Registration Dossier
Registration Dossier
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EC number: 216-036-7 | CAS number: 1478-61-1
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Boundary Composition - 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Type of composition:
- boundary composition of the substance
- State / form:
- solid: particulate/powder
- Reference substance:
- Boundary Composition - 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Related composition:
- Boundary Composition - 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Reference substance:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- PBT status:
- the substance is not PBT / vPvB
- Justification:
In accordance with the criteria for PBT assessment, described in Annex XIII of the REACH Regulation, the substance is not considered to tbe PBT or vPvB.
Based on screening criteria, persistence cannot be ruled out as no biodegradation was observed in a ready biodegradability screening test conducted in accordance with OECD 301B (Anon., 2018). The substance meets the toxicity criteria as it is classified as a category 1B reproductive toxicant and category 2 Specific Target Organ Toxicant following repeated exposure (STOT RE-2).
The substance does not meet the criteria to be considered bioaccumulative. The log n-octanol/water partition coefficient, measured in accordance with OECD 117 (HPLC) was <4.5 (measured log Pow = 2.79). Additionally, a measured BCF in fish of 9.8 L/kg (OECD 305) confirms the screening level conclusion that the substance is not considered to be bioaccumulative in aquatic organisms. Regarding the air-breathing organisms, the combination of log Koa (determined at 11.54) and log Kow (2.79) indicates a potential to bioaccumulate but the toxicokinetics data on the substance showed that BPAF was “eliminated completely at 48 hrs” following oral dosing in rats, and was metabolized quickly. Recent toxicokinetics studies in rats and mice found plasma elimination half-lives of less than 4.22h in rats and mice, and extensive conjugation leading to low bioavailability. These data indicate that the substance, BPAF, is not likely to bioaccumulate in mammals too.
As the substance is not considered bioaccumulative, it does not meet the PBT or vPvB criteria.
- Likely routes of exposure:
Emission characterisation is not required in this context as the substance is not PBT or vPvB. However, full emission scenarios for identified uses of this substance are presented in the exposure assessment conducted as part of the chemical safety assessment, conducted in accordance with Annex I, Section 5 of the REACH Regulation.
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Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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