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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
bioaccumulation in aquatic species: fish
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
The full list of bibliographical references cited in the justification for data waiving is provided in the Endpoint Summary of Section 5.3.1. When appropriate, Endpoint Study Records were created in the relevant IUCLID sections to reflect these bibliographical data (see the field "Cross-references" below).
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Description of key information

Although iron oxide isostearate is not expected to give rise to high dissolved concentrations available for uptake by living organisms (see IUCLID section 4.8), existing data were nevertheless considered to conclude on the aquatic bioaccumulation potential by looking at both the organic and the inorganic parts of this substance:

 

For the inorganic iron part, ECHA disseminated portal was used as a starting point to collect information (e.g. disseminated dossiers on iron, CAS 7439-89-6, and on iron dichloride, CAS 7758-94-3). Iron is described as an essential trace element, which is well regulated in all living organisms: indeed, iron plays an important role in biological processes, and iron homeostasis is under strict control (e.g. for aquatic organisms: Golterman 1975, Morel et al. 2003, Chanda et al. 2016, Wang & Wang 2016). The available evidence shows the absence of iron biomagnification across the trophic chains (e.g. for aquatic compartment: Wren et al. 1983, disseminated dossiers of iron and iron dichloride). The fact that no risk is expected from iron’s bioaccumulation / biomagnification properties is well illustrated in the UK Environmental Agency’s Science Report which aimed to propose EQS (Environmental Quality Standards) in the context of the Water Framework Directive. Indeed, in this report, no PNEC (i.e. to be adopted as EQS) was proposed for secondary poisoning: “Iron is an essential element that has been shown not to bioaccumulate in higher organisms. This is because absorption of iron depends on an organism’s requirements for iron and this is regulated so that excessive amounts of iron are not stored in the body. It is, therefore, considered unnecessary to derive a PNEC addressing secondary poisoning of predators” (Johnson et al. 2007).

 

For the organic isostearate part, ECHA disseminated portal was also used as a starting point to collect information (disseminated dossier on isostearic acid, CAS 30399-84-9). It can be found that dimerised fatty acids are considered to pose no risk to aquatic organisms from their bioconcentration and biomagnification properties. This is argued on the following basis:

• Extremely low exposure of the aquatic environment expected from the poor water solubility and the ready biodegradation potential in particular in the case of isostearic acid (CIR 1983, disseminated dossier on isostearic acid).

• Natural occurrence in all aquatic organisms as a nutritional energy source, as lipids in adipose tissue, as precursors for signaling molecules and as an integral part of the cell membranes of every living organism (Institute of Medecine 2005, De Carvalho & Caramujo 2018). In addition, fatty acids are known to be easily metabolized and excreted (CIR 1983, 1987, Institute of Medecine 2005, Kornberg 2019). Furthermore, as fatty acids are the end products of carbohydrate metabolism in living organisms muscle tissues, an evaluation of anthropogenic distribution of fatty acids based on the concentrations determined in the organs and tissues of aquatic organisms may be overestimated, if not completely irrelevant (disseminated dossier on isostearic acid).

 

As already indicated, iron oxide isostearate is not expected to give rise to high dissolved concentrations available for uptake by living organisms (see IUCLID section 4.8) and in case of any dissolution, this substance can be considered from the above pool of evidence as posing no risk to aquatic organisms from its bioconcentration and biomagnification properties.

Key value for chemical safety assessment

Additional information

References:

- Chanda et al. (2016). Dietary essentiality of trace minerals in aquaculture: A Review. Agricultural Review 36 (2): 100-112.

- CIR (1983). Final report on the safety assessment of isostearic acid. Journal of the American College of Toxicology 2 (7): 61-401.

- CIR (1987). Final report on the safety assessment of oleic acid, lauric acid, palmitic acid, myristic acid, stearic acid. Journal of the American College of Toxicology 6 (3): 321-401.

- De Carvalho & Caramujo (2018). The Various Roles of Fatty Acids. Molecules 23: 2583.

- Golterman (1975). Chapter 11 Trace Elements. Part of volume: Physiological Limnology: An Approach to the Physiology of Lake Ecosystems (edited by H.L. Golterman). Developments in Water Science 2: 199-214.

- Institute of Medicine (2005). Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Chapter 8 - Dietary Fats: Total Fat and Fatty Acids. Washington, DC: The National Academies Press.

- Johnson et al. (2007). Proposed EQS for Water Framework Directive Annex VIII substances: iron (total dissolved). UK Environmental Agency Science Report: SC040038/SR9. SNIFFER Report: WFD52(ix).

- Kornberg (2019). Metabolism. The fragmentation of complex molecules. The catabolism of lipids (fat). Fate of fatty acids. Encyclopædia Britannica.

- Morel et al. (2003). Marine Bioinorganic Chemistry: The Role of Trace Metals in the Oceanic Cycles of Major Nutrients. Treatise on Geochemistry 6: 113-143.

- Wang & Wang (2016). Novel insights into iron regulation and requirement in marine medakaOryzias melastigma. Scientific Reports 6: 26615.

- Wren at al. (1983). Examination of bioaccumulation and biomagnification of metals in a Precambrian Shield lake. Water Air and Soil Pollution 19(3): 277-291.