seen in all three animals at the one and 24 hour observations, with some effects still being present in two of the animals at the 48 hour observation. All effects had completely reversed by the 72 hour observation. The authors concluded that the substance did not classify as an eye irritant according to 93/21/EEC.
Justification for classification or non-classification
No information is available for respiratory irritation, thus the notifiable is not classified as a respiratory irritant as data are lacking.
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