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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 ready biodegradability of the substance was investigated in a study conducted according to OECD Guideline 301 B over a period of 28 days and using non-adapted activated sludge as inoculum source. The substance proved to be readily biodegradable and fulfilling the 10-d window criterion (92% biodegradation after 28 d).

Therefore, the substance does not fulfil the criteria for persistence (P).

 

Bioaccumulation

The partition coefficient n-octanol /water was not determined for the substance because the study is technically not feasible. However, the measured logKow of the main constituent is -2.94. Further, all other minor constituents have measured logKow well below 0.

Therefore, the substance does not fulfil the criteria for bioaccumulation (B).

 

Toxicity

According to Annex XIII of REACH Regulation (EC) No 1907/2006, a substance is considered to be toxic in terms of PBT criteria if long-term NOEC values for aquatic organisms are lower than 0.01 mg/L. Since no data for chronic toxicity of the substance is available, the assessment is based on the screening criteria referring to the aquatic short-term toxicity tests.

Acute aquatic tests on all three trophic levels (algae, invertebrates and fish) revealed a low toxicity of the substance with effect values (L(E)C50) > 100 mg/L.

 

According to Annex XIII of REACH Regulation (EC) No 1907/2006, a substance is considered to fulfill the toxicity criterion (T), if the substance is 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 (DSD) or as carcinogenic Cat. 1 A 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 (CLP-Regulation). This is not the case for the substance. Further, the substance does not exhibit any other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn according to Directive 67/548/ EEC (DSD) or specif target organ toxicity after repeated exposure (STOT RE Cat. 1 or 2) according to Regulation EC No 1272/2008 (CLP-Regulation).

 

Therefore, the substance does not fulfil the criteria for toxicity (T).