Registration Dossier

Administrative data

Description of key information

- Acute oral toxicity (OECD guideline 401): LD50 > 5000 mg/kg bw (CIBA-GEIGY Ltd., 850040, 1985)
- Acute dermal toxicity (OECD guideline 402): LD50 > 2000 mg/kg bw (CIBA-GEIGY Ltd., 850043, 1985)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute oral toxicity

The acute oral toxicity of the test substance was assessed in rats following OECD guideline 401 (CIBA-GEIGY Ltd., 850040, 1985) and under GLP-like quality controlled conditions. In the limit test, a single dose of 5000 mg/kg body weight in distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 was applied once by gavage to five male and five female rats following an observation period of 14 days. No mortality occurred within the timeframe of the study. Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. The animals recovered within 13 days. Body weight gain was normal and necropsy did not reveal any abnormalities. Overall, under the chosen test conditions, the test substance was not toxic after single oral administration: Oral LD50 > 5000 mg/kg body weight

Acute dermal toxicity

As a second exposure route acute dermal toxicity was investigated (CIBA-GEIGY Ltd., 850043, 1985). In the study according to OECD guideline 402 and under GLP-like quality assurance, the Standard Acute Method using a single dose of 2000 mg/kg body weight (vehicle: distilled water containing 0.5%carboxymethylcellulose and 0.1% polysorbate 80) in a limit test was performed using five male and five female rats. The rats were treated semi-occlusively for 24 hours and then observed for 14 consecutive days. No mortality occurred within the timeframe of the study. Clinical signs were limited to dyspnea, ruffled fur, and abnormal body positions, being common symptoms in acute tests. Additionally, diarrhea was observed on day 1 after application. All animals recovered within 13 days. Body weight gain was normal and no deviations from normal morphology were found at autopsy. Overall, under the chosen test conditions, the test substance does not have toxic properties in case of single dermal exposure: Dermal LD50 > 2000 mg/kg body weight.

Acute inhalation toxicity

No data available.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for acute toxicity is not warranted under Directive 67/548/EEC.

 

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.