Registration Dossier

Administrative data

Description of key information

LD0 (oral) > 1792 mg/kg (>2mls/kg)

LC0 (inhalation, 4 hrs) > 9.59 mg/L (represents approximately 22% of saturated vapour pressure.)

(analogue) methoxypropanol LD50 (dermal) >2000mg/kg

Key value for chemical safety assessment

Additional information

The acute toxicity of ethoxypropyl acetate is very low. The rat oral LDLo value is greater than 2.0 ml/kg (1792 mg/kg), and the rat inhalation LC0 value is greater than 9,590 mg/m3 (4-hour, nose only, vapour). No data is available for the dermal route on the substance itself, but based on an early acute dermal toxicity study in rabbits, the single dose LD50 for methoxypropanol (a close structural analogue of ethoxypropanol) applied to the occluded skin for 24-hours is greater than 2000mg/kg. A conclusion of low toxicity by the dermal route is also supported by a guideline and GLP acute dermal toxicity limit study on another close structural analogue ethoxypropoxy propanol , which did not cause any mortality at a dose of 2009mg/kg bw.

An extensive justification for read across is contained in the read across justification attached to chapter 13 of this dossier.

Justification for classification or non-classification

Available data shows that the substance ethoxypropanol has low acute toxicity by all routes of intake and therefore does not justify classification for acute toxicity. However, there is evidence to show that narcosis can occur following exposure to high concentrations and therefore use of the risk phrase R67 under directive 67/548 and classification STOT (SE) H336 is appropriate under the CLP regulation 1272/2008.