Registration Dossier
Registration Dossier
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EC number: 417-040-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Dermal:
A single semi-occlusive application of Coagulant 122 (solid) to intact rabbit skin for four hours elicited no dermal irritation.
Eyes:
A single instillation of Coagulant 122 (solid) into the eye of the rabbit elicited very slight transient conjunctival irritation. All reactions had resolved one or two days after instillation.
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:
Clinical signs All animals were observed daily for signs of ill health or toxicity. There were no signs of toxicity or ill health in any rabbit during the observation period.
Dermal responses Examination of the treated skin was made on Day 1 (i.e. approximately 60 minutes after removal of the dressings) and on Days 2,3 and 4 (equivalent to24, 48 and 72 hours after exposure).
No dermal response to treatment was observed in any animal throughout the observation period.
Eye irritation:
Clinical signs: All animals were observed daily for signs of ill health or toxicity. There were no sings of toxicity or ill health in any rabbit during the observation period.
Ocular responses: Examination of the eyes was made after 1 hour and 1,2,3 (equivalent to 24, 48 and 72 hours after instillation), 4 and 7 days after instillation. Observation of the eyes was aided by the use of a handheld light. No corneal damage or irdial inflammation was observed. Temporary mild conjunctival irritation only was seen. The eyes were normal one or tow days after instillation.
Justification for classification or non-classification
- No reactions were observed following a single semi-occlusive application of Coagulant 122 (solid) to intact rabbit skin for four hours. So, Coagulant 122 (solid) does not require labelling with the H315: Causes skin irritation, according to Regulation (EC) 1272/2008.
- A single instillation of Coagulant 122 (solid) into the eye of the rabbit elicited very slight transient conjunctival irritation. All reactions had resolved one or two days after instillation. So, Coagulant 122 (solid) does not require labelling with the H319: Cause serios damage eye in accordance with Regulation (EC) 1272/2008.
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