Registration Dossier

Administrative data

Description of key information

Oral: OECD401; LD50, rat. The LD50 was >5000 mg/kg. No adverse effects observed. Not classified as acutely toxic by the oral route. Reliability = 1
Dermal: OECD 402; LD50, rat. The LD50 was >5000 mg/kg. No adverse effects observed. Not classified as acutely toxic by the dermal route. Reliability = 2.
Inhalation: OECD 403. 4-hr LC50, rat. The LC50 was 114428 mg/m3 air. No adverse local effects observed. Acute toxicity (central nervous system) observed at 50307 mg/m3. In a special rat, 2-hr inhalation study, central nervous system effects were observed at 25772 mg/m3, but not at 15463 mg/m3. Not classified as acutely toxic by the inhalation route. Reliability =1

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
discriminating conc.
15 463 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
5 000 mg/kg bw

Additional information

Toxicity Description: The substance has low inhalation toxicity with a rat 4-hour LC50 value of 114428 mg/m3. During inhalation to substance concentrations of 25772 mg/m3 and higher, acute toxicity was associated with central nervous system effects, which were observed as intermittent convulsions.

 

Dose-response relationship: The acute central nervous system effects were associated in a dose-related manner, with exposure concentrations of 25772 mg/m3 and higher. Exposure concentration, not exposure duration, was the determinant as to whether or not central nervous system effects occurred in the inhalation toxicity studies. Convulsions and central nervous system effects were similar to those observed in the 90-day repeated inhalation study, and in the other repeated inhalation exposure studies. Systemic activity was not observed with oral and dermal routes of exposure.

 

Dose Descriptor: NOAEL for central nervous system effects resulting from acute inhalation exposure was 15463 mg/m3(1500 ppm).

Justification for classification or non-classification

Based on the rat 4-hour LC50 of 114428 mg/m3 and the observations during the acute inhalation exposure, the substance does not need to be classified for acute toxicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.