Registration Dossier

Administrative data

Description of key information

The irritation potential of tetrahydro-2-methylfuran was  assessed by a set of in vitro assays.   
Tetrahydro-2-methylfuran was not considered to be corrosive to skin, as determined in an in vitro assay (EPISKIN) conducted in accordance with current OECD guideline and GLP (Harlan 2012a).
Tetrahydro-2-methylfuran was considered to be a skin irritant, as determined in an in vitro assay (EPISKIN) conducted in accordance with current OECD guideline and GLP (Harlan 2012b).
Tetrahydro-2-methylfuran was considered to be an ocular corrosive/severe irritant, as determined in an in vitro assay (BCOP) conducted in accordance with current OECD guideline and GLP (harlan 2012c).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The skin irritation potential of tetrahydro-2-methylfuran was assessed by a tiered approach comprising of two consecutive in vitro assays. Both studies were conducted in accordance with current OECD guideline and GLP. The first study assessed

whether the test material was corrosive to skin in a Episkin reconstructed human epidermis model (Harlan 2012a). The assay found the test material not corrosive to skin. The second study considered the irritation potential of the test material, also in the Episkin reconstructed human epidermis model (Harlan 2012b). The relative mean viability of the test item, which was calculated relative to positive and negative control tissues was 40.4% which corresponds to the test material being an irritant. The eye irritation potential of tetrahydro-2 -methylfuran was assessed in the bovine corneal opacity and permeability assay (Harlan 2012b). The undiluted test item was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The corneas treated with the test item were cloudy post treatment and post incubation. The corneas treated with negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.

Justification for selection of skin irritation / corrosion endpoint:
The only reliable study available, conducted to appropriate OECD guideline and GLP.

Justification for selection of eye irritation endpoint:
The only reliable study available, conducted to appropriate OECD guideline and GLP.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available information tetrahydro-2 -methylfuran is classified as Category 1 Eye Damage, H318: Causes serious eye damage and Category 2 Skin Irritant, H315: Causes skin irritation, in accordance with EC Regulation No. 1272/2008.