Registration Dossier

Administrative data

Description of key information

Oral: OECD 425; rat LD50 was >5000 mg/kg. Reliability = 1
Dermal: OECD 402; rat LD50 was >5000 mg/kg. Reliability = 1
Inhalation: OECD 403; rat LC50 was >5.06 mg/L (>5060 mg/m3). Reliability = 1

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
OECD Guideline, GLP study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
5 060 mg/m³
Quality of whole database:
OECD Guideline, GLP study

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
OECD Guideline, GLP study

Additional information

The test substance has low oral, inhalation, and dermal toxicity in the rat. The rat oral and dermal LD50s were >5000 mg/kg body weight. The only clinical sign observed was reduced faecal volume in one rat on Day 1 of the oral study. No other effects in clinical signs, body weight, or gross necropsy were observed in either study. The rat 4-hour inhalation LC50 was >5.06 mg/L, the highest concentration tested. Following exposure, all animals exhibited irregular respiration, but recovered by Day 2. Some rats exhibited weight loss on day 1. No other effects were observed during the study or at gross necropsy.

Justification for classification or non-classification

Based on oral and dermal LD50s in rats of >5000 mg/kg, and a 4-hour inhalation LC50 in rats of >5.06 mg/L, no classification is required for acute toxicity endpoints according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) regulation (EC) No. 1272/2008.