Registration Dossier
Registration Dossier
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EC number: 270-478-5 | CAS number: 68442-22-8
Endpoint summary
Administrative data
Description of key information
This substance is an EU Category 2 skin irritant and an EU Category 1 eye irritant with a specific concentration limit of 10% for eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin Irritation/Corrosion:
A key study of the skin irritation potential of an analog of this substance (EC 247-810-2) was conducted with New Zealand White rabbits (Mallory, V.E., 1986). Each test site was treated with 0.5 ml of the test material for 4 hours. Following the exposure period, irritation responses were graded at 1, 24, 48, and 72 hours and daily for a total of 11 days. The mean erythema and edema scores for 24, 48, and 72 hours were 2.66 and 1.78, respectively. Effects were fully reversible within 11 days in all but one animal.
In a supporting study this substance was applied to New Zealand white rabbits under semi-occlusive dressing for 24 hours at concentrations of 100%, 50%, 25%, 10%, and 5% (Costello, B.A. and Moore, G.E., 1984) in accordance with 40 CFR 163.81-5, Federal Register, August 22, 1978 and EPA Pesticide Assessment Guidelines November 1982. At the end of the exposure period the test sites were wiped and were evaluated in accordance with Draize. The resulting average 24, 48, and 72 hours for erythema/edema at 100%, 50%, 25%, 10%, and 5% were 1.33/0.34, 0.89/0.06, 0.78/0, 0.56/0, and 0.22/0.
Serious eye damage/irritation:
In a key study, this substance was administered to the eyes of six New Zealand white rabbits (Costello, B.A., 1983)in accordance with CFR 16, Section 1500.42.Ocular irritation was assessed up to 21 days.The average (24-72 hr) corneal opacity, iritis, conjunctivae redness and chemosis scores were 0.8, 0.6, 1.8, and 2.9, respectively. Corneal opacity, conjunctivae redness and swelling were not reversible in the unrinsed eyes following 21 days.
Effects on skin irritation/corrosion: moderately irritating
Effects on eye irritation: highly irritating
Justification for classification or non-classification
In accordance with EU CLP (Regulation (EC) No. 1272/2008) classification of this substance is required for skin irritation.
In accordance with EU CLP (Regulation (EC) No. 1272/2008) classification of this substance is required for eye irritation.
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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