Registration Dossier
Registration Dossier
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EC number: 444-960-2 | CAS number: 39148-16-8
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Fosetyl-Sodium
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: bulk
- Reference substance:
- Fosetyl-Sodium
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence (P) Assessment
Fosetyl-Sodium is not readily biodegradable according to the OECD 301D criteria, however, the substance was assessed as inherently biodegradable according to OECD guideline 302C (86.9% biodegradation after 28 days (BOD), and > 99.9% biodegradation after 28 days (residue analysis). Therefore, the substance does not fulfil the P or vP criteria.
Bioaccumulation (B) assessment
Fosetyl-Sodium has a log Pow of - 2.5 at 25±1 °C (OECD 107), which is below the relevant trigger value of 4.5.
Therefore, the substance does not meet the B criterion.
Toxicity (T) assessment
From the ecotoxicity perspective, the toxicity criterion is not met for the substance with a lowest NOEC of 10 mg/L (Daphnia magna) being above the ecologically relevant NOEC triggers of 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. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. The substance is does not to meet the T criterion.
Overall conclusion
Fosetyl-Sodium is 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.
Reference
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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