Registration Dossier

Administrative data

Description of key information

See discussion section.

Key value for chemical safety assessment

Additional information

In NTP TR 275 a summary is given of avaialable literature on acute toxicity (page 16 -17):

"2-Chloroethanol is toxic when administered to laboratory animals at the concentrations and by the routes shown in Table 1. 2-Chloroethanol is

highly irritating to mucous membranes but produces little if any reaction upon contact with rabbit skin. It is not a sensitizer in the guinea pig test. Toxic amounts can be absorbed through the skin without causing dermal irritation (Gleason et al., 1969). Toxic reactions in humans exposed to 2-chloroethanol dermally or by inhalation were first reported by Koelsch (1927). Human fatalities have resulted from ingestion, inhalation, or dermal contact with 2 - chloroethanol (Goldblatt and Chiesman, 1944; Bush et al., 1949; Ballotta et al., 1963; Saitanov and Konanova, 1976). In all cams, neurotoxic symptoms were described. Death was attributed to cardiac and respiratory collapee. Guess (1970), in a study of the response of rabbit

tissues, showed that mucosal tissue was more sensitive to 2-chloroethanol than to ethanol; edema and erythema were produced by both. Of

particular interest in this study were tissues that might come in contact with ethylene oxide sterilized plastic devices used in medical or surgical procedures, devices that might contain residues of 2-chloroethanol. On intracutaneous administration, 2-chloroethanol was more toxic than ethanol; a 1: 10 dilution caused hemorrhagic reactions within 15 minutes, and affected areas became necrotic within 24 hours. Histologic examination showed localized edema, cellular destruction, and infiltration by polymorphonuclear leukocytes and lymphocytes.

Kronevi et al. (1979) studied the effects of several industrial solvents on the skin of guinea pigs. Exposure of guinea pig skin to 2-chloroethanol

produced pyknosis of the basal cell nuclei; severity progressively increased and all epidermal layers were affected. Perinuclear edema was progressive, and cytoplasmic vacuolization occurred after 16 hours' exposure. The livers of animals administered 2-chloroethanol showed centrilobular hydropic changes characterized by large, clear spaces in the cytoplasm. Similar but less severe skin changes were induced

by carbon tetrachloride, hexane, or toluene."

Justification for classification or non-classification

2 -chloroethanol is classified as " R26/27/28 Very toxic by inhalation, in contact with skin and if swallowed" according to Directive 67/548/EEC Annex I. This will be replaced by the classification according to Regulation (EC) 1272/2008 (CLP) Annex VI.

"Acute Tox. 2, H330 Fatal if inhaled"

"Acute Tox. 1, H310 Fatal in contact with skin" "Acute Tox. 2, H300 Fatal if swallowed"