Registration Dossier
Registration Dossier
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EC number: 900-600-0 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
No experimental studies were conducted on the multiconstituent substance (Flux1). Instead, a constituent-based, Weight-of-Evidence approach, was performed.
The three major constituents were targeted, representing ca 95% of a typical composition (carbon tetrachloride (CAS n° 56-23-5), 1,2-Dichloroethane (CAS n°107 -06 -2) and chloroform (CAS n° 67-66 -3)). Numerous published data were available, and a single consensus value was selected for each, from a reliable source.
Based on a weight of evidence approach on data available on each constituent, the multiconstituent substance (Flux 1) is considered as not readily biodegradable as no biodegradation of two constituents has been observed with OECD tests (MITI Japan studies, 1992) and none of the constituents are expected to biodegrade rapidly (QSAR Biowin).
As a consequence, Flux1 is considered as not readily biodegradable and fulfills potentially "P/vP" criterion of PBT assessment.
Based on a weight of evidence approach on experimental data available on each constituents, the multiconstituent substance (Flux1) is considered as not bioaccumulable and does not fulfill B criterion of PBT assessment (for each constituent: BCF<13 and logKow<4.5).
Based on a weight of evidence approach on data available on each constituents, the long-term NOEC/EC10 of each constituents is higher than 0.01 mg/L. However, carbon tetrachloride is classified as carcinogenic 2 and STOT RE category 1, DCE is classified as carcinogenic 1B and Chloroform is classified as STOT RE category 1, carcinogenic 2 and reprotoxic 2 according to Regulation EC No 1272/2008.
Based on the concentrations of carbon tetrachloride, DCE and Chloroform (>0.1%) in the substance and its CMR classification, Flux1 fulfills the T criterion of PBT assessment.
Based on a weight of evidence approach on experimental data available on each constituent, the multiconstituent substance (Flux 1) fulfills potentially the "P/vP" crtiterion and fulfills "T" criteria but neither the "B" nor "vB" criteria. According to R11 Guidance, the data must show that all three criteria are met in the case of PBT, or both vP and vB criteria in the case of vPvB.
In conclusion, the multiconstituent substance (Flux1) is not PBT/vPvB.
- Likely routes of exposure:
The main constituents of Flux1 are not expected to come into contact with humans via dermal or oral contact due to the PPE and procedures used in on-site handling operations. Nevertheless the constituents of the substance are volatile and may escape to as mall degree via a duct in th storage tank and this has been taken into account in the risk assessment
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