Registration Dossier

Administrative data

Endpoint:
activated sludge respiration inhibition testing
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
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Annex VIII, Column 2, Section 9.1.4. of Regulation (EC) 1907/2006, the test for activated sludge respiration inhibition 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”.

Chromium iron hematite 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 (Pardo Martinez, 2010) that indicate a very low release of pigment components. Transformation/dissolution of chromium iron hematite (24-screening test according to Oecd Series 29, loading of 100 mg/L, pH 6 and 8) resulted in metal concentrations that are below the respective LODs for iron and chromium (< 0.5 µg/L). Dissolved metal concentrations remained also below the respective LOD after 7 days with 1 mg/L (and also 100 mg/L) and after 28 days with 1 mg/L at pH 6. Thus, the rate and extent to which chromium iron hematite produces soluble (bio)available ionic and other chromium- 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 chromium iron hematite is expected to determine its behaviour and fate in the environment, and subsequently its potential for ecotoxicity.

Proprietary studies are not available for chromium iron hematite. The poorly soluble substance chromium iron hematite 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 or NOEC/EC10 values for algae, invertebrates and fish. Acute and chronic ERVs were obtained from the Metals classification tool (MeClas) database as follows: For trivalent chromium and iron ions, the acute and chronic ERVs are above 1 mg/L, respectively, and a concern for short-term (acute) and 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 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 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.” Due to the lack of an acute and chronic aquatic hazard potential for soluble trivalent chromium and iron ions and the fact that dissolved chromium and iron concentrations were below the LOD of 0.5 µg/L after 7 and 28 days at pH 6 in the T/D test, respectively, it can be concluded that the substance chromium iron hematite is not sufficiently soluble to cause short- 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 chromium iron hematite is poorly soluble and does not meet classification criteria for acute (short-term) and chronic (long-term) aquatic hazard.

Chromium iron hematite is poorly soluble. Based on the poor solubility and the corresponding lack of a toxic potential, inhibition of activated sludge respiration or toxicity to microorganisms is not expected. In accordance with Annex VIII, Column 2, Section 9.1.4. of Regulation (EC) 1907/2006, the test for activated sludge respiration inhibition is not necessary.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion