Registration Dossier
Registration Dossier
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EC number: 916-331-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin corrosion/irritation: not irritating (equivalent to OECD TG 404)
Eye irritation: not irritating (equivalent to OECD TG 405)
Respiratory irritation: not irritating (based on absence of human data
and the non-irritant properties on skin and eye)
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
Skin corrosion/irritation: The ability of Cyclabute to induce skin corrosion/irritation in rabbits was investigated in a skin irritation study which was performed according to a method which is equivalent to OECD404 (pre-GLP). The test material was applied to the clipped dorsum skin for 4 hours under a semi-occlusive dressing. After removal of the patches, the treatment sites were wiped clean of excess material and examined for evidence of irritation. Further assessments were made at 24, 48 and 72 hours after treatment. Cyclabute caused very slight to slight skin irritation. The scores indicate absence of irritation.
Eye irritation: The possible eye irritation potential of Cyclabute was tested in a study equivalent to OECD 405 (procedures based on the Federal Hazardous Substance Labelling Act). Cyclabute was placed in one eye of each animal, and application was followed by a 15 day observation period. One eye of each rabbit (6 rabbits in total) was treated with a drop of local anaesthetic (amethocaine hydrochloride) prior to application of 0.1 mL Cyclabute. Treatment was followed by a 15 day observation period with typical observation points at 15 minutes, 4 hours, and daily thereafter. 6 Other rabbits were treated with Tween-80 in one eye for control purposes. Corneal, conjunctival and iridial damage was scored to determine eye irritation potential. Cyclabute, as supplied, caused slight to moderate corneal lesions affecting up to 3/4 of the corneal surface in all the animals. The lesions were associated with slight to severe corneal swelling. Slight to severe conjunctivitis developed in all the animals, iritis developed in four animals and one animal had slight discharge. The lesions had healed within 15 days. The negative control substance Tween 80, as supplied, caused slight corneal lesions in two animals, together with slight conjunctivitis in one of the animals. The lesions healed within three days. The remaining four animals were unaffected. It is concluded that Cyclabute, as supplied, is not irritating to the eyes.
Respiratory irritation: The substance is not corrosive or severely irritating (absence of classification and labelling for skin and eye irritation) which minimizes the respiratory irritation hazard (REACH guidance: 7.2.12.1, 2017).
Justification for classification or non-classification
Cyclabute does not need to be classified as irritating to the skin, eyes or for respiratory irritation in accordance with the criteria outlined in EU CLP (EC No. 1272/2008/EC and its updates).
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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