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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
the study does not need to be conducted because the substance is unlikely to cross biological membranes, hence indicating that aquatic toxicity is unlikely to occur
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Annex VII, Column 2, Section 9.1.1. of Regulation (EC) 1907/2006, testing for short-term toxicity on invertebrates does not need to be conducted if “there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes”.

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 days at a loading rate of 1 mg/L with the lowest acute ecotoxicity reference values (ERVs) as determined for the (soluble) metal ions. The ERVs are based on the lowest EC50/LC50 values for algae, invertebrates and fish. Acute ERVs were obtained from the Metals classification tool (MeClas) database as follows: The acute ERVs for aluminium are 1,040 µg Al/L at pH 6 and 3,390 µg Al/L at pH 8 whereas the acute ERV for manganese is 3,200 µg Mn/L. Thus, the acute ERVs for aluminium and manganese ions are above 1 mg/L, respectively, and 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.” Further, the determined dissolved 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 short-term ERVs. Hence, 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).

In accordance with Figure IV.4 “Classification strategy for determining acute 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) aquatic hazard.

Manganese alumina pink corundum is poorly soluble and unlikely to cross biological membranes. In accordance with Annex VII, Column 2, Section 9.1.1. of Regulation (EC) 1907/2006, testing for short-term toxicity to invertebrates is not necessary.

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