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Diss Factsheets

Administrative data

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:
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.”

Chrome antimony titanium buff rutile 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 (Klawonn, 2017) that indicate a very low release of pigment components. Transformation/dissolution tests of chrome antimony titanium buff rutile for 24 h at a loading of 100 mg/L (24 h-screening test according to OECD Series 29) resulted in mean dissolved antimony concentrations of 1.859 and 2.139 µg Sb/L and dissolved chromium concentrations of 0.029 and 0.193 µg Cr/L at pH 6 and 8, respectively. According to ECHA Guidance on the Application of the CLP Criteria (Version 5.0, July 2017), “Where the acute ERV for the metal ions of concern is greater than 1 mg/L the metals need not be considered further in the classification scheme for acute hazard”. Further, “Where the chronic ERV for the metal ions of concern is greater than 1 mg/L, the metals need not be considered further in the classification scheme”. Accordingly, titanium was not considered in the T/D assessment since it does not have an ecotoxic potential as confirmed by ecotoxicity reference values of > 100 mg Ti/L listed in the Metals classification tool (MeClas) database. The release of antimony and chromium from chrome antimony titanium buff rutile in aqueous media is highest at pH 8 and thus pH 8 is considered as pH that maximises dissolution. Metal release at the 1 mg/L loading and pH 8 resulted in dissolved antimony and chromium concentrations of 0.766 µg Sb/L and 0.071 µg Cr/L after 7 days and 1.027 µg Sb/L and 0.050 µg Cr/L after 28 days, respectively. Thus, the rate and extent to which chrome antimony titanium buff rutile produces soluble (bio)available ionic and other antimony- or chromium-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 chrome antimony titanium buff rutile 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).”

The potential essentiality and bioaccumulation of the pigment components antimony, chromium and titanium can be summarized as follows:

An essential or beneficial effect of antimony is not known (Goyer et al, 2004). According to the EU Risk Assessment of diantimony trioxide (EU RAR, 2008), “The bioaccumulation potential seems to be low to moderate. No reliable bioaccumulation studies are available and measured data from different aquatic organisms have been used to calculate tentative BCF values. For marine fish the BCFs vary between 40 and 15000 whereas for freshwater fish the BCF values are lower, the highest being 14. For invertebrates tentative BCFs below 1 up to 4000-5000 have been calculated. It should be noted that there is a considerable uncertainty in these BCF values. The BCF value finally used in the risk characterisation is 40.” Hence, antimony is not expected to biomagnify.

According to the EU RAR on chromates (ECB, 2005) “uptake of chromium (III) directly from water is likely to be very low due to the limited water solubility and strong adsorption to sediment under most conditions found in the environment…Transfer of chromium via the alga -> bivalve, and sediment -> bivalve food chains appears to be relatively low.” A similar conclusion is reached by WHO (2009) in its assessment of inorganic chromium (III) compounds. “Chromium (III) is required by only some microorganisms for specific metabolic processes, such as glucose metabolism and enzyme stimulation. Chromium (III), in trace amounts, has been reported to be an essential component of animal nutrition and is most notably associated with glucose and fat metabolism (WHO, 2009).” For chromium as essential element, it is thus assumed that internal levels are homeostatically regulated and that it does not bioaccumulate and biomagnify in aquatic food-chains. Thus, the potential for bioaccumulation of chromium (III) in aquatic environments is low based on its poor solubility in environmental media.

Titanium has very low mobility under almost all environmental conditions, mainly due to the high stability of the insoluble oxide TiO2 under all, but the most acid conditions, i.e., below pH 2. There is no evidence to suggest that Ti performs any necessary role in the human body. Titanium is considered to be non-toxic, because of its poor absorption and retention in living organisms” (Salminen et al, 2005 and references therein). A similar conclusion was reached by WHO (1982) as follows: “There is no evidence of titanium being an essential element for man or animals”, and “…titanium is poorly absorbed and retained by both animals and plants…”. Thus, titanium is also not expected to bioaccumulate to any relevant extent or to biomagnify.

The OECD SIDS Initial Assessment (2002) of chrome antimony titanium buff rutile summarises: “No data on bioaccumulation are available. However, regarding the extremely low water solubility, experiences from rodent investigations and the structure-related inert properties of the rutile, bioavailability and therefore bioconcentration is not expected”. The OECD SIDS Initial Assessment (2002) concludes: “According to the low water solubility and the structural properties of the pigment, bioaccumulation is not expected.”.

Thus, based on the poor solubility of chrome antimony titanium buff rutile in aquatic environments, the potential of chrome antimony titanium buff rutile 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 chrome antimony titanium buff rutile in accordance with Column 2 of Information Requirement 9.3.2., Annex IX, Commission Regulation (EU) 1907/2006.


ECB (2005) European Union Risk Assessment Report: Chromium trioxide, sodium chromate, sodium dichromate, ammonium dichromate and potassium dichromate. EUR 21508 EN.

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

EU RAR (2008) Risk assessment - Diantimony trioxide, CAS No: 1309-64-4, EINECS No: 215-175-0. Final report, November 2008.

Goyer R et al (2004) Issue paper on the human health effects of metals. Submitted to U.S. Environmental Protection Agency, 19.08.2004.

OECD (2002) SIDS Initial Assessment Profile C.I. Pigment Brown 24, CAS No. 68186-90-3. SIAM 15, 22-25 October 2002.

Salminen et al. (2005) Geochemical Atlas of Europe - Part 1: Background information, Methodology and Maps. EuroGeoSurveys.

WHO (1982) Environmental Health Criteria 24 - Titanium. International Programme on Chemical Safety.

WHO (2009) Concise International Chemical Assessment Document 76 (CICAD). Inorganic chromium (III) compounds. International Programme of Chemical Safety (IPCS), WHO, Geneva.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion