Registration Dossier

Administrative data

Description of key information

2 -chloroethanol is listed in Annex VI of Regulation 1272/2008 as very toxic in contact with skin. Thus, testing for skin or eye irritation is not required. Nevertheless, the test item caused slightly irritating effects to rabbit skin, whereas the acute dermal toxicity is prevaling. Furthermore, the test item caused severe irreversible effects to the eyes of rabbits.

Key value for chemical safety assessment

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

According to Regulation 1907/2006/EC (REACH Regulation) substances classified as very toxic in contact with skin do not need to be tested for eye irritation/skin irritation or corrosion in vivo. As 2 -chloroethanol is listed in Annex VI of Regulation 1272/2008 as very toxic in contact with skin testing for skin or eye irritation is not required. Nevertheless, the available information regarding these endpoints is summarised below.

In two acute dermal irritation studies (Guess, 1970; Lawrence, 1971) the application of 0.2 ml undiluted test substance showed only slight, transient erythema or rather no irritant effects in rabbits. A study conducted by BASF (1973) demonstrated slight irritating effects after an exposure period of 15 min when a patch (2.5 x 2.5) loaded with 2 -chloroethanol was applied to the back of the rabbit. Irritant effects after an exposure period of 20 h could not be examined since animals died overnight.

In a human study (Shupack, 1981) 11 out of 13 volunteers did not show irritating effects after application of 1.1% test substance in unknown vehicle. In two studies (Guess, 1970; Star, 1980) the undiluted as well as the diluted (20 %) test substance caused irritation to the penil mucosa.

In an eye irritation study (BASF, (1973)) 60 mg test substance was instilled into the right eye of rabbits; the left eye served as control (physiological saline instilled). No effects were detected in the control eyes whereas irreversible damage occurred in the treated eye in both rabbits. In conclusion, the undilute test item caused irreversible damage on the eyes in rabbits. Furthermore, in an eye irritation test (Draize test, Guess et al., (1970)) on 6 rabbits the undiluted test substance resulted in serious damage to the eyes. Three additional studies (Lawrence et al., (1971); Star et al., (1980); Mc Donald et al., (1972/73) demonstrated irritating effects on the rabbit eye.


Effects on eye irritation: highly irritating

Justification for classification or non-classification

2-Chloroethanol is listed in Annex VI of Regulation 1272/2008 as very toxic in contact with the skin. For such substances no testing for skin irritation is needed acc. to Regulation 1907/2008 and consequently classification with regard to skin irritation is not required.

Based on the results obtained in eye irritation study with rabbits the test substance has to be classified with respect to eye irritation, Xi; R41 "Irritant; Risk of serious damage to eyes" according to Directive 67/548/EEC (DSD) and cat. 1, H318 "Causes serious eye damage" according to Regulation (EC) No 1272/2008 (CLP, GHS).