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Administrative data

Description of key information

Acute oral LD50: 2875 mg/Kg (95% C.I: 2614 – 3162 mg/Kg).

Acute Dermal LD50: >2000 mg/Kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
2 875 mg/kg bw
Quality of whole database:
One key pre-guideline acute oral toxicity study in rats available for assessment.

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
Quality of whole database:
One key Guideline (OECD 402) acute dermal toxicity study in rats available for assessment.

Additional information

Acute Oral Toxicity

In a key pre-guideline acute oral toxicity study, the test material was administered via intragastric intubation to Charles River CD rats (10 males/dose) at doses of 2250, 2630, 3020, 3400, or 5000 mg/Kg. Animals were observed for clinical signs and gross pathologic changes with surviving animals sacrificed 14 days post exposure.

 

Mortality was observed at each dose level as follows: 2250 mg/Kg (1/10); 2630 mg/Kg (2/10); 3020 mg/Kg (7/10); 3400 mg/Kg (8/10); 5000 mg/Kg (10/10). Clinical signs observed through the study period included pallor, discomfort, belly-crawling after dosing, weight loss for 1-2 days, diarrhoea, stained ventral area as well as hematuria observed at the two higher doses.

 

Dark bone marrow, hyperemic thymus, stomach and intestine distended with fluid, and hemorrhagic intestine and glandular mucosa of the stomach were observed in animals that died (5). In animals that survived (8), thickened stomach mucosa and, at higher dose levels, adhesion of the liver to the stomach were observed. 

 

Based on mortality and clinical signs of toxicity as well as gross pathology observed in the study, the acute oral LD50 (calculated using the Litchfield and Wilcoxon method (1949)) was determined to be 2875 mg/Kg (95% C.I: 2614 – 3162 mg/Kg).

 

Acute Dermal Toxicity

In a key Guideline (OECD 402) acute dermal toxicity study, the test material was dermally administered to Sprague-Dawley rats (5/sex/dose) at a single dose of 2000 mg/Kg for a period of 24 hours under semi-occlusive conditions. Post exposure, the adhesive bandage and gauze patch were removed and the treated area (dorsal surface of the trunk of each anima) was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water. The animals were subsequently observed for a period of 14 days. On Day 15, all animals were sacrificed and subjected to gross necropsy examination for both external and internal abnormalities.

 

No mortality was observed through the study period. Slight to moderate scabs on the treatment site (dorsal region) were observed in several animals from Day 4. These had completely recovered by the end of the observation period in all animals, with the exception of three females (nos. 1, 3, and 7), that showed scabs on the treatment site also on the day of necropsy.

 

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. Scabs in three female animals (nos. 1, 3 and 7) were observed at the treated site.

 

These results indicate that the test material has no toxic effects on the rat following dermal exposure over a 24 hour period at a dose level of 2000 mg/Kg. Based on the lack of mortality, the acute dermal LD50 was determined to be >2000 mg/Kg.

Acute Inhalation Toxicity

No studies were available for review. Exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Justification for classification or non-classification

Not classified for acute toxicity by the oral or dermal routes of exposure under CLP Regulation (EC 1272/2008), section 3.1.