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Carcinogenicity

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No carcinogenicity study is available for tert.-Butylperoxy- 2-ethylhexanoat.
Annex X, Column 2, Sect. 8.9.1 of the REACh Regulation states as follows:
"A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if:
- the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and
- the substance is classified as mutagen category 3 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
If the substance is classified as mutagen category 1 or 2, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not required. "

Tert.-Butylperoxy- 2-ethylhexanoat has no widespread use and tert.-Butylperoxy- 2-ethylhexanoat showed no indication for mutagen effects in vivo. A carcinogenicity study could not be justified scientifically and not in line with animal welfare. The need of conducting a study will be reconsidered in case of preneoplastic lesions observations after completion of the 90-day study.

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