Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance has a low potential to cross biological membranes
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Column 2 of Information Requirement 9.3.2., Annex IX, Commission Regulation (EU) 1907/2006, ”The study need not be conducted if: the substance has a low potential for bioaccumulation (for instance a log Kow ≤ 3) and/or a low potential to cross biological membranes.”

High-temperature calcination products of diiron trioxide and amorphous silica resulting in a glassy silica matrix can be considered environmentally and biologically inert due to the characteristics of the synthetic process (calcination at a high temperature of approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which all atoms are tightly bound and not prone to dissolution in environmental and physiological media. This assumption is supported by available transformation/dissolution data (Grané, 2010) that indicate a very low release of pigment components. Transformation/dissolution of High-temperature calcination products of diiron trioxide and amorphous silica resulting in a glassy silica matrix (24-screening test according to OECD Series 29, loading of 100 mg/L, pH 6 and 8) resulted in mean dissolved iron concentrations of 0.131 µg/L Fe and 0.002 µg/L Fe, silicon concentrations of 215.7 µg/L Si and 204 µg/L Si at pH 6 and 8, respectively. Dissolution of iron and silicon is highest at pH 6, therefore pH 6 is considered as pH that maximised metal release. Metal release at the 1 mg/L loading and pH 6 remained below the respective LOD for iron and silicon (<0.22 µg/L Fe and <0.07 µg/L Si). After 28 days at the 1 mg/L loading and pH 6 iron concentrations of 0.29 µg/L were measured whereas silicon concentrations remained below the LOD (< 0.07 µg/L Si). Thus, the rate and extent to which High-temperature calcination products of diiron trioxide and amorphous silica resulting in a glassy silica matrix produces soluble (bio)available ionic and other silicon- and iron-bearing species in environmental media is limited. Hence, the pigment can be considered as environmentally and biologically inert during short- and long-term exposure. The poor solubility of High-temperature calcination products of diiron trioxide and amorphous silica resulting in a glassy silica matrix is expected to determine its behaviour and fate in the environment, including its low potential for bioaccumulation.

Further, “for naturally occurring substances such as metals, bioaccumulation is more complex, and many processes are available to modulate both accumulation and potential toxic impact. Many biota for example, tend to regulate internal concentrations of metals through (1) active regulation, (2) storage, or (3) a combination of active regulation and storage over a wide range of environmental exposure conditions. Although these homeostatic control mechanisms have evolved largely for essential metals, it should be noted that non-essential metals are also often regulated to varying degrees because the mechanisms for regulating essential metals are not entirely metal-specific (ECHA, 2008).”

Regarding the potential of bioaccumulation the OECD (2004) states, “the bioavailable forms of silica (SiO2) are dissolved silica [Si(OH)4] almost all of which is of natural origin. The ocean contains a huge sink of silica and silicates where a variety of the marine habitat (diatoms, radiolarians, and sponges) is able to exploit this resource as a construction material to build up their skeletons”. Most organisms contain silicon at least at trace levels. Whereas silicon is essential for some organisms, including diatom algae, gastropods and mammals, and actively taken up, others take it up passively and excrete it.

“Due to the known inherent physico-chemical properties, absence of acute toxic effects as well as the ubiquitous presence of silica/silicates in the environment, there is no evidence of harmful long-term effects arising from exposure to synthetic amorphous silica/silicates (OECD, 2004).” Thus, given the ubiquitous presence of silica and silicates in the environment, silicon is regarded as element without or with a very low potential for bioconcentration and bioaccumulation.

Iron as essential element plays a crucial role in a wide variety of biological process, i.e. electron transport, nitrogen fixation and oxidative metabolism. As an essential component of haemoglobin, it functions as a carrier of oxygen in the blood and muscles of animals. The uptake of iron into cells is actively regulated by a strict homeostatic control system. The active regulation of iron uptake in combination with internal detoxification mechanism indicates a low potential for iron bioaccumulation. This assumption is supported by results of Bustamante et al. (2000) indicating that iron concentrations of digestive glands of cephalopods living in natural and in iron-enriched habitats are similar. Winterbourn et al. (2000) further demonstrate that iron does not biomagnify but rather “biodilutes” up the aquatic food chain. Thus, the potential for bioaccumulation in aquatic environments can be expected to be low.

Thus, based on the poor solubility of High-temperature calcination products of diiron trioxide and amorphous silica resulting in a glassy silica matrix in aquatic environments and essentiality and active regulation of internal concentrations of silicon and iron, the potential of High-temperature calcination products of diiron trioxide and amorphous silica resulting in a glassy silica matrix for bioaccumulation can safely be expected to be low. Consequently, the study on bioaccumulation does not need to be conducted based on low solubility, bioavailability and a corresponding low bioaccumulation potential of High-temperature calcination products of diiron trioxide and amorphous silica resulting in a glassy silica matrix in accordance with Column 2 of Information Requirement 9.3.2., Annex IX, Commission Regulation (EU) 1907/2006.

References:

Bustamante et al. (2000) Bioaccumulation of 12 trace elements in the tissues of the nautilus Nautilus macromphalus from New Caledonia. Marine Pollution Bulletin 40/8: 688-696.

ECHA (2008) Guidance on IR & CSA, Appendix R.7.13-2: Environmental risk assessment for metals and metal compounds. July 2008.

OECD (2004) SIDS Initial Assessment Profile Silicon dioxide, Silicic acid, aluminum sodium salt, Silicic acid, calcium salt. SIAM 19, 19-22 October 2004.

Winterbourn et al. (2000) Aluminium and iron burdens of aquatic biota in New Zealand streams contaminated by acid mine drainage: effects of trophic level. The Science of The Total Environment 254, 45-54.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion