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With regard to terrestrial toxicity of the pigment, the assessment and corresponding data are primarily based on the ecotoxicologial properties of lead. This justifiable since 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 physico-chemical properties and low bioavailability of the substance. The substances (all iron oxides) are highly insoluble in water, out of toxic response to aquatic organisms and do not have a potential for adsorption. Oxides of iron, derived from natural sources, occur in sediments and ron is an essential element 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. With regard to lead, a plethora of high quality ecotoxicological studies for quite a number of taxonomic groups are available, Because of the availability of multiple toxicity data for various species and processes, the statistical extrapolation method is used to derive the PNEC value for terrestrial organisms. The species sensitivity distribution is based on 105 NOEC and EC10 values covering 14 different plant species, 5 invertebrate species and 5 microbial functional processes. The NOEC and EC10 values of the 3 groups (higher plants, invertebrates and microbial processes) overlap in the frequency distribution, suggesting that the sensitivity range of these organisms is comparable.

All toxicity data were corrected for differences in toxicity between laboratory and field conditions. When available, good quality toxicity data derived in leached and aged soils are preferred. Only when no reliable data are available for corresponding leached and aged soils, toxicity data for leached or freshly spiked soils are also included. This datasets consists of 14 individual high quality bounded EC10 or NOEC values derived in aged soils, 35 results from spiked and leached soils and 56 results from freshly spiked soils. Data from leached soils without ageing were corrected with an additional ageing factor of 2.0, while data from freshly spiked soils without leaching or ageing treatments were corrected with a generic leaching/ageing factor of 4.0.

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