Registration Dossier

Administrative data

Description of key information

In studies in rabbits, tetrahydrofuran was not rated as a skin irritant but did cause severe eye irritation with possible irreversible effects.

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin Irritation

In a key study conducted by the method of Draize, albino rabbits were treated with 0.5 mL aliquots of neat tetrahydrofuran under occlusion. The primary irritation index obtained from this study was 1.93, indicating tetrahydrofuran was not irritating under the conditions of this study. In a guideline acute dermal toxicity study in rats (see Sect. 7.2.3), treatment for 24 hours under semiocclusive wrap at 2000 mg/kg bwt produced no reported effects on the skin.

Eye Irritation

In a key study conducted by the method of Draize, a 0.1 mL aliquot of undiluted tetrahydrofuran was placed into the eyes of 6 albino rabbits and observations of eye irritation were conducted for up to 7 days. Eyes remained unwashed for 24 hours. Based on calculated mean occular irritancy scores, tetrahydrofuran was a moderate eye irritant when administered to rabbits. The maximum mean ocular irritancy score was obtained on Day 2 (31.2). However, 2/6 rabbit eyes in this study displayed corneal opacity scores of 4 after 7 days. Further signs of irreversible eye effects in these treated animals included connective tissue deposition in the eyes.  In a supporting study conducted according to the Federal Hazardous Substances Act, 2/6 rabbit eyes displayed irreversible corneal damage after a 14 -day observation period.


Effects on eye irritation: highly irritating

Justification for classification or non-classification

Skin irritation

Based on the results of the key study (Primary Irritation Index of 1.93), tetrahydrofuran would not be rated a primary dermal irritant under the EU DSD criteria (EU Directive 67/548/EEC). Tetrahydrofuran would also not be classified for skin irritation under the EU CLP criteria (EU Regulation 1272/2008).

Eye irritation

Based on the results of the key study, tetrahydrofuran would be classified as Xi;R41 (Risk of serious damage to eyes) under the EU DSD criteria (EU Directive 67/548/EEC). This rating is based on severe and possibly irreversible effects on the eye. In the case of the EU CLP criteria (EU Regulation 1272/2008), tetrahydrofuran would be rated Category 1 (Serious eye damag/eye irritation).