UNDERLYING ARGUMENTATION Sample Clauses

UNDERLYING ARGUMENTATION. FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN A weight-of-evidence determination according to the provisions of Annex XIII of REACH is used to assess the PBT/vPvB properties of the substance. All available information (such as the results of standard tests, modelling and (Q)SAR results) was considered together in a weight-of-evidence approach. According to the ECHA guidance (ECHA 2017a, R.11), the Weight-of-Evidence determination by expert judgement enables the use of all (screening and assessment) information types listed in Section 3 of Annex XIII to the REACH Regulation in the PBT/vPvB assessment for comparing with the criteria, although not all of these information types can be directly (numerically) compared with the criteria.
Sample 1
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UNDERLYING ARGUMENTATION. FOR IDENTIFICATION OF SUBSTANCE OF VERY HIGH CONCERN Based on the data presented in the support document 1,2,4-Trichlorobenzene is persistent (P) as the criterion for persistency according to Xxxxx XXXX is met and it may be very persistent (vP) in sediments and soil. However, with regard to the bioaccumulation (B) and toxicity (T) criteria, such a conclusion cannot be drawn. Nevertheless the substance still has a significant bioaccumulation and toxicity potential to aquatic organisms. In addition, results of model calculations have shown a high long-range transport potential of the substance. The potential occurrence of serious effects in biota in remote and sensitive ecosystems was considered, taking into account the intrinsic properties of the substance. However, based on the information available in the support document, the comments received in the public consultation and the discussions in the Member State Committee, the Member State Committee agreed that it cannot be concluded that 1,2,4-Trichlorobenzene should be considered as a substance of very high concern in accordance with Article 57 (f).
Sample 1
UNDERLYING ARGUMENTATION. FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN Perfluorobutane sulfonic acid (PFBS) and its salts are identified as substances of very high concern in accordance with Article 57(f) of Regulation (EC) 1907/2006 (REACH) as there is scientific evidence of probable serious effects to the environment and human health which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 of REACH. Substance identification PFBS-salts are fully indistinguishable from PFBS in the environment as the salts exist in their dissociated anionic sulfonate form, just like PFBS itself, and they are all a part of an acid-base equilibrium in water. Hence, all conclusions on different end-points apply to any and all salt forms, as well as PFBS itself. Intrinsic properties of PFBS PFBS is very persistent in the environment. Based on the available data abiotic or biotic degradation of PFBS at relevant environmental conditions is expected to be very slow or negliglible. This is supported by read-across to perfluoroalkane sulfonic acids with both shorter and longer chain lengths, which also have a very low degradability. PFBS shows a preference for distribution to the aqueous phase due to its high solubility in water (52.6 g/L at 22.5-24 °C for the potassium salt), its low sorption potential (log KOC 1.2 to 2.7) and it is considered highly mobile in the environment. The very high persistence, together with low adsorption potential and high mobility, imply a very high potential for increasing environmental concentrations and potential irreversible exposures of wildlife and of humans via the environment. Long-term, low dose exposure may potentially lead to currently unexpected or even still unknown effects. In particular, endocrine disturbances may be of relevance when considering such exposure. PFBS is bioavailable via the aqueous environment. Together, these environmental fate properties lead to a high potential for irreversible effects. Furthermore, there are high costs and technical challenges related to the removal of PFBS using end-of-pipe treatment. The high global transport potential (characteristic travel distance, CTD 17616 km, POV = 220 days), is demonstrated by detection of PFBS in samples of surface water, snow, ice, air and marine water from remote areas such as the Arctic and the Antarctic. This is supported by scientific assessments of the mobility of PFBS, together with QSAR modelling data. PFBS has also been...
Sample 1
UNDERLYING ARGUMENTATION. FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN Persistence Based on the weight of evidence of the data available, it is concluded that Dechlorane Plus meets the criteria for vP in Annex XIII of REACH. This is based on: • modelling of degradation potential and microbial metabolic pathways which suggests that biodegradation is likely to be very slow; and • a low probability that it will degrade any faster than structural analogues that are considered to be very persistent under the Stockholm Convention. This conclusion is also supported by the very low water solubility (suggesting limited bioavailability to micro-organisms once bound to solid matrices), monitoring data indicating that the substance can persist in sediments (a major sink) for many years, lack of evidence of biotransformation in fish (supporting the premise that the molecule is metabolically recalcitrant) and widespread occurrence in remote regions.
Sample 1
UNDERLYING ARGUMENTATION. FOR IDENTIFICATION OF SUBSTANCE OF VERY HIGH CONCERN Persistence: The results of a biodegradation simulation study with both freshwater and marine sediment are available. Under aerobic conditions the mineralisation half- life was determined to be around 1,340 days for the C10, 65% wt. Cl substance in freshwater sediment, 335 days for the C10, 65% wt. Cl substance in marine sediment, 1,790 days for the C13, 65% wt. Cl substance in freshwater sediment and 680 days for the C13, 65% wt. Cl substance in marine sediment. The mean half-live (average of the two substances, this could be assumed to be representative of a C10-13, 65% wt. Cl product) was determined to be around 1,630 days in freshwater and 450 days in marine sediment. Based on the available data it is therefore concluded that Alkanes, C10-13, chloro (short chain chlorinated paraffins) meet the criteria for both a P substance and a vP substance.
Sample 1
UNDERLYING ARGUMENTATION. FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN Endocrine disrupting properties - Article 57(f): Human Health: Bisphenol A is identified as a substance of very high concern in accordance with Article 57(f) of Regulation (EC) 1907/2006 (REACH) because it is a substance with endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health which gives rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 REACH. Bisphenol A has a harmonised classification for the hazard class Reproductive toxicity category 1B (H360F ‘May damage fertility’) based on effects on reproductive function. BPA has been identified recently as SVHC according to Article 57(c) of REACH and included in the Candidate List by decision of ECHA ED/01/2017 of 4 January 2017. BPA has been shown to affect the reproductive function, mammary gland development, cognitive function and metabolism through pathways that commonly involve disruption of estrogenic regulation. The effects on female reproductive function include the induction, after both developmental and adult exposures, of cystic ovaries, changes in the uterus morphology, alteration of fertility parameters as well as estrous cycle disturbance. The estrous cycle is a perfectly synchronised and sequenced event that relies on a permanent endocrine dialogue between the ovary and the hypothalamo- pituitary system. Those pathways differentiate during fetal life and are largely influenced by numerous factors and in particular the steroid environment of the foetus. BPA at the adult stage alters the endocrine steroidogenic function of the ovary and more specifically the production of estrogens by the follicle, leading to disturbance in the estrous cycle. At the neuroendocrine level, BPA can also act during the perinatal/postnatal organisation or adult activation of the hypothalamus-pituitary system through changes in kisspeptin, gonadotrophin-releasing hormone (GnRH) expression, activity or liberation and sex steroid receptor expression that impact estrous cyclicity. The effects on the mammary gland, depending on the period of exposure, include: modifications in the mammary tissue such as an increased number of terminal end buds (TEBs) relative to the ductal area, fewer apoptotic TEB cells, increased lateral branching and ductal hyperplasia, increased cell proliferation and decreased apoptosis in the glandular epithelium, ductal (and occ...
Sample 1

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