Registration Dossier
Registration Dossier
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EC number: 682-238-0 | CAS number: 1190931-27-1
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Ammonium difluoro{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4- yl]oxy}acetate
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Related composition:
- Ammonium difluoro{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4- yl]oxy}acetate
- Reference substance:
- Ammonium difluoro{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4- yl]oxy}acetate
- Reference substance:
- Ammonium difluoro{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4- yl]oxy}acetate
- Reference substance:
- Ammonium difluoro{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4- yl]oxy}acetate
- Reference substance:
- Ammonium difluoro{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4- yl]oxy}acetate
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The substance is not expected to significantly degrade neither by biotic or abiotic pathways and it is therefore considered persistent. If emitted to the environment it is expected to distribute mainly to the water compartment. In the aquatic environment, however, on the basis of the available experimental data, the substance is anticipated to not bioaccumulate and to not exert toxic effects in the aquatic organisms. The toxicokinetics studies in rats provided evidence of a short half-life in plasma (4 to 13 hrs in most studies), with the majority of the excretion via urine occurring usually within 24 hours. Based on the available data in mammals, there is no evidence of bioaccumulation.
The substance is however considered toxic for mammals as indicated by the results of the 28-day and 90-day oral studies in rats, where liver toxicity was observed at levels triggering a classification as STOT RE2 (Specific Target Organ Toxicity).
In conclusion, considering al the available data, the substance meets the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistent” and “Toxic”, but it does not meet the criteria for the “Bioaccumulation” endpoint. Therefore the substance is not considered to be neither a PBT nor a vPvB substance.
Reference
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