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Description of key information

Acute oral toxicity

A study was carried out according to the Chinese guidelines for the testing of chemicals (similar to OECD-guideline no. 401) on Albino Wistar rats. Dose groups of 100, 215, 464 and 1000 mg/kg were tested (5 male, 5 female per dose group). The test item was dissolved in peanut oil. and administered orally by gavage. 0% mortality was noted at 100 mg/kg, 20% at 215 mg/kg and 100% at 464 mg/kg and above. Clinical symptoms included dispirited prostration, ruffled fur, bloody secretion in nose and dirty perineum 48 hours after administration. Mortality occured between days 2 and 7. Surviving animals recovered within days 4 -6. In conclusion, the acute oral LD50 on rats was calculated to be 271 mg/kg.

Further studies are available on rabbits, mice and rats; their LD50 are in the range of 46-500 mg/kg. However, quality of these studies is rather low and therefore the tests were not further evaluated.

Acute inhalation toxicity

A study was carried out according to the Chinese guidelines for the testing of chemicals (similar to OECD-guideline no. 403) on Wistar rats. Animals were exposed to test item vapor for 4 hours at concentrations of 1.00, 2.15, 4.64 and 10:00 mg/l. After administration, rats were observed fpr 14 days. Symptoms of prostration, sweating, lying, bloody secretions in mouth and nose, sthma, perineal secretions were noted in males and females after administration. Mortalities occured within 24 hours, whereas the surviving animals gradually recovered between days 2 and 6.. In conclusion, the acute inhalative LC50 was 4.30 mg/l.

Acute dermal toxicity

A study was carried out according to EU Method B.2 and OECD Guideline 402 (Acute Dermal Toxicity) on Albino Wistar rats. Dose groups of 50, 400 and 2000 mg/kg were tested (5 male and 5 female at 50 mg/kg, 2 females only at 400 and 2000 mg/kg). The test item was suspended in maize oil and administered dermally for 24 hours. 0% mortality was noted at 50 mg/kg, 50% at 400 mg/kg and 100% at 2000 mg/kg. Clinical symptoms included sluggishness, hunching, blepharospasm, pallor and vocalization. Skin effects observed consisted of erythema, encrustations and oedema. Macroscopic examination of surviving animals at the end of the observation period did not reveal any abnormalities. The acute dermal LD50 was therefore considered to be between 50 and 400 mg/kg in both males and females.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
271 mg/kg bw
Quality of whole database:
Guideline study; Klimisch 2 (non-GLP)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
4 300 mg/m³ air
Quality of whole database:
Guideline study; Klimisch 2 (non-GLP)

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
Guideline study; Klimisch 1 (GLP)

Additional information

Justification for classification or non-classification

Based on the results of the two studies, the test item needs to be classified as follows:

Acute toxicity cat.3; oral - H 301: Toxic if swallowed

Acute toxicity cat.2; dermal - H 310: Fatal in contact with skin