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Toxicological information

Carcinogenicity

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Description of key information

In a limited 94-week carcinogenicity study, no differences in tumor incidence were observed between controls and male rats administered 1% DIPA via the diet. In addition, the substance is not mutagenic and no hyperplasia and/or pre-neoplastic lesions were observed in the oral semichronic repeated dose toxicity study.

Key value for chemical safety assessment

Mode of Action Analysis / Human Relevance Framework

No information available.

Additional information

A 94-week dietary study with 0 or 1% DIPA in the feed was conducted using 20 male Wistar rats (Yamamoto et al., 1989). Sixteen of twenty animals survived in the treatment group. Intakes of feed and water were evaluated daily and were constant throughout the study. No treatment-related effects on body weight were observed. Histopathological examination was conducted for all major organs with no significant differences between tumor incidence in controls or treated groups reported.

However, exposure by male Wistar rats to both 1% DIPA in the diet plus 0.15 or 0.3% sodium nitrite in drinking water resulted in nasal and lung tumors with incidences of 74 and 58% in rats given 1% DIPA and 0.3% sodium nitirite. N-nitroso compounds [N-nitroso-diisopropanolamine at 24, 34 and 80 weeks; N-nitroso(2-hyroxypropyl)(2-oxopropyl)amine at 24 and 34 weeks were also excreted in urine after exposure to DIPA and 0.3% sodium nitrite (Yamamoto et al.,1989). Only limited details are available for this study.

The substance is not mutagenic and no hyperplasia and/or pre-neoplastic lesions were observed in the oral semichronic repeated dose toxicity study with DIPA.

Justification for classification or non-classification

Based on the results of a 94-week carcinogenicity study with 1% DIPA in the diet, the absence of hyperplasia and/or pre-neoplastic lesions in the oral semichronic repeated dose toxicity study and the negative in vitro genotoxicity studies, DIPA is considered to be non-carcinogenic; therefore classification according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is not warranted.