Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

Acute oral toxicity

There are 2 studies available in which the oral toxicity is assessed. The study result available in the Quaker Oat bulletin was used to derive the classification, since the data was judged to be more reliable than that of Marhold.

The Quaker Oat bulletin reports a LD50 value of 133 mg/kg bw. According to the EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) the substance should hence be classified as acute toxic via oral route, cat. 3, because the LD50 is in the range of 50 - 300 mg/kg bw (Table 3.1.1).

Acute inhalation toxicity

There are 3 studies available in which the inhalation toxicity is assessed. The most comprehensive and reliable study available is the study by Terril et al. (1989). This study was used to derive the classification.

The Terril et al. study reports a LC50 value of 1488 ppm after 1h exposure. Since it concerns a vapour, this value was divided by 2 to derive the 4h exposure equivalent. The LC50 is hence 742 ppm or 2.48 mg/L. According to the EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) the substance should hence be classified as acute toxic via inhalation, cat. 3, because the LC50 is in the range of 2 - 10 mg/L (Table 3.1.1).

Acute dermal toxicity

There is one study in which the acute toxicity via dermal route has been assessed, i.e. the Quaker Oat bulletin. The reported LD50 value is 1600 mg/kg after 24h exposure to the undiluted substance. According to the EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) the substance should hence be classified as acute toxic via dermal route, cat. 4, because the LD50 is in the range of 1000- 2000 mg/kg bw (Table 3.1.1).

However, it is to be noted that in this study the test material was administered percutaneous. Hence, the reported LD50 value is most likely an overestimation of the toxicity. The classification is hence considered to be conservative.