Registration Dossier
Registration Dossier
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EC number: 442-450-4 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence (P) Assessment
The substance is not readily biodegradable. No further information on the persistence of the substance is available. Taking the only information into account that the substance is not readily biodegradable the substance potentially meets the P and v-P criterion in a worst case approach.
Bioaccumulation (B) assessment
No bioaccumulation through aquatic exposure into fishes was observed in a experimental study. In addition, the BCF was predicted using different QSAR approaches recommended in ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance (ECHA, 2017), Table R.7.10-1: BCF Meylan Model v1.0.3, BCF CAESAR model v2.1.14 and Arnot-Gobas model v1.0.0 implemented VEGA in v1.1.5 indicate the very low bioaccumulation potential of the substance due to the determined very low BCF values of 3, 9 and 0.89, respectively. All BCF values are clearly below 2000/5000. Thus, the substance does not meet the B/vB criteria.
Toxicity (T) assessment
Chronic aquatic data for algae does not indicate any effects. In addition,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. Thus, the substance does not meet the T-criterion.
Overall conclusion
Not PBT/vPvB
Justification:
According to Annex XIII of the REACH Regulation (EC) No 1907/2006, a PBT substance has to meet all three of the criteria for persistence, bioaccumulation and toxicity, as listed in part 1 of Annex XIII, and a vPvB substance has to meet all criteria for persistence and bioaccumulation, as listed in part 2 of Annex XIII. Based on the relevant data provided and discussed, the substance is not identified as PBT or as a vPvB substance.
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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