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Description of key information

Key value for chemical safety assessment

Additional information

There are no specific toxicokinetic studies available with the test substance. Therefore, the following assessment of the toxicokinetic behavior is based on the physicochemical properties of the test substance and the results from existing toxicological studies with the test substance.

 

Relevant physicochemical properties of the substance:

- substance is a mixture of several components

- substance is a beige colored waxy solid (at 20°C and 1013 hPa)

- volatility is negligible

- molecular weight: 386.619 g/mol

- logPow: The estimated log Pow for the two main components ranges between 12.7 and 20.9

- water solubility: 6 - 15 mg/L at 20°C

 

Interpretation of data from acute toxicity studies and repeated dose toxicity (RDT) studies:

There are data on acute oral toxicity in rats (LD50 > 2000 mg/kg bw; BASF SE, 2007) and acute dermal toxicity in rats (LD50 > 2000 mg/kg bw; BASF SE, 2009). There are also data on oral RDT available, with a NOAEL (rat) for general systemic toxicity = 100 mg/kg bw/d (BASF SE, 2010). After single oral application no signs of systemic toxicity were observed. However, after repeated oral application signs of systemic toxicity were observed indicating absorption of the test substance by this exposure route. After single dermal application no mortalities, clinical effects, specific target organ toxicity or any other changes were observed. This result is suggestive of a limited dermal absorption of the test substance.

According to the Danish (Q)SAR Database (EPI Suite, DERMWIN v2.09) and supporting to the lack of systemic effects in the acute toxicity study with dermal application, the dermal absorption of the test substance is estimated to be low with an estimated Kp value of 0.00251 cm/hr. In contrast, the sensitizing effect observed in a Local Lymph Node Assay with dermal application in mice (BASF SE, 2009) proved a certain dermal penetration of the test substance or metabolites thereof.

The estimated log Pow for the two main components ranges between 12.7 and 20.9. The BCF of a substances is probably low if the calculated log Pow is higher than 10 [Guidance on information requirements and chemical safety assessment Chapter R.11]. In case of the test substance this prediction is confirmed by estimated BCF values which range between 3 and 19 for the two main components (Epiwin BCFBAF Program v3.00). Furthermore, a short retention time can be expected, due to the ready biodegradability of the mixture. Taken together, significant accumulation of the substance in organisms is not to be expected.