Registration Dossier
Registration Dossier
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EC number: 203-002-1 | CAS number: 102-06-7
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Administrative data
Description of key information
Additional information
In an avian study performed on three species of song bird at a limit concentration of 100 mg/kg, no effects were observed. Indeed, DPG showed no acute toxicity to 3 song bird species:Agelaius phoeniceus, Sturnus vulgaris and Passer domesticus. After a 2-6 weeks adaptation phase, wild-caught birds received a single oral administration of the compound dissolved in propylene glycol. The LD50 for all three species was above the highest administrated dose of 100 mg/kg bw.
A terrestrial plant study conducted on monocotyledons and dicotyledons did not show a high level of concern for DPG in these species (Brassica rapa: EC50 = 358 mg/kg; Avena sativa: EC50 = 1169 mg/kg). This study is used for PNEC derivation.
We applied the EPM strategy to soil risk assessment, following the rules set out in the integrated testing strategy (ITS) detailed insection R.7.11.6., Chapter R.7c of the ECHA Guidance on information requirements and chemical safety assessment (version 2.0, November 2014). Only one relevant terrestrial toxicity datum is available for derivation of a PNECsoil. Therefore, a “soil hazard category” was assigned to DPG. DPG is not very toxic to aquatic organisms and is readily biodegradable. In addition, both partition and adsorption coefficients (both inferior to 3) allows considering DPG as not very adsorptive. DPG falls therefore within the scheme of “Hazard category 1”, which states that only the EPM method is required for the screening assessment. When PEC/PNECscreen is inferior to 1, then “no toxicity testing for soil organisms need to be done”, as stated in the R.7c Guidance. The new RCRs derived with both the EPM method and the available toxicity datum to plants are inferior to 1 for the terrestrial compartment. This information is presented in the updated CSA. Therefore, following the rules set out insection R.7.11.6., Chapter R.7c of the ECHA Guidance on information requirements and chemical safety assessment (version 2.0, November 2014), and in accordance with the REACh regulation EC 1907/2006 annexes IX and X, section 9.4, column 2, no additional testing on terrestrial organism is needed.
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