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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:

The PBT Assessment for the substance sodium methylparaben (CAS No. 5026-62-0) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2008).

Persistence

Sodium methylparaben is readily biodegradable in one study according to OECD 301B and OECD 301F (89 – 92.2% (ThCO2, ThO2) after 28 d). Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be persistent (P) or very persistent (vP).

Bioaccumulation

Sodium methylparaben has a log Kow of –0.63 (OECD 107). Thus, the test substance does not meet the screening criterion for bioaccumulation and is not considered to be bioaccumulative (B) or very bioaccumulative (vB).

Toxicity

Valid chronic toxicity data are available for Daphnia magna and the alga Pseudokirchneriella subcapitata with the lowest NOEC of 0.2 mg/L for Daphnia magna. Therefore, sodium methylparaben needs to be classified and labelled as environmental hazard Chronic Cat. 3 according to the Regulation (EC) No. 1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2ndATP).

Nevertheless, the test substance is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (2nd ATP). Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.

Sodium methylparaben is not classified as carcinogenic, mutagenic or toxic for reproduction according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (2nd ATP). Also, theres is 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 according to Regulation (EC) No. 1272/2008. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.