Registration Dossier

Administrative data

Description of key information

The test article does not show acute toxicity when administered to rats by the oral, dermal oder inhalative route. The LD50 values were >6400 mg/kg and >2500 mg/kg body weight for oral and dermal route, respectively. No mortalities were reported in an inhalation risk test.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 400 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
7 390 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw

Additional information

Oral toxicity

In an oral toxicity study comparable to OECD guideline 401, Sprague-Dawley rats (5/sex/dose) were administered the test substance at dose levels of 3200 and 6400 mg/kg bw by gavage followed by a 7-day observation period. None of the animals died during the exposure period. No clinical signs were observed. Slight decrease in weight towards the end of observation period was recorded. No abnormalities observed during gross pathology. The LD50 was > 6400 mg/kg bw.

Inhalation toxicity

An inhalation risk test, which demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components, was performed with the test article. The nominal concentration is calculated as quotient of the amount of the test substance weight loss during exposure. 6 male and 6 female rats were exposed to the dusts for 8 h. None of the animals died during the exposure period and no abnormal clinical signs were reported. Body weights and gross pathology were normal. Average concentration of the test article in the atmosphere was determined as 7.39 mg/l.

Dermal toxicity

In a dermal acute toxicity comparable to OECD guideline 402, 5 Sprague-Dawley rats of each sex were treated with the test substance at 2500 mg/kg bw by single dose followed by a 14-day observation period. None of the animals died during the exposure period. No abnormal clinical observations were observed and no abnormal findings were reported during necropsy. The LD50 was >2500 mg/kg bw.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.