Registration Dossier

Administrative data

Description of key information

Inhalation: OECD 403; rat 4-hr LC50 >102900 ppm (>690413 mg/m3). Reliability =2

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
690 413 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an OECD 403 guideline study conducted under GLP conditions, one group of 5 male and 5 female Crl:CD(SD) albino rats were exposed nose-only to vapours of the substance for 4 hours at a concentration of 102900 ppm, the highest achievable vapour concentration. No mortality or significant clinical signs were observed during the exposure or the 14-day post-exposure observation period. There were no remarkable changes in body weight. Under the conditions of this study, the 4-hour LC50 in rats was greater than 102900 ppm (690413 mg/m3). 

In another GLP acute (approximate lethal concentration (ALC)) inhalation toxicity study, one group of 4 male Crl:CD(SD) rats were exposed whole-body for a single, 2-hour period to vapours of substance at 21000 ppm. No mortality was observed during the exposure or the 14-day recovery period. Irregular respiration was observed during exposure as well as a slight body weight loss (0.31% - 4.6%) on the day after exposure, followed by normal weight gain for the remainder of the recovery period. Under the conditions of this study, the 2-hour ALC in rats was greater than 21000 ppm (140902 mg/m3).


Justification for selection of acute toxicity – inhalation endpoint
OECD guideline, GLP study

Justification for classification or non-classification

Based on the inhalation 4-hour LC50 in rats of >102900 ppm (690419 mg/m3), no classification is required for acute inhalation endpoint according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.