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Long-term toxicity to fish

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In accordance with column 2 of REACH Annex IX the long-term toxicity testing on fish shall be proposed if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.
MDI is rapidly hydrolysed in aqueous solution. However, MDI is hydrophobic and poorly soluble in water and thus the heterogeneous reaction with water or soil is less rapid. The major product of such a reaction is insoluble polyurea.
In the production of PMDI the formation of insoluble polyurea would cause abrasion prob-lems and blockage of valves and pipes and therefore releases of PMDI to effluents are expected to be non-existent. Since production is performed in closed systems, releases to soil and sediment are also expected to be negligible. Furthermore, the EUSES pro-gram has been used to calculate PEC values based on measured emission data provi-ded by PMDI producers and processors, including polyurethane producers (EU MDI Risk Assessment Report: methylenediphenyl diisocyanate (MDI)). Calculated PEC values we-re 1.4 x 10-6 mg/l for water, 6.9x 10-5 mg/kg for sediment and ranged from 4.2 x 10-5 to 7.2 x 10-4 mg/kg for soils/grassland. The corresponding PEC/PNEC ratios would be extremely small and less than 1.
In a supporting study (Heimbach, 1993) results suggest that PMDI, at loadings up to 10,000 mg/L, has no direct toxic effect on the fish Oncorhynchus mykiss.
Taking into account the scientific and exposure arguments, it appears appropriate to wai-ver the long-term fish/plant/soil and sediment toxicity studies.

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