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Toxicological information

Carcinogenicity

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Administrative data

Description of key information

In a limited 104-week dietary study, no histological evidence of increased liver foci was found in male rats in response to dietary administration of 2% TIPA. 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

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Mode of Action Analysis / Human Relevance Framework

No further details.

Additional information

A limited 104-week dietary study with 0 or 2% TIPA in the feed was conducted using 21 male Wistar rats per dose (Yamamoto et al., 1989). Additional groups (28 animals/dose) were co-treated with TIPA and 0.15% or 0.3% sodium nitrite (NaNO2). No preneoplastic GST-P-positive foci were observed in the liver of TIPA or TIPA and NaNO2 treated rats.

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

Justification for classification or non-classification

Based on the results of a 104-week dietary study with 2% TIPA, the absence of hyperplasia and/or pre-neoplastic in the oral semichronic repeated dose toxicity study and the negative in vitro and in vivo genotoxicity studies, TIPA 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.