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Administrative data

Description of key information

Acute toxicity:
Oral (OECD 423), rat: LD50 ≥ 5000 mg/kg bw (LD50 cut-off value)
Dermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw (limit test)
Inhalation (OECD 403), rat: LD50 > 3513 mg/m³ (limit test)

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
3 513 mg/m³

Acute toxicity: via dermal route

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

Additional information

The acute oral toxicity study was performed in accordance with OECD 423 (Schüngel, 2005). The the substance formulated in tap water with 2% Cremophor EL was administered by gavage to rats in a dose of 2000 mg/kg bw. There were no deaths or signs of toxicity during the study. Gross examination of organs and tissues at necropsy did not reveal any abnormalities. According to OECD 423, the LD50 cut-off value of the test substance was 5000 mg/kg bw.

 

According to OECD 402, 2000 mg/kg bw of the test substance was dermally applied to the intact skin of rats (Schüngel, 2005). The test substance was placed on a wet gauze patch and applied to the skin for 24 h under semi-occlusive conditions. After the exposure period, the gauze patch was removed and the treated skin was rinsed and dried. There were no deaths or signs of toxicity during the study. Gross examination of organs and tissues at necropsy did not reveal any abnormalities. The LD50 of the test substance was > 2000 mg/kg bw.

 

The acute inhalation toxicity of the test substance on rats was conducted in accordance with OECD 403 (Pauluhn, 2004). The rats were nose-only exposed to a mean solid aerosol concentration (powder) of 3513 mg/m³. The aerosol generated was respirable to the rats (MMAD 3.2 µm, GSD 1.8). The maximum achievable concentration of 3513 mg/m³ did not cause mortality. Nonspecific clinical signs were observed in some females without indication of a treatment-relationship. There were no effects on body weight development. Gross examination at necropsy did not reveal any abnormalities. The LC50 of the test substance was > 3513 mg/m³.

Justification for classification or non-classification

The available data on acute toxicity (oral, inhalation and dermal) of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.