Manganese alumina pink corundum

Toxicity to terrestrial arthropods

Administrative data

Endpoint:

toxicity to terrestrial arthropods: 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 9.4., Annex IX, Commission Regulation (EU) 1907/2006, ”These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. Where the equilibrium partitioning method is applied to nanoforms, this shall be scientifically justified. The choice of the appropriate tests depends on the outcome of the chemical safety assessment. In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term.”

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.”

Manganese alumina pink corundum 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 at pH 6, the pH that maximises dissolution. At a loading of 1 mg/L and pH 6, dissolved concentrations of 0.29 and 0.042 µg/L aluminium and 10.66 and 8.91 µg/L manganese were measured after 7 and 28 days, respectively. Thus, the rate and extent to which Manganese alumina pink corundum produces soluble (bio)available ionic and other aluminium- and manganese-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 Manganese alumina pink corundum is expected to determine its behaviour and fate in the environment, and subsequently its potential for ecotoxicity.

Proprietary studies are not available for Manganese alumina pink corundum. The poorly soluble substance Manganese alumina pink corundum 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. The ERVs are based on the lowest EC50/LC50 and NOEC/EC10 values for algae, invertebrates and fish. Acute and chronic ERVs were obtained from the Metals classification tool (MeClas) database as follows: For aluminium, acute ERVs of 1,040 µg Al/L at pH 6 and 3,390 µg Al/L at pH 8 were derived, and a concern for long-term (chronic) toxicity of aluminium ions was not identified (no classification).

The acute and chronic ERVs of manganese are 3,200 and 550 µg Mn/L, respectively. The determined dissolved aluminium and manganese concentrations of 0.29 µg Al/L and 10.66 µg Mn/L in the T/D test after 7 days at pH 6 are significantly lower than the corresponding lowest short-term ERVs (1,040 µg Al/L at pH 6 and 3,200 µg Mn/L). Thus, the substance Manganese alumina pink corundum is not sufficiently soluble to cause short-term toxicity at the level of the acute ERVs (expressed as EC50/LC50). Due to the lack of a long-term aquatic hazard potential for soluble aluminium ions, only manganese concentrations and the corresponding chronic ERV is taken into account. The dissolved manganese concentrations of 8.91 µg Mn/L at a loading of 1 mg/L after 28 days at pH 6 is significantly lower than the lowest long-term ERV of 550 µg Mn/L. Thus, the substance Manganese alumina pink corundum is not sufficiently soluble to cause short-term or long-term toxicity at the level of the acute or chronic ERVs (expressed as EC50/LC50 or NOEC/EC10, respectively).

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 Manganese alumina pink corundum is poorly soluble and does not meet classification criteria for acute (short-term) and chronic (long-term) aquatic hazard.

Manganese alumina pink corundum 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 soil compartment because toxicity to aquatic organisms is used as an indicator of concern for soil organisms and a screening risk characterisation (using the equilibration partitioning method to derive a PNEC for soil) cannot be undertaken. Thus, Manganese alumina pink corundum does not have a “non-classified hazard” potential.

With an average crustal abundance of about 8.3%, aluminium is the most abundant metal in the lithosphere and ubiquitous in the environment. As ubiquitous element, it is a major constituent of many rock-forming minerals, and the weathered products of aluminium minerals include secondary clay minerals, and aluminium-hydroxides, which may control the equilibrium concentration of aluminium in soil solution, groundwater and stream water. The speciation of aluminium in the environment is determined by pH, mineralogical composition, and the abundance of organic complexing agents. Under most environmental conditions, aluminium has a low mobility. However, decreasing pH (below pH 5.5) increases the mobility of aluminium ions (Salminen et al. 2005 and references therein).


Monitoring data for elemental aluminium and manganese background concentrations in soil are provided by the FOREGS Geochemical Baseline Mapping Programme, that offers high quality, multi-purpose homogeneous environmental geochemical baseline data for Europe (Salminen et al. 2005).
The FOREGS dataset for EU-27 countries plus UK and Norway reports aluminium oxide concentrations for 833 topsoil samples. Baseline aluminium levels in topsoil range from 1,958.2 to 141,151.2 mg Al/kg with 5th, 50th and 95th percentiles of 16,322.1, 58,376.4 and 92,121.4 mg Al/kg, respectively.

Additionally, aluminium and manganese concentrations of agricultural soils were determined in the GEMAS project (Geochemical Mapping of Agricultural and Grazing land Soil), that offers high quality harmonized, freely and interoperable geochemical data for the top layer of agricultural and grazing land soil (Reimann et al. 2014). For the EU-27, UK and Norway, 1,867 and 1,781 samples of agricultural and grazing land soil were analysed for aluminum and manganese.

Aluminum levels of agricultural soil range from 351.6 to 64,527.0 mg Al/kg with 5th, 50th and 95th percentiles of 2,508.0, 10,769.4 and 23,999.1 mg Al/kg, respectively. In grazing land, soil concentrations of aluminum range from 627.3 to 62,541.8 mg Al/kg with 5th, 50th and 95th percentiles of 2,335.6, 10,506.8 and 25,326.4 mg Al/kg, respectively.

Based on the FOREGS dataset, the 95th percentile of 92,121.4 mg Al/kg can be regarded as representative background concentration of aluminum in topsoil of EU countries. Representative aluminum concentrations (95th percentile) of agricultural and grazing land soil (i.e. ambient levels) amount to 23,999.1 and 25,326.4 mg Al/kg, respectively, according to the GEMAS dataset.

Manganese is a ubiquitous lithophile element with an average abundance of 600 mg Mn/kg in the upper crust. Manganese occurs in several rock-forming minerals (Salminen et al. 2005). As essential trace elements, manganese acts as catalytic or structural components of larger molecules, which occupy key roles in essential metabolic pathways of microorganisms, plants, and animals. Hence, manganese as essential nutrient is actively assimilated and utilized by plants and animals (WHO 2004 and references therein).

According to the FOREGS dataset, baseline manganese levels in topsoil range from < 10.0 to 6,483.0 mg Mn/kg with 5th, 50th and 95th percentiles of 52.2, 382.0 and 1,435.0 mg Mn/kg, respectively. Manganese levels of agricultural soil range from 1.6 to 14,968.7 mg Mn/kg with 5th, 50th and 95th percentiles of 71.2, 428.6 and 1,411.2 mg Mn/kg, respectively. In grazing land, soil concentrations of manganese range from 6.9 to 4,413.7 mg Mn/kg with 5th, 50th and 95th percentiles of 74.2, 423.0 and 1,386.4 mg Mn/kg, respectively.

Based on the FOREGS dataset, the 95th percentile of 1,435.0 mg Mn/kg can be regarded as representative background concentration of manganese in topsoil of EU countries. Representative manganese concentrations (95th percentile) of agricultural and grazing land soil (i.e. ambient levels) amount to 1,411.2 and 1,386.4 mg Mn/kg, respectively, according to the GEMAS dataset.

Aluminium (hydr)oxides and manganese minerals including (hydr)oxides are common and ubiquitous constituents of soil, and soil organisms are adapted to their presence. The addition of anthropogenic aluminium and manganese in a poorly soluble form to soil is not expected to be relevant for respective total and bioavailable soil concentrations and toxicity. Thus, additional soil testing is not expected to provide any further insight.

Manganese alumina pink corundum is not classified as harmful, toxic or very toxic to aquatic life or may cause long lasting harmful effects to aquatic life. Manganese alumina pink corundum 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 of manganese and aluminium in soil, Manganese alumina pink corundum is also not considered an unclassified hazard to the soil compartment. Results of the chemical safety assessment do not indicate the need to investigate further the effects of Manganese alumina pink corundum on soil organisms. Therefore, the study on short-term toxicity to soil invertebrates does not need to be conducted in accordance with Column 2 of Information Requirement 9.4.1., Annex IX, Commission Regulation (EU) 1907/2006.

References:

Reimann et al. (2014) Chemistry of Europe’s agricultural soils - Part A: Methodology and interpretation of the GEMAS data set.

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

WHO (2004) Concise International Chemical Assessment Document 63 - Manganese and its compounds: Environmental aspects