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Toxicological information

Carcinogenicity

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Description of key information

The following study has been submitted to address the carcinogenicity endpoint:
EFSA (2004) Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the Commision to assess the health risks to consumers associated with exposure to organotins in foodstuffs (Question No EFSA-Q-2003-110). The EFSA Journal 102: 1-119.
As the reference is secondary literature, it has been allocated a Klimisch score of 4.

Key value for chemical safety assessment

Additional information

No data is available for DBT(2 -EHMA) itself. Limited data from a presumably robust study indicated dibutyltin diacetate not to be carcinogenic in mice or in male rats; data for female rats was compromised by loss of tissues and no conclusion can be drawn.

A read-across approach was considered appropriate between dibutyltins. Under gastric conditions dibutyltins are hydrolysed to form dibutyltin chloride. This is demonstrated in various dibutyltin compounds presented in the TNO report V5047, (presented as individual reports as under Toxicokinetics).

Justification for classification or non-classification