Registration Dossier
Registration Dossier
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EC number: 940-936-5 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The substance is a multi-constituent containing tetramethylammonium hypochlorite and tetramethylammonium chloride as the main components. The substance is only marketed and used in liquid mixtures with water content approx. 71 %. The intrinsic properties are related to the available chlorine concentration of the substance. Bio-degradation is not an important fate process for the substance. Target substance is miscible with water and decomposes at high concentration. The rate of the chemical decomposition and the formation of the different reaction products are dependent on the pH of the surrounding environment. Based on the chemical composition, by products and the high reactivity of the substance it is not considered as persistent or very persistent.
The bioconcentration factors and bioaccumulation factors were estimated for the three most abundant constituents of the substance according to the available analytical information. The values were calculated by using the BCFBAF v3.01 estimation tool (US EPA 2014). Based on the estimated BCF/BAF value (3.16 L/kg for the main constituent) and the known abiotic degradation pathways of the free chlorine in the target substance, the substance is not expected to be bioaccumulative.
The NOEC value 125 µg/l from GLP compliant algae growth inhibition study (OECD 202) does not indicate the toxicity. Furthermore, this substance is not mutagenic, carcinogenic or toxic to reproduction based on the GLP compliant OECD studies conducted for the target substance or read-across studies on the analogue chlorinated bleaching agents (sodium hypochlorite). Based on the results from the OECD 422 study, the substance need to be classified for repeated dose toxicity Category 2 (STOT-RE2 H373) and Xn; R48/20/21/2 in accordance with the criteria of CLP Regulation 1272/2008 and the EU directive 67/548/EEC. Therefore, this substance meets the toxicity criterion (T), but does not fulfil the PBT or vPvB criteria.
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