Registration Dossier
Registration Dossier
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EC number: 203-898-4 | CAS number: 111-71-7
Endpoint summary
Administrative data
Description of key information
Additional information
No terrestrial toxicity test is available for heptanal. Therefore, the EPM strategy was applied to soil risk assessment, following the rules set out in the integrated testing strategy (ITS) detailed in section R.7.11.6., Chapter R.7c of the ECHA Guidance on information requirements and chemical safety assessment (version 3.0, June 2017). No relevant terrestrial toxicity datum is available for derivation of a PNECsoil. Therefore, a “soil hazard category” was assigned to heptanal. Heptanal is not very toxic to aquatic organisms and is readily biodegradable. In addition, both partition and adsorption coefficients (both inferior to 3) allow considering heptanal as not very adsorptive. Heptanal falls therefore within the scheme of “soil Hazard category 1”, which states that only the EPM method is required for the screening assessment (and no terrestrial toxicity test). When PEC/PNECscreen is inferior to 1, then “no toxicity testing for soil organisms needs to be done”, as stated in the R.7c Guidance (v3.0 ; June 2017 ; p. 159). The new RCRs derived from the new freshwater PNEC with the EPM method are inferior to 1 for the terrestrial compartment. This information is presented in the updated CSA. Therefore, following the rules set out in section R.7.11.6., Chapter R.7c of the ECHA Guidance on information requirements and chemical safety assessment (version 3.0, June 2017), and in accordance with the REACh regulation EC 1907/2006 annexes IX and X, section 9.4, column 2, no testing on terrestrial organism is needed.
In addition, terrestrial toxicity testing is not technically feasible with volatile substances, as indicated in OECD 222 guideline on earthworm reproduction. As shown in aquatic tests (e.g. OECD 211), heptanal disappears rapidly and completely from the water medium within less than 24 hours, even with air-tight flasks with the smallest headspace achievable. Heptanal is a volatile organic compound (vapor pressure = 600 Pa > 10 Pa) and is rapidly degraded by hydroxy radicals in air (half-life = 4.5 hours according to Epiwin 4.11). Therefore, soil is not expected to be a compartment of concern. A quantitative risk assessment on soil is still carried out as a worst-case scenario. This risk assessment indicates no risk for the soil compartment.
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