Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

No data are available on the effects of iron oxides on terrestrial organisms. However, in accordance with section 1 of REACH Annex XI, studies on terrestrial organisms do not need to be conducted, as the category members are inert inorganic oxides of iron which resemble naturally occurring iron oxides and based upon the physic-chemical properties and low bioavailability of the substance. The substances are highly insoluble in water, out of toxic response to aquatic organisms and the category members do not have a potential for adsorption. Oxides of iron, manganese, and zinc, derived from natural sources, occur in sediments. Iron, manganese and zinc are essential elements for humans, other animals, plants, and microorganisms. Synthetic iron oxide pigments have no relevant effect on the levels and bioavailabilities of these elements. Even under worst case conditions an inhibitory effect of synthetic iron oxide pigments is not likely to be exerted on soil organisms. For manganese and zinc ions, there is ample evidence that these metals are not toxic to terrestrial organisms.

Additionally, a comprehensive evaluation of whether the relative contributions of anthropogenic iron and aluminium to the existing natural iron and aluminium pools in soils and sediments are relevant in terms of added amounts and in terms of toxicity. The investigations were performed by ARCHE (Assessing Risks of CHEmicals) in 2010 and the results are laid down in the "White Paper on exposure based waiving for iron and aluminium in soil and sediments". The following conclusions are presented:

The justification for exposure based waiving of conducting additional soil and sediment tests should be based on information on absence of exposure or in the case of metals on information showing that the contribution of the anthropogenic emissions are overruled by the already present natural background. The information provided and discussed in the previous chapters clearly indicate that exposure based waiving is justified for iron and aluminium. The results indicate that the relative contribution of anthropogenic iron and aluminium to the already present natural iron and aluminium pool in soils and sediments is not relevant in terms of added amounts and in terms of toxicity.

Categories Display