Sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate

PBT assessment

PBT assessment: overall result

Reference

Name:

sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate / sodium 1-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonate / 75277-39-3 / 278-169-7

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Reference substance:

sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate / sodium 1-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonate / 75277-39-3 / 278-169-7

PBT status:

the substance is not PBT / vPvB

Justification:

Assessment of P/vP properties
The substance is not readily biodegradable (reference 5.2.1-1). Additional information on the biodegradability of the substance is not available. Therefore, the substance has to be considered as vP (and P).

 

Assessment of B/vB properties
The log Kow of the test item was determined to be < -3.88 at 20 °C (reference 4.7-1). This value is clearly below the trigger value for bioaccumulation potntial of Log Kow > 4.5 cited in REACH Annex XIII. Therefore, the substance is not considered as B or vB.

 

Assessment of T properties
The non-toxicity of the read-across source and target substance, respectively, to aquatic species of three trophic levels was demonstrated in reliable guideline studies. The NOEC for green algae was ≥ 100 mg/L (see IUCLID section 6.1.5). The target substance is neither classified for short-term (acute) aquatic toxicity, nor for long-term (chronic) aquatic toxicity in accordance with the criteria laid down in Regulation (EC) No 1272/2008 (CLP Regulation) as last amended for the seventeenth time in Regulation (EU) 2021/849. In addition, 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 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. There 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 (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.

 

Conlusion
The substance is not readily biodegradable. As no degradation half-life or information from other screening tests (e.g. enhanced ready biodegradability, inherent biodegradability test) is available, the substance has to be regarded as vP (and P). The log Kow of the substance is clearly below the threshold value for bioaccumulative potential of Log Kow > 4.5 and is thus not considered as B or vB. The substance does not fulfil the criteria for T properties in accordance with Annex XII of Regulation (EC) No 1907/2006 (REACH). Therefore, the substance is determined not to be PBT or vPvB.