Registration Dossier
Registration Dossier
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EC number: 203-931-2 | CAS number: 112-05-0
Endpoint summary
Administrative data
Description of key information
The chemical safety assessment identified no risk for the terrestrial compartment based on hazard assessment using the equilibrium partition method and supported by further considerations.
Additional information
In accordance with REACH Annex IX, 9.4, Column 2, the EPM method may be applied to assess the hazard for soil organisms. As the substance is readily biodegradable, not assumed to be highly adsorptive to soil (log Koc 2.15, no other indications of high adsorption), and of low aquatic toxicity (EC/LC50 >> 1 mg/L) the substance was assigned to soil hazard category 1, according to the ITS as described in ECHA Guidance on Information Requirements and CSA, R.7c. Applying the EPM method to assess the hazard for soil organisms, no risks were identified and in conclusion soil toxicity testing is not required.
Further, according to ECHA guidance document R.7c testing of soil microorganisms will be necessary only in case toxicity to STP microorganisms was observed; however, based on results from a valid study on Tetrahymena pyriformis (regarded as a sensitive representative), STP microorganism toxicity is low (IC50 71 mg/L; 40 h; growth) and still overestimated (pH induced toxicity), because the test system is reported to be sensitive to acidic pH (no growth anymore at pH <= 5.5; Schultz, 1997), the test item an acid, and test item solutions were not neutralized (explicitly reported). Concluding, soil microorganism toxicity is not to be expected and thus no further testing required.
Regarding toxicity to birds, in accordance with REACH Annex X, 9.4, Column 2, the available mammalian dataset may be used for the risk assessment (see Section 7). According to ECHA Guidance on Information Requirements and CSA, R.7c, risk from secondary poisoning is unlikely for a substance which is readily biodegradable, and has a low potential for bioaccumulation in fish and earthworms (which is the case with the submission substance: see IUCLID section 5.3). Available supporting studies on birds confirm the very low toxicity of nonanoic acid (LC/D50 > highest dose level for 2 species in three tests).
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