Bioaccumulation Sample Clauses

Bioaccumulation. The numeric criterion as suggested in REACH Annex XIII for a bioaccumulative substance is not fulfilled for PFOA. Due to its notable water solubility, PFOA might quickly be excreted via ▇▇▇▇ permeation. Furthermore, PFOA occurs mainly in protein rich tissues like blood and liver (OECD, 2006; ▇▇▇▇▇ et al. 2009). Hence, bioconcentration in ▇▇▇▇ breathing organisms and the accumulation in lipids may not be the most relevant endpoint to consider. Field studies show, that air-breathing organisms are more likely to biomagnify PFOA compared to water breathing organisms. Therefore, the numerical bioaccumulation (B) criterion defined in the REACH regulation Annex XIII (sections 1.1.2 and 3.2.2(a)) is not suitable for PFOA to assess its bioaccumulation potential. Annex XIII (section 3.2.2) defines information which should be taken into account when the numerical criterion is not applicable, for example data on the bioaccumulation potential in terrestrial species or in endangered species (Annex XIII, 3.2.2 (b)). PFOA was found in terrestrial species as well as in endangered species as shown for the polar bear and in animals which are likely to become endangered in the near future (narwhale and beluga whale). These findings are of high concern and indicate a bioaccumulation potential. Furthermore Annex XIII (section 3.2.2 (b)) allows taking data from human body fluids or tissues and the toxicokinetic behavior of a substance into account. For PFOA a gestational and lactational exposure in humans was shown, which are of special concern as the foetus and newborn babies are highly vulnerable to exposure to toxic substances. On top of that data from human body fluids clearly provide quantitative proof of the bioaccumulation of PFOA: Half-lives in humans are around 2-4 years. In addition, recent studies, taking into account relevant confounding factors, show that PFOA blood concentrations in humans increase with increasing age. Finally ▇▇▇▇▇ ▇▇▇▇ (section 3.2.2 (c)) foresees that the ability for biomagnifications in food chains of a substance is assessed. For PFOA field studies provide trophic magnification factors (TMFs) or biomagnification factors (BMFs) for PFOA for aquatic and terrestrial food chains. When air breathing organisms are top predators in these food chains biomagnification was quantitatively demonstrated by TMFs and BMFs > 1 for several food chains, for example TMFs 1.1 – 2.4 in the food chain on wolfs 6.3 – 13 in the food chain of dolphins and 1.4 – 2.6 (pr...

Bioaccumulation. Results from bioconcentration and bioaccumulation studies in aquatic species: Other information on the bioaccumulation potential and ability of the substance to biomagnify in the food chain: Conclusion on the bioaccumulation potential:

Bioaccumulation. Based on a direct comparison with the bioaccumulation criteria for aquatic organisms, PFHpA and its salts do not seem to be bioaccumulative in water-breathing organisms. In air-breathing organisms results appear to differ between species. In rats, the elimination half-life for both males and females is less than 1 day. In pigs, however, much longer elimination half-lives have been reported with the highest values being in the order of 500 days. There was considerable variation between individual pigs though, resulting in a geometric mean elimination half-life of 74 days. The latter value corresponds to a biomagnification factor of 2.7, showing that PFHpA and its salts have the potential to biomagnify in pigs. Therefore, PFHpA and its salts should be considered very bioaccumulative (vB) in at least some air-breathing species such as the pig. The elimination half-life of PFHpA of 74 days fits well between values derived for PFOA (236 days) and PFHxA (4.1 days) that are the closest structural analogues differing only by one perfluorinated carbon in chain length. Several studies in humans point to high elimination half-lives with the highest value being

Bioaccumulation. The accumulation of contaminants in the tissue of organisms through any route, including respiration, ingestion, or direct contact with contaminated water, sediment, or pore water. Bioassay: A bioassay is a test using a biological system. It involves exposing an organism to a test material and determining a response. There are two major types of bioassays differentiated by response: toxicity tests which measure an effect (e.g. acute toxicity, sublethal/chronic toxicity) and bioaccumulation tests which measure a phenomenon (e.g. the uptake of contaminants into tissues). Contaminant of Concern (COC): A contaminant present in a given sediment thought to have the potential for unacceptable adverse environmental impact due to a proposed discharge. A contaminant is defined as a chemical substance in a form that can be toxic to or bioaccumulate in aquatic organisms, consumers of aquatic organisms, or users of the aquatic environment, and includes but is not limited to the substances listed on the 307(a)(1) list of toxic pollutants promulgated on January 31, 1978 (43 FR 4109). Data Quality Objectives (DQO): Qualitative and quantitative statements that clarify study objectives, define appropriate types of data and specify tolerable levels of potential decision errors that will be used as the basis for establishing the quality and quantity of data needed to support decisions. DQOs provide the framework for planning environmental data operations consistent with the data user’s needs. Dissolved Fraction or Liquid Phase: The dissolved fraction of the elutriate process is that portion of the elutriate supernatant that has been filtered through a 0.45 Φm filter (or centrifuged and then filtered).

Bioaccumulation. Due to its expected notable water solubility, PFDA is, like the other PFCAs, expected to be quickly excreted in fish via ▇▇▇▇ permeation. Hence, bioconcentration in ▇▇▇▇-breathing organisms is not the most relevant endpoint to consider, as reflected by the differences between bioaccumulation data for ▇▇▇▇- and air-breathing organisms. Field studies show that air-breathing organisms are more likely to bioaccumulate PFDA and other PFCAs compared to ▇▇▇▇-breathing organisms. Based on the BCF values for PFDA it cannot be excluded that PFDA is bioaccumulative in fish: BCF values range from 450 to 2700 for carcass, liver and blood. Conclusions on bioaccumulation should be based on whole body values and carcass is seen as a good approximation for whole body. Based on the BCF of carcass PFDA does not bioaccumulate in fish. However, PFDA does not accumulate in lipid but rather binds to protein and membrane phospholipids, therefore the carcass or whole-body BCF values are less relevant. Based on the BCF value in the blood of rainbow trout (2700±350), PFDA can be considered bioaccumulative. REACH Annex XIII (section 3.2.2) defines information which shall be taken into account in the assessment and can be used to draw conclusions on the assessment even when the numerical criterion is not applicable. Such data are, for example, data on the bioaccumulation potential in terrestrial species, such as elevated levels in endangered species. PFDA has been found in terrestrial species as well as in endangered species e.g. the polar bear and the beluga whale. These findings indicate a bioaccumulation potential. Furthermore, REACH Annex XIII (section 3.2.2 (b)) requires to consider data from human body fluids or tissues and to take the toxicokinetic behaviour of the substance assessed into account. For PFDA, gestational and lactational exposure in humans has been shown, which is of special concern as the foetus and newborn babies are highly vulnerable to exposure by xenobiotic substances. On top of that, data from human body fluids clearly provide quantitative proof of the bioaccumulation of PFDA; elimination half-lives in humans are ≥ 4 years. In addition, recent studies, taking into account relevant confounding factors, show that PFDA blood concentrations in humans increase with increasing age. Finally, REACH Annex XIII (section 3.2.2 (c)) foresees that the potential for biomagnification in food chains of a substance is assessed. The available field data provide evidence that ...

Bioaccumulation. Regarding the bioaccumulation potential for C12-PFCA the available experimental BCF-values of C12-PFCA are above 5000. A number of field-BMFs and TMFs are available for C12-PFCA and they provide evidence that biomagnification of this substance takes place in nature between different trophic levels of food chains and from the bottom to the top of food chains (See Table 15 of the support document). Due to the structural similarity and the regular pattern of physico- chemical properties within the group of C11-14-PFCAs, read across can be applied within the group. The available field bioaccumulation data of C12-PFCA and the other substances of the group provide further support to assume that C12-PFCA biomagnifies in the food chain. Thus, it is concluded the B as well as the vB- criteria -are met in accordance with the criteria and provisions set out in Annex XIII of REACH.

Bioaccumulation. The accumulation of contaminants in the tissue of organisms through any route, including respiration, ingestion, or direct contact with contaminated water, sediment, or pore water. A bioassay is a test using a biological system. It involves exposing an organism to a test material and determining a response. There are two major types of bioassays differentiated by response: toxicity tests which measure an effect (e.g. acute toxicity, sublethal/chronic toxicity) and bioaccumulation tests which measure a phenomenon (e.g. the uptake of contaminants into tissues). A contaminant present in a given sediment thought to have the potential for unacceptable adverse environmental impact due to a proposed discharge. A contaminant is defined as a chemical substance in a form that can be toxic to or bioaccumulate in aquatic organisms, consumers of aquatic organisms, or users of the aquatic environment, and includes but is not limited to the substances listed on the 307(a)(1) list of toxic pollutants promulgated on January 31, 1978 (43 FR 4109). Qualitative and quantitative statements that clarify study objectives, define appropriate types of data and specify tolerable levels of potential decision errors that will be used as the basis for establishing the quality and quantity of data needed to support decisions. DQOs provide the framework for planning environmental data operations consistent with the data user’s needs. The dissolved fraction of the elutriate process is that portion of the elutriate supernatant that has been filtered through a 0.45 Φm filter (or centrifuged and then filtered).

Bioaccumulation. Regarding the bioaccumulation potential for C13-PFCA there are no available experimental BCF-values. The BCFs of C12-PFCA and C14-PFCA from fish flow- through bioaccumulation tests are well above 5000 (see Table 14 of the support document). Due to the structural similarity and the regular pattern of physic- chemical properties within this group it can be with a high reliability assumed that also C13-PFCA has a BCF larger than 5000, too. A number of field-BMFs and TMFs are available for C13-PFCA and they provide evidence that biomagnification of this substance takes place in nature between different trophic levels of food chains and from the bottom to the top of food chains (See Table 14 of the support document). Therefore, based on the information summarized above, it is concluded that C13-PFCA fulfils the B and the vB-criteria in Annex XIII of REACH.

Bioaccumulation. Next to very persistent musk xylene is also considered to be very bioaccumulative based on the results of the critical BCF-study in fish. Musk xylene can therefore be considered to be a vPvB substance. Musk xylene fulfils the vP and the vB criteria.