Registration Dossier
Registration Dossier
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EC number: 232-102-8 | CAS number: 7786-67-6
Endpoint summary
Administrative data
Description of key information
Skin irritation:
EpiDerm™ skin corrosion/irritation test (acc. to OECD TG 431, 439 and GLP): irritating (BASF 2010; 61V0358/10A142)
Eye irritation:
Bovine Corneal Opacity and Permeability Test (acc. OECD TG 437 and GLP): no serious eye damage (BASF 2010; 63V0358/10A143)
Key value for chemical safety assessment
Additional information
Avaliable toxicity data for isopulegol have been derived with or have been filed under the identity of a respective enantiomer, i.e. (1R,2S,5R)-5-methyl-2-(1-methylethenyl)-cyclohexanol (CAS 89 -79 -2). This enantiomer represents one main component of the registered substance DL-isopulegol and the respective data allow to cover the given toxicological endpoint.
Skin irritation:
In the chosen key study, i.e. an in vitro EpiDerm™ skin corrosion/irritation test according to OECD TG 431, 439 and GLP, isopulegol shows a skin irritation potential under the test conditions chosen. In line, dose related irritation with erythema, edema and induration were noted in an acute dermal toxicity study in rabbits (Lynch 1971). The test substance was not irritating when applied at 8% in petrolatum to human subjects in a 48 -hour closed-patch test (Kligman 1971).
Eye irritation:
In the chosen key study, i.e. an in vitro Bovine Corneal Opacity and Permeability Test according to OECD TG 437 and GLP, the observed results led to the conclusion, that isopulegol does not cause serious eye damage under the test conditions chosen. However, the test protocol provides no evidence for an exclusion of an eye irritation potential.
Justification for classification or non-classification
Skin irritation:
The present data fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and a classification "irritating to skin" (R38) and "skin irritant" (category 2) is warranted.
Eye irritation:
Since an eye irritation potential cannot be excluded based on the current data available, isopulegol is to be classified as "irritating to eyes" (R36; Category 2) according to 67/548/EEC and regulation (EU) 1272/2008, respectively.
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