Registration Dossier

Administrative data

Endpoint:
long-term toxicity to birds
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 Regulation (EC) 1907/2006, Annex X, Column 2, Section 9.6.1: “Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level.”

According to the ECHA Guidance on information requirements and CSA (Chapter R.16: Environmental Exposure Estimation, Version: 2.1, October 2012), there is not a need for a detailed assessment of secondary poisoning i) if there are not any indications for bioaccumulation and ii) if there is not a potential for toxic effects if accumulated in higher organisms (based on classification on the basis of mammalian toxicity data).

Regarding mammalian toxicity and the relevant uptake via the oral pathway, signs of systemic toxicity were not observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Either no or only marginal increases in Cr and Fe plasma concentrations were observed, documenting the lack of bioavailability of this pigment (Leuschner, 2018). Thus, based on currently available information, the potential for systemic toxicity in mammals is low. According to the integrated testing strategy for avian toxicity in Figure R.7.10-2 of ECHA guidance on IR & CSA, R.7c (V 3.0, 2017), a mammalian hazard and risk cannot be identified. Thus, testing of chromium iron hematite is not required.

According to ECHA guidance on IR & CSA, R.10 (2008); “Secondary poisoning is concerned with toxic effects in the higher members of the food chain, either living in the aquatic or terrestrial environment, which result from ingestion of organisms from lower trophic levels that contain accumulated substances. Previous cases have demonstrated that severe effects can arise after exposure of animals via their food and that bioconcentration, bioaccumulation and biomagnification in food chains need to be considered.”

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, including its low potential for bioaccumulation and biomagnification.

Regarding its essentiality, “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 an essential element, it is expected that internal chromium levels are homeostatically regulated by all living organisms. Chromium is not expected to biomagnify in aquatic or terrestrial food-chains.

Iron as essential element plays a crucial role in a wide variety of biological process, i.e. electron transport, nitrogen fixation and oxidative metabolism. As an essential component of haemoglobin, it functions as a carrier of oxygen in the blood and muscles of animals. The uptake of iron into cells is actively regulated by a strict homeostatic control system. The active regulation of iron uptake in combination with internal detoxification mechanism indicates a low potential for iron bioaccumulation. This assumption is supported by results of Bustamante et al. (2000) indicating that iron concentrations of digestive glands of cephalopods living in natural and in iron-enriched habitats are similar. Winterbourn et al. (2000) further demonstrate that iron does not biomagnify but rather “biodilutes” up the aquatic food chain. Thus, the potential for bioaccumulation of iron in aquatic and terrestrial environments can be expected to be low.

Based on available information, there is not any indication of a bioaccumulation potential for chromium iron hematite. In addition, the potential for systemic toxicity in birds and mammals is low. Hence, secondary poisoning is not considered relevant for chromium iron hematite. In accordance with Regulation (EC) 1907/2006, Annex X, Column 2, Section 9.6.1, testing of Chromium iron hematite does not appear to be scientifically necessary and it is further scientifically not justified to conduct any toxicity study with birds for reasons of animal welfare.

References:
Bustamante et al. (2000) Bioaccumulation of 12 trace elements in the tissues of the nautilus Nautilus macromphalus from New Caledonia. Marine Pollution Bulletin 40/8: 688-696.

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

Winterbourn et al. (2000) Aluminium and iron burdens of aquatic biota in New Zealand streams contaminated by acid mine drainage: effects of trophic level. The Science of The Total Environment 254, 45-54.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion