Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol is not irritating or corrosive to the rabbit skin. Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol is irritating to the rabbits eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

In a primary dermal irritation study conducted according to OECD 404 and GLP, three NZW rabbits were dermally exposed to 0.5 ml of Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol for 4 hours. Animals then were observed for three days and additional observations were made on day 5 and day 6. The single semi-occlusive application elicited variable signs of skin irritation ranging from no response to transient well defined erythema and very slight oedema. All reactions had resolved by day 6. The observed signs of skin irritation were not relevant for classification and labelling.

 

Eye irritation:

In a primary eye irritation study according to OECD TG 405 and GLP, 0.1 ml of Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol was singly instilled to the rabbits eye. Corneal opacities in all 3 animals accompanied by temporary iritis in one animal and conjunctival irritation in all 3 animals were observed. All reactions had resolved 21 days after instillation. Irritation signs were relevant for classification and labelling.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the results of the skin and eye irritation key toxicity studies, Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol is subjected to classification as R36 (Irritating to eyes) according to Directive 67/548/EEC and eye damage Cat 2 / H 319 (Causes serious eye irritation) according to Regulation 1272/2008/EC.