Registration Dossier

Administrative data

Description of key information

Oral: OECD 425. discriminating dose, rat. The overall discriminating dose level was 50 mg/kg. Reliability = 1 
Dermal: OECD 402. LD50, rat. The LD50 was >2500 mg/kg. Reliability = 1
Inhalation: OECD 403. 4-hr LC50, rat. The LC50 was 1984 ppm (13396 mg/m3) in females and 3075 ppm (20762 mg/m3) in males. Reliability =1.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
discriminating dose
Value:
50 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
13 396 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 500 mg/kg bw

Additional information

The substance was evaluated for acute toxicity (lethality) via the acute oral, dermal and inhalation routes of exposure. The highest fixed dose in the oral study that did not cause lethality (i.e., the overall discriminating dose-level) was 50 mg/kg. In the rat acute oral toxicity study, no clinical signs of toxicity were observed at 50 mg/kg, but at higher doses, piloerection, sides pinched in, urine stains (wet and dry), stains around the nose and mouth, lacrymation, signs of salivation, tip toe gait, decreased activity, splayed gait, reduced stability, hunched posture, pale, and/or upward curvature of the spine were observed. In a rat acute dermal toxicity study, male and female rats were exposed to the test substance for 24 hours. No deaths occurred. The rats exhibited no clinical signs of systemic toxicity or body weight loss. No gross lesions were present in the rats at necropsy. The male and female rat dermal LD50 was greater than 2500 mg/kg. In a rat 4-hour acute inhalation study, the LC50 was 3075 ppm (20762 mg/m3) for male rats and 1984 ppm (13396 mg/m3) for female rats. Clinical signs of toxicity observed in all groups during exposure included wet fur, salivation, reduced response to sound, chromodacryorrhea, reduced breathing rate, lacrymation, and/or increased breathing depth. Observations observed after exposure included reduced reflexes, hypothermia, breathing problems, dehydration, lacrymation, wet fur, stains around the snout, piloerection, and/or salivation. Signs of toxicity had resolved by day 5 post exposure. No gross pathological findings were observed in rats that survived the 14-day post-exposure period.

Justification for classification or non-classification

In an acute oral toxicity study, severe toxicity was observed at 500 mg/kg, as well as moribundity preceding sacrifice in extremis (3/5 rats) at this dose. The discriminating dose (no mortality) for this study was 50 mg/kg. In an acute inhalation study, the 4-hour LC50 in rats was 13396 mg/m3 (1984 ppm). Based on the findings in the acute oral and inhalation studies, the test substance is classified as Xn, R20/22/ (harmful by inhalation and if swallowed) for acute toxicity according to EU Directive 67/548/EEC. The test substance is also classified as Cat 4 (harmful if swallowed) for acute oral and Cat 4 (harmful if inhaled) for acute inhalation, according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) regulation (EC) No. 1272/2008. 

Based on the dermal LD50 in rats of >2500 mg/kg, no classification is required for the acute dermal endpoint, according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) regulation (EC) No. 1272/2008.