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Diss Factsheets

Administrative data

Endpoint:
sediment toxicity: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Column 2 of Information Requirement 9.5.1, Annex X, Commission Regulation (EU) 1907/2006 ” Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on sediment organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.”

According to Section 8.4.2 of ECHA Guidance on IR & CSA, Part B: Hazard assessment (Version 2.1; ECHA, 2011), “For substances which are classified as harmful, toxic or very toxic to aquatic life (i.e. H412, H411, H410 and H400), an aquatic PNEC can be derived. In these circumstances there are unclassified hazards to the sediment and soil compartments because toxicity to aquatic organisms is used as an indicator of concern for sediment and soil organisms, and a screening risk characterisation is undertaken using the equilibration partitioning method (EPM) to derive PNECs for sediment and soil. Hence quantitative exposure assessment, i.e. derivation of PECs, is mandatory for the water, sediment and soil environmental compartments.

Substances with the only environmental classification as ‘May cause long lasting harmful effects to aquatic life’ (i.e. H413) have been established as persistent in the aquatic environment and potentially bioaccumulative on the basis of test or other data. There are also potential hazards for these substances for the sediment and soil compartments, because these substances are potentially bioaccumulative in all organisms and are also potentially persistent in sediment and soil. Hence exposure assessment is mandatory for the water, sediment and soil environmental compartments, which may be quantitative or qualitative as appropriate. PBT and vPvB substances have been established as persistent and bioaccumulative (and the former also as toxic) in the environment as a whole. Hence qualitative exposure assessment is mandatory for the water, sediment and soil environmental compartments…

If there are ecotoxicity data showing effects in aquatic organisms, but the substance is not classified as dangerous for the aquatic environment, an aquatic PNEC can nevertheless be derived thus indicating a hazard to the aquatic environment. In these circumstances there are also unclassified hazards to the sediment and soil compartments because toxicity to aquatic organisms is used as an indicator of concern for sediment and soil organisms and a screening risk characterisation is undertaken using the equilibration partitioning method (EPM) to derive PNECs for sediment and soil. Hence quantitative exposure assessment, i.e. derivation of PECs, is mandatory for the water, sediment and soil environmental compartments.”

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, and subsequently its potential for ecotoxicity.

Proprietary studies investigating toxicity to sediment organisms are not available for chrome antimony titanium buff rutile. The poorly soluble substance chrome antimony titanium buff rutile is evaluated by comparing the dissolved metal ion levels resulting from the transformation/dissolution test after 7 and 28 days at a loading rate of 1 mg/L with the lowest acute and chronic ecotoxicity reference values (ERVs) as determined for the (soluble) metal ions. Acute and chronic ERVs are based on the lowest EC50/LC50 and NOEC/EC10 values for algae, invertebrates and fish, respectively. The ERVs were obtained from the Metals classification tool (MeClas) database as follows: The acute ERVs of antimony (12.1 mg Sb/L, ECHA disseminated database), trivalent chromium (> 100 mg Cr/L) and titanium (> 100 mg Ti/L) ions are above 1 mg/L and thus a concern for short-term (acute) toxicity was not identified (no classification). 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.” Furthermore, the metal release in the T/D test at 1 mg/L loading and pH 8, the pH that maximises dissolution, resulted in dissolved antimony and chromium concentrations of 0.766 µg Sb/L and 0.071 µg Cr/L after 7 days, respectively. Due to the metal release in the 7 days T/D test at 1 mg/L loading and the lack of an aquatic hazard potential for antimony, chromium and titanium ions, it can be concluded that the substance chrome antimony titanium buff rutile is not sufficiently soluble to cause short-term toxicity at the level of the acute ERVs (expressed as EC50/LC50).
Regarding the long-term toxicity, the chronic ERVs of antimony (1.130 mg Sb/L), trivalent chromium and titanium (> 100 mg Ti/L) ions are above 1 mg/L, and a concern for long-term (chronic) toxicity was not identified (no classification). According to ECHA Guidance on the Application of the CLP Criteria (Version 5.0, July 2017), ”Where the chronic ERV for the metal ions of concern corrected for the molecular weight of the compound (further called as chronic ERV compound) is greater than 1 mg/L, the metal compounds need not to be considered further in the classification scheme for long-term hazard.” Furthermore, the metal release in the T/D test at 1 mg/L loading and pH 8, the pH that maximises dissolution, resulted in dissolved antimony and chromium concentrations of 1.027 µg Sb/L and 0.050 µg Cr/L after 28 days, respectively. Due to the metal release in the 28 days T/D test at 1 mg/L loading and the lack of an aquatic hazard potential for antimony, chromium and titanium ions, it can be concluded that the substance chrome antimony titanium buff rutile is not sufficiently soluble to cause long-term toxicity at the level of the chronic ERVs (expressed as NOEC/EC10).

In accordance with Figure IV.4 “Classification strategy for determining acute aquatic hazard for metal compounds” and Figure IV.5 „Classification strategy for determining long-term aquatic hazard for metal compounds “of ECHA Guidance on the Application of the CLP Criteria (Version 5.0, July 2017) and section 4.1.2.10.2. of Regulation (EC) No 1272/2008, the substance chrome antimony titanium buff rutile is poorly soluble and does not meet classification criteria for acute (short-term) and chronic (long-term) aquatic hazard.

Chrome antimony titanium buff rutile is not classified as dangerous for the aquatic environment, an aquatic PNEC cannot be derived, thus not indicating a hazard to the aquatic environment. In these circumstances there are also not unclassified hazards to the sediment compartment because toxicity to aquatic organisms is used as an indicator of concern for sediment organisms and a screening risk characterisation (using the equilibrium partitioning method to derive a PNEC for sediment) cannot be undertaken. Thus, chrome antimony titanium buff rutile does not have a “non-classified hazard” potential.

In stream sediment, antimony ions are present primarily in detrital sulphide minerals, e.g., stibnite, sphalerite and galena, some of which may weather relatively rapidly under acid, oxidising conditions. Further remobilisation of antimony is rather limited due to the tendency of antimony ion to form insoluble basic salts and be adsorbed by secondary hydrous Fe, Al and Mn oxides at pH levels in the range 4.0 - 8.0 (Salminen et al. 2005 and references therein).

Chromium is naturally abundant in sediments and a significant fraction of the total chromium is associated with the solid phase (e.g., bound to particulate phase, precipitation of insoluble inorganic complexes). In sediment, trivalent chromium will be converted rapidly to insoluble Cr(III)-species and therefore has a low mobility in this compartment (Salminen et al. 2005 and references therein).

Titanium exists only in a fully hydrated form, TiO(OH)2, in water above pH 2, and is therefore transported in a colloidal state rather than as a dissolved ion. A large proportion of titanium in stream sediments is held in minerals, such as rutile, ilmenite and sphene, all of which are relatively insoluble (Salminen et al. 2005 and references therein).

Monitoring data for antimony, chromium and titanium background concentrations in stream water sediments are provided by the FOREGS Geochemical Baseline Mapping Programme, which offers high quality, multi-purpose homogeneous environmental geochemical baseline data for Europe.

A total of 735 (Sb), 734 (Cr) and 739 (Ti) stream sediment samples were processed in the FOREGS-program for the EU-27, UK and Norway to determine representative concentrations. In stream sediments, antimony concentrations range from < 0.02 (< LOQ) to 34.1 mg Sb/kg with 5th, 50th and 95th percentiles of 0.2, 0.6 and 2.9 mg Sb/kg, respectively. Chromium sediment concentrations range from 2.0 to 1,748.0 mg Cr/kg with 5th, 50th and 95th percentiles of 6.0, 21.0 and 63.0 mg Cr/kg and titanium concentrations range from 95.9 to 29,919.2 mg Ti/kg with 5th, 50th and 95th percentiles of 1,354.5, 3,871.8 and 8,067.2 mg Ti/kg, respectively.

Taking into account the high quality and representativeness of the FOREGS data set, the 95th percentiles of 2.9 mg Sb/kg, 63.0 mg Cr/kg, and 8,067.2 mg Ti/kg sediment can be considered as representative background concentration of antimony, chromium and titanium in European stream sediments.

Regarding the essentiality of pigment components, antimony and titanium are non-essential elements without a known biological function in living organisms (Goyer et al, 2004; Salminen et al. 2005 and references therein; WHO, 1982). “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).”

Antimony, chromium and titanium are abundant in sediments and sediment organisms are well adapted to it. The addition of anthropogenic antimony, chromium and titanium in a poorly soluble form to aquatic environments and sediments is not expected to be relevant for respective total and bioavailable sediment concentrations and toxicity. Thus, additional sediment testing is not expected to provide any further insights. Considering abundance in the sediment, the potential of antimony, chromium and titanium ions for toxicity to sediment organisms can be expected to be low.

Chrome antimony titanium buff rutile is not classified as harmful, toxic or very toxic to aquatic life or may cause long lasting harmful effects to aquatic life. Chrome antimony titanium buff rutile is also not an unclassified hazard to the aquatic environment. Based on the poor solubility, bioavailability, lack of a potential for bioaccumulation and toxicity to aquatic organisms and considering ubiquitousness and bioavailability of antimony, chromium and titanium in sediment as well as essentiality and low bioaccumulation of antimony, chromium and titanium, chrome antimony titanium buff rutile is also not considered an unclassified hazard to the sediment compartment. Results of the chemical safety assessment do not indicate the need to investigate further the effects of chrome antimony titanium buff rutile on sediment organisms. Therefore, studies on the long-term toxicity to sediment organisms do not need to be conducted in accordance with Column 2 of Information Requirement 9.5.1., Annex X, Commission Regulation (EU) 1907/2006.

References:

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

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.
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion