Registration Dossier
Registration Dossier
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EC number: 477-700-1 | CAS number: 883794-93-2
Endpoint summary
Administrative data
Description of key information
Skin irritation in vivo (OECD 404): not irritating
Eye irritation in vivo (OECD 405): not irritating
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
Skin irritation/corrosion
The skin irritation properties the registered substance have been investigated in a study conducted according to OECD guideline 404 and in compliance with GLP. 3 New Zealand White rabbits were exposed to an aqueous paste of the test substance onto the shaved skin for 4 h using an occlusive dressing (aluminium foil). The treated skin was observed and evaluated at 1, 24, 48 and 72 h after application. There were no skin reactions noted in any of the animals at any observation time point. There was no indication of a systemic effect of treatment and changes in body weight during the course of the study were not remarkable. Thus, the registered substance was not irritating to the rabbits’ skin under the occlusive conditions of this test (Research Toxicology Centre, 2004).
Eye irritation
The eye irritation properties of the registered substance were assessed in a study conducted according to OECD guideline 405 and in compliance with GLP. In a group of 3 New Zealand White rabbits, 0.1 g of the unchanged test substance was instilled into one eye in a single application. The eyes were observed and reactions were evaluated 1, 24, 48 and 72 h and 7 days after instillation. A slight redness and chemosis (score of 1) and a slight to well defined ocular discharge (score of 1 to 2) were noted in all animals at the 1 h examination. A well-defined conjunctival redness and chemosis (scores of 2), a slight ocular discharge (score of 1) and a slight corneal opacity (score of 1) were observed in 1 of the 3 animals at the 24 h examination, while a complete recovery had occurred in the remaining animals of the group. A slight redness (score of 1) and a slight corneal opacity were still present at the 48 and 72 h examination in the animal. Complete recovery occurred in the third animal at day 7 examination. Thus, the registered substance was not irritating to the rabbits’ eye under the conditions of this test (Research Toxicology Centre, 2004).
Justification for selection of skin irritation / corrosion endpoint:
The available key study was selected for assessment. The study was conducted according to OECD test guideline 404 and in compliance with GLP.
Justification for selection of eye irritation endpoint:
The available key study was selected for assessment. The study was conducted according to OECD test guideline 405 and in compliance with GLP.
Justification for classification or non-classification
The available information on the registered substance is reliable and suitable for classification. The data do not meet the criteria for classification for skin or eye irritation according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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