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Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

The PBT Assessment is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2014).

Persistence:

Triafamone will be fully mineralized under environmental conditions by microbial activity within a short time period (DT50 < 10 days). This was proven for several soil and water/sediment simulation studies according to OECD guidelines 307/308. Thus, the test substance does not meet the screening criterion for persistency and is not considered to be persistent (P) or very persistent (vP).

Bioaccumulation:

Triafamone has a log Kow of 1.5 (OECD 107). Thus, the substance does not meet the screening criterion for bioaccumulation and is not considered to be bioaccumulative (B) or very bioaccumulative (vB).

 

Toxicity:

Chronic toxicity data are available for algae, but not for fish and daphnids. The NOEC for algae is > 0.01 mg/L (NOEC = 0.096 mg/L; nominal, based on growth inhibition of Pseudokirchnerella subcapitata). The lowest acute value is clearly greater than 0.1 mg/L (EC50 = 6.23 mg/L; nominal, based on growth inhibition of Pseudokirchnerella subcapitata).

Triafamone is not classified as carcinogenic (Cat. 1 or 2), mutagenic (Cat. 1 or 2), or toxic for reproduction (Cat. 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (Cat. 1A or 1B), germ cell mutagenic (cat. 1A or 1B), or toxic for reproduction (Cat. 1A, 1B or 2) according to Regulation (EC) No. 1272/2008. However, Triafamone is classified as STOT RE Cat. 2 according to Regulation (EC) No. 1272/2008. Thus, the criterion set out in Annex XIII of Regulation

(EC) No. 1907/2006 is met and the test substance is considered to meet the T criterion.