Registration Dossier

Administrative data

Description of key information

Oral: OECD425; rat LD50 =3129 mg/kg. Reliability = 1
Dermal: OECD 402; rat LD50 >5000 mg/kg. Reliability = 1
Inhalation: OECD 403; rat 4-hr LC50 >2.6 mg/L non-volatile components. Reliability =1

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 129 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Additional information

The substance has low inhalation, oral, and dermal toxicity in the rat. The rat 4-hour inhalation LC50 is >5.6 mg/L (total atmospheric concentration) and >2.6 mg/L (non-volatile components). One rat exhibited laboured breathing after removal from the exposure chamber on the day of dosing and body weight loss was observed on day 1.The rat oral LD50 was 3129 mg/kg, with clinical signs observed in rats at ≥1750 mg/kg including ataxia, decreased muscle tone, laboured breathing, clear ocular discharge, low or prostrate posture, mydriasis, and/or moribundity. The dermal LD50 was >5000 mg/kg body weight, with no observed clinical signs of toxicity.


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

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

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

Justification for classification or non-classification

The acute oral LD50 in the rat was 3129 mg/kg/bw, the acute dermal LD50 in the rat was >5000 mg/kg, and the 4-hour inhalation LC50 in the rat was >2.6 mg/L non-volatile components. No animals died following the 4-hour exposure to the limit concentration of 2.6 mg/L non-volatile components, the maximum achievable for the non-volatile components based upon testing of the product at the limit concentration. Based on these results, the substance does not need to be classified for acute toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.