Registration Dossier
Registration Dossier
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EC number: 258-981-8 | CAS number: 54112-23-1
Endpoint summary
Administrative data
Description of key information
Test article is not considered to be a skin/eye irritant under the experimental conditions.
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
There are two in vivo GLP studies following OECD guidelines for skin and eye irritation that showed that no signs of toxicity were observed.
Skin irritation:
This acute skin irritation study was conducted in New Zealand White rabbits. An amount of 0.5 g test item was applied to the skin of the experimental animals as a single dose. After 4 hours, the remaining test item was removed with water at body temperature. To assess skin irritation, animals were examined at 1, 24, 48, and 72 hours after the patch removal. Additional general examinations were performed daily. At observation 1, 24, 48, 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals. The animals' individual mean scores for erythema and oedema were 0.00, 0.00 and 0.00 respectively. The primary irritation index was calculated as 0.00.
Eye irritation:
An acute eye irritation test was performed to assess the potential of test substance. The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A single amount of 0.1 g of the test item was administered as a single dose. At 24, 48 and 72 hours after treatment, no signs of eye irritation or other clinical signs were observed. As all signs of eye irritation had fully reversed the study was terminated after a period of 72 hours observation.
Based on the results presented as above, the test substance caused no primary irritation to rabbits' skin/eyes.
Justification for classification or non-classification
Based on the available data, the test article caused no skin/eye irritation to rabbits in in vivo studies. Therefore, the substance is not classified as skin/eye irritant / corrosive according to CLP (Regulation EC No.1272/2008).
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