Registration Dossier
Registration Dossier
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EC number: 945-746-6 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The registered substance is not readily biodegradable. In addition, the biodegradation result obtained after 60 days (2% biodegradation) do not allow to conclude that the registered substance is not persistent in the environment. However, in one screening test with activated sludge and lowest test substance concentration, >60% biodegradation was achieved. Therefore, the registered substance would ultimately biodegrade after a long period of time (biodegradation > 60% after 168 days), even though the substance meets the persistence criterion (applying Annex XIII REACH Criteria).
The registered substance seems to be bioaccumulable (log Kow >4.5 and BCF > 2000 L/kg) but not very bioaccumulable (BCF < 5000 L/kg) based on the log Kow and estimated BCF values. However, at pH in the stomach of fish (generally comprised between 2 and 5), hydrolysis of the registered substance occurred (unstable at pH <=5) before biotransformation in liver, and the BCF of the hydrolysis product / metabolite at acid pH is considerably low (BCF = 12.9 L/kg according to OASIS QSAR). Therefore, we can conclude that the registered substance is non bioaccumulable.
Finally, for the T criterion, no data are available in chronic conditions except the algae result, with an experimental ErC10 value at 3.510 mg/L (so > 0.01 mg/L). 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 and no other evidence of chronic toxicity was observed, as identified by the classification specific target organ toxicity after repeated exposure (STOT RE Category 1 or 2) according to Regulation EC No 1272/2008. In addition, the most sensitive species in acute conditions is the aquatic invertebrate with an experimental 48h-EC50 value at 5.163 mg/L (so > 0.1 mg/L). Therefore, the registered substance is presumably not Toxic.
In conclusion, the registered substance cannot be considered PBT or vPvB.
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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