Registration Dossier
Registration Dossier
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EC number: 207-434-1 | CAS number: 471-01-2
Endpoint summary
Administrative data
Description of key information
Isophorone is an eye irritant and a respiratory irritant but does not irritate the skin.
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:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation
One guideline study was performed on rabbits with 0.5 mg (corresponds to 1500 mg isophorone/kg bw) and did not result in significant irritancy (Potokar et al., 1985). Only slight irritations were seen after application of 0.5 ml according to a modified Draize protocol (24 hrs exposure) (Dutertre-Catella, 1976). After application of 200 mg/kg isophorone (24 hrs exposure) only slight erythema and desquamation during the first four days after 4 hours of exposure was observed (Esso Research, 1964). The findings were fully reversible.
Eye irritation
Two Draize tests were performed on each 6 male and female rabbits. When applied undiluted to rabbits’ eyes isophorone is moderately to severely irritating to the eyes (Esso Research, 1964; Truhaut et al., 1972). In one study marked irritation was observed which reversed within 14 days but was still present after 7 days (Esso Research, 1964), while in the other study, irritant scores of 14/80 (cornea), 0/10 (iris) and 6/20 (conjunctiva) were reported and had reversed within 7 days (Truhaut et al., 1972).
Effects on eye irritation: irritating
Effects on respiratory irritation: irritating
Justification for classification or non-classification
Based on the results of the skin and eye irritation studies, isophorone should be classified with Xi, R36/37 according to Directive 67/548/EEC and Eye irrit 2, H319 and STOT SE 3, H335 according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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