Registration Dossier

Administrative data

Description of key information

300 mg/kg < LD50 (rat, oral) < 2000 mg/kg

LD50 (rat, dermal) > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity

The acute toxicity of the test item was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period. A first group of 3 female animals was initially dosed at 2000 mg/kg body weight. Mortality occurred in all animals on Day 2. Hunched posture, piloerection and decreased activity were observed on the day of dosing. A second group of 3 female animals was then dosed at lower dose level of 300 mg/kg. No death occurred and no signs of toxicity were seen. A third group of 3 female animals was then dosed at the same dose level (300 mg/kg). No death occurred and no signs of toxicity were seen. No abnormalities were observed at necropsy examination in the early decedent animals and in those sacrificed at the end of the observation period. These results indicate that the test item induced effects of toxicological relevance (mortality) in the rat following oral administration of a single dose at 2000 mg/kg. No mortality nor signs of toxicity were observed following dosing at 300 mg/kg.

300 mg/kg < LD50 (rat, oral) < 2000 mg/kg

Acute inhalation toxicity

Not evaluated considering that the vapour pressure of the substance suggests that the inhalation exposure is unlikely to occur.

Acute dermal toxicity

The acute toxicity of the test material was investigated following dermal administration of a single dose to the rat, according to the OECD Guideline 402. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours, under semi-occlusive dressing. Animals were observed for mortality and clinical signs and were weighed on the day of allocation, on the day of dosing and on days 8 and 15. After 14 days, all animals were killed and subjected to necropsy examination. No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. The body weight changes observed during the study were within the expected range for this species and age of animals. No significant abnormalities were found at necropsy in the animals at termination of the study. No abnormalities were observed at the treated site.

LD50 > 2000 mg/kg

Justification for classification or non-classification

According to the CLP Regulation (EC) No.1272/2008 Annex I: 3.1.2.1.: "Substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE)."

The LD50 obtained in the acute dermal toxicity study is above 2000 mg/kg bw and therefore no classification applies. However, the LD50 obtained in the acute oral toxicity is between 300 mg/kg bw and 2000 mg/kg bw and for this reason the substance is classified in Category 4 (H302) according to the CLP classification criteria.