Registration Dossier
Registration Dossier
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EC number: 203-438-2 | CAS number: 106-88-7
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The substance is not P/vP
In a CO2-Headspace Test according to ISO 14593 the substance was determined to be readily biodegradable in compliance with OECD criteria (80 - 90 % biodegradation based on CO2 evolution) fulfilling the 10-day-window criterion (see IUCLID section 5.2.1). The substance is therefore not considered P/vP.The substance is not B/vB
In an experimental study the log Kow of the substance was determined to be 0.68 at 25 °C (see IUCLID section 4.7), which is clearly below the indicated threshold value for bioaccumulation potential. Further, based on the structure and physicochemical properties of the substance the potential to cross biological membranes is low. The substance is hence considered not B/vB.The substance is not T
A chronic NOEC or EC10 value for feshwater or marine species is not available. However, for the freshwater algae D. subspicatus the 72-hour EC20 was determined to be 130 mg/L (nominal) (please refer to IUCLID section 6.1.5). The chronic EC10 or NOEC of the substance is thus considered to be significantly higher than the threshold value of 0.01 mg/L for T properties givenin Annex XIII of REACH. Further, the substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008. There is moreover no other evidence of chronic toxicity or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008. The substance is hence considered not T.
Conclusion
The substance does not fulfil the PBT or vP/vB criteria laid down in Annex XIII to Regulation 1907/2006 and in accordance with the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11 (version 3.0, June 2017).The substance was assessed to be not P/vP, not B/vB and not T. Based on the avaiable information the substance is regarded not PBT and not vPvB.
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