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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 biodegradation of tetrabutyl urea was investigated in a study conducted according to OECD Guideline 301 F. The substance proved to be not readily biodegradable under the test conditions employed (<=1.3% biodegradation after 28 d). In the toxicity control containing both test and reference item 32.2% biodegradation occurred within 14 d thus indicating that the test item was not inhibitory to the inoculum at the concentration tested. Tests on the inherent biodegradability are not available.

Experimentally derived results on the bioaccumulation of tetrabutyl urea are not available. Based on a measured partition coefficient n-octanol/water coefficient (log Kow) of 6.2 (at 25°C) and a calculated log Kow of 5.69 (at 25°C), a high bioaccumulation could expected. However, based on calculated bioaccumulation factors (BCF) of 112 L/kg ww (regression based method) and 166 (Arnot-Gobas method) a low potential for bioaccumulation is to be assumed.

Based on the results on short-term toxicity of tetrabutyl urea to aquatic organisms, the lowest L(E)C50 was determined to be >0.1 mg/L in short-term toxicity testing.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 the DSD) 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 (or CLP Regulation). 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 is available.

These data indicate that tetrabutyl urea is not to be regarded as a substance exhibiting PBT or vPvB properties according to the criteria of REACH Directive, Article 14.3 (d) and the Technical Guidance Document (TGD) R.11 of the European Chemicals Agency.