Kommentarer sendt til Det europæiske Kemikalieagentur i forbindelse med den offentlige høring på det tyske dossier for 4-tert-octylphenol. Dette kan påvirke optagelsen af de første hormonforstyrrende kemikalier på kandidatlisten
(A) General comments
Overall, the Danish Ecological Council support the Annex XV dossier, and we agree that 4-tert-octylphenol is an endocrine disruptor and should be included on the candidate list as a SVHC of an equivalent level of concern (article 57f). However, we do not agree that 4-tert-octylphenol is only an endocrine disrupter in the aspect of ecotoxicology but believe that it is also of concern for human health, which is amplified by its occurrence in wide spread applications, whereas many are close to consumers. Therefore we argue, that the conclusion should be amended.
There are new data for endocrine disrupting effects of the substance from different test systems and species (e.g. in vitro studies, fish, and rodents) that indicate that 4-tert-octylphenol acts as an endocrine disrupter mainly through the estrogen receptor, which is present in a wide variety of species, including humans.
In conclusion, we argue that both environmental and human health concerns should be reflected in the conclusion of the dossier regardless of whether the evidence originates from ecotoxicity or toxicity studies. Since these considerations might have an impact on further considerations regarding possible Authorizations, it is very important that they get generally accepted. It will furthermore influence the future possibility to regulate combined exposure to endocrine disrupters.
We do not agree in the conclusion “4-tert-octylphenol does not represent a substance with ED properties of strong potency for the mammalian system” (page 155).
In the dossier it is indeed acknowledged that many studies indicate that 4-tert-octylphenol is an endocrine disrupter, and it is concluded “that 4-tert-octylphenol features some inherent potential for being toxic for reproduction, probably in relation to female sexual maturation and female fertility” (page 153). So with the available evidence we emphasis the importance of a clear statement that 4-tert-octylphenol should be measured as having ED properties, also for humans.
In the dossier, important data are excluded as applicable, such as effects induced through subcutaneous or interperitoneal routes of exposure (page 154). These data should instead be included in the overall weight of evidence for effect on human health, considering that these routes of exposure could indicate effects induced through dermal exposure or in some cases inhalation.
Lately (Feb. 2011), a paper shows that spermatogenesis is blocked at the round spermatid stage in high-dose exposed mice, subcutaneously injected with 4-tert-octylphenol. This further indicates, that data from subcutaneous exposed animals are important to include.
Since 4-tert-octylphenol is found in a wide variety of consumer articles such as clothing, we argue that both dermal and inhalation exposure routes should be taken into consideration. It says in the dossier “results summarized in (Environment Agency UK, 2008) showing that octylphenols were found in nearly all analyzed imported colored textile articles”.