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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

The biodegradation of OECD 301 test on the test item indicates a biodegradation at 25%. This is sufficient to decide that the test item does not meet the P and vP criteria (Chapter R11 PBT Assessment, ECHA Guidance).

 

Bioaccumulation

A bioconcentration study was performed on the reaction mass of N-[2-(2-oxo-1-imidazolidinyl)ethyl] methacrylamide and methacrylic acid in accordance with the Japan guideline and OECD Guideline 305C. The BCF obtained was below to 5.3.

According to Chapter R11 PBT Assessment, the substance does not meet the B and vB criteria.

 

Toxicity

No toxicity data on fish, aquatic invertebrates and algae have been reported for this substance. But there is no evidence to have a NOEC < 0.01 mg/L for long term toxicity tests.

The substance does not meet T criteria for environmental compartment.

 

Otherwise, the substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1or 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. Besides, there is no evidence that the substance exhibits 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.

 

General Conclusion

According to Annex XIII of the REACH Regulation,the Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide does not meet the PBT or vP/vB criteria.