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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.

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.

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.