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Diss Factsheets

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)
Epiocular (TM) (acc. to draft OECD guideline and GLP): irrating (BASF 2015, 62V0358/10A533)

Key value for chemical safety assessment

Additional information

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 (BASF2010; 61V0358/10A142). 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:

Two in vitro tests are available to assess the eye irritation potential of isopulegol in a weight of evidence. In 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 (BASF2010; 63V0358/10A143). However, the test protocol provides no evidence for an exclusion of an eye irritation potential.

Therefore, a second in vitro test, i.e. the EpiOcular™

test according OECD (2014a) Draft Proposal for a New Test Guideline and GLP the has been performed with isopulegol (BASF 2015, 62V0358/10A533). A decrease in the mean viability value has been observed, i.e. 20.5% of the negative control. The respective positive control (methyl acetate) showed a mean viability value of 35.4%. Based on the observed results and applying the evaluation criteria it was concluded, that isopulegol shows an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.

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:

Based on the present in vitro data in a weight of evidence, 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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