Registration Dossier
Registration Dossier
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EC number: 217-168-8 | CAS number: 1761-71-3
Endpoint summary
Administrative data
Description of key information
Additional information
The chemical safety assessment for PACM (4,4'-methylenebis(cyclohexylamine)) demonstrates that 1) the exposure levels estimated in all relevant scenarios do not exceed the appropriate soil PNEC (calculated from aquatic toxicity data based on equilibrium partitioning), and 2) the likelihood and severity of an event occurring due to the physicochemical properties of the substance is negligible. Specifically, all risk characterization ratios are significantly under 1.0, and direct and indirect exposure to soil is unlikely as demonstrated by the attached exposure assessments.
Therefore, it is judged that further testing on terrestrial organism (soil macro organisms, terrestrial arthropods, terrestrial plants and soil microorganisms) is not necessary in accordance with Annex XI Section 3 as well as Annex IX 9.4, column 2 and Annex X 9.4, column 2.
Evaluation of long-term or reproductive toxicity to birds is not of concern for PACM (4,4'-methylenebis(cyclohexylamine. An acceptable database of repeat dose oral toxicity data is available for mammals and the log Kow for PACM is 2.03, and the BCF for PACM is: BCF < 60 (read across) 3.72 (Catalogic v.5.14.1.5, BCF base-line model v.04.11). All three values do not trigger an evaluation of the upper trophic level in particular toxicity to birds.
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