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Carcinogenicity

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Description of key information

There is no information available for the multiconsituent substance itself, this study is waived. For one of the of the two major consituents, 40% is bis(2-chloroethoxy)methane CAS 111 -91 -1, carcinogenicity has been studied.

Under the conditions of these 2-year dermal studies, there was no evidence of carcinogenic activity of bis(2-chloroethoxy) methane in male or female F344/N rats administered 75, 150, or 300 mg/kg. There was no evidence of carcinogenic activity of bis(2-chloroethoxy) methane in male B6C3F1 mice administered 150, 300, or 600 mg/kg or in female B6C3F1 mice administered 100, 200, or 400 mg/kg.

Administration of bis(2-chloroethoxy) methane for 2 years resulted in increased incidences of nonneoplastic lesions in the nose of male and female rats, the forestomach of male rats, the heart of male and female mice, and the forestomach and skin of male mice.

The LOAEL for degeneration of the olfactory epithelium and inflammation and ulcers of the forestomach in rats is 75 mg/kg bw/day. In the report (NTP TR 536, 2011) these effects are not explained. It seems unlikely that these effects have occurred via the dermal application of the test substance. However in the report no specific details on the application of the test substance on the skin can be found. If the study was performed in line with the general NTP protocol this means that the treatment was left area uncovered. In toxicokinetic studies it has been shown that up to 50% of the total dose volatilized from the skin of some animals during 24-hour experiments (Black 2007). It therefore could the animals have ingested and/or inhaled the test substance leading to these effects.

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

There is no information available for the multiconsituent substance itself, this study is waived. Under the conditions of 2 -year dermal studies in rats and mice, there was no evidence of carcinogenic activity of the major consituent CAS 111 -91 -1, bis(2-chloroethoxy)methane.