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EC number: 203-630-6 | CAS number: 108-93-0
Irritant, Category 2, Monsanto (1978a)
Mild irritant, Category 3, Monsanto (1978b)
Irritating to eyes, Category 2, OECD 405, Koch (1985)
Irreversible effects on the eye, Category 1, OECD 405, Bagley (1992)
Category 1 or 2, OECD 492, Kaluzhny (2011)
This dermal irritation study was performed according to the method described in the FHSA (Federal Hazardous Substance Act). Six New Zealand Albino rabbits were dermally exposed to 0.5 mL of the test substance of unknown purity for 24 hours. The test substance was applied to shaved intact and abraded skin using occlusive coverage. Animals were observed for up to 7 days following exposure. The skin was scored at 24, 48, 72 and 168 hours after application. Mean Draize scores (mean of all animals, mean of 24 - 72 hour readings) for the intact skin were 2.7 for erythema (three animals with a score of 3.0, 1 animal with a score of 2.7 and 2 animals with a score of 2.3) and 1.7 (four animals with a score of 2.0, one animal with 1.3 and one with 1.0) for oedema. No irritation was found after 7 days (168 hours) and no injury in depth was found.
As the erythema and oedema scores resulting from the 4-sec-exposure are less relevant for an assessment of the eye irritating property of the substance, the details are not reported here.
In this GLP compliant OECD 405 study, one eye of each of 3 rabbits was treated with 0.1 mL cyclohexanol (purity 99%) for a period of 24h, 30s or 4s. Draize scoring of eye changes were performed at 24h, 48h, 72h after instillation. Regarding the 24 hour application, the mean cornea score (all animals, mean of 24 - 72 hour readings) was 1.9 (one animal with a score of 1.7 and two animals with a score of 2.0), the mean iris score was 0, the mean conjuctivae score was 2.1 (one animal with a score of 2.3 and two animals with 2.0) and the mean chemosis score was 2,3 (one animal with a score of 2,3, one with 2,7 and one with 2.0). Effects were reversible within 10 days in all animals.
In a well-documented human study (van Thriel et al. 2006), cyclohexanol was observed to have respiratory tract irritating properties from concentrations of 427 ppm (1.77 mg/mL).
The substance is classified as Skin Irritant Cat. 2. The available relevant data support the legal classification. The result of the key study triggers a classification with Cat. 2 under Regulation (EC) No 1272/2008, Annex I, whereas the result of a supporting study triggers a classification with Cat. 3. Both studies are of comparable quality. Since an erythema score of >= 2.3 was observed for all animals in the key study, the more stringent classification of Cat. 2 "irritating to skin" is recommended.
The harmonised CLP classification of this substance does not contain a classification for eye irritation.
On the basis of the Bagley (1992) study, a classification with Cat. 1 under the Regulation (EC) No. 1272/2008, Annex I, may be warranted. However, in three other studies being adequate for an assessment of classification and labelling, the effects on eyes were shown to be less severe and reversible within 21 days. Thus a classification with Cat. 2 according to Regulation (EC) No. 1272/2008, Annex I, criteria is recommended, based on weight-of-evidence.
The harmonised CLP classification of cyclohexanol includes a classification regarding its irritation potential to the respiratory tract. The legal classification is supported by the findings on respiratory tract irritation described in the available human studies.
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