Registration Dossier
Registration Dossier
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EC number: 831-109-9 | CAS number: 5837-73-0
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- MVG
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- MVG
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Assessment of P/vP properties
In a Closed Bottle Test according to OECD TG 301 D the test item was determined to be readily biodegradable (67.9 % based on theoretical oxygen demand (ThODNH3) meeting the 10-day window criterion. In accordance with the criteria given in Annex XIII of Regulation EC No 1907/2006 (REACH) the substance is not P (or vP).
Assessment of B/vB properties
An experimental study was performed to determine the water-octanol partition coefficient according to Regulation (EC) No 440/2008 Method A.24. and OECD Test Guidelines 117 using the HPLC method. The log Pow of the substance was measured to be < 0.3. The extrapolated log Pow was determined to be 0.13. This value is clearly below the threshold value for bioaccumulative potential of 4.5 stated in Annex XIII of Regulation (EC) No 1907/2006 (REACH). Therefore, the substance is not regraded B or vB.
Assessment of T properties
In a study according to OECD TG 201 with Raphidocelis subcapitata the 72-hour ErC10 based on growth rate was determined to be 1.70 mg/L. This value is clearly above the trigger value for toxic properties in accordance with Annex XIII of Regulation (EC) No 1907/2006 (REACH). Further, the substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or 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. No other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008 . It is hence concluded, that the substance does not fulfil the T criterion.
Conclusion
The substance does not fulfil the criteria for P/vP, B/vB or T properties. It is thus concluded that the substance is neither PBT, nor vPvB.
Reference
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