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PBT assessment

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PBT assessment: overall result

Reference
Name:
2-pyrrolidone
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistency (v / vP properties):

The assessment of persistence is based on available half-life data of the substance in water, sediment and soil compartment. Persistency in the natural environment is not relevant for the test substance. According to the obtained results, 2-pyrrolidone is readily biodegradable and hence, rapid degradation of 2-pyrrolidone in surface water, sediments and soils has to be expected. These results are confirmed by a published study of Shaver (1984): Biodegradation of the analogue substance NMP in soil was examined in a field test with three different types of soil (clay, sand and loam). After 21 days the level of extractable NMP was below 0.1 mg/kg soil, which corresponds to a degradation of higher than 90 %. Additionally, photodegradation (DT50 in air = 10.8 h), is a main degradation process for 2-pyrrolidone, preventing accumulation of this substance in the environment. Taking also into account the very low Bioconcentration factor (BCF = 3.2, see section 7.1.2), which was derived based on an octanol-water coefficient of only -0.71 (BASF, 1988), persistence of the test substance in environmental compartments or organisms can be ruled out and the test substance is assignet as not P and not vP.

Bioaccumulation (B / vB properties):

Possible bioaccumulation of a chemical substance in the biotic environment is characterised by means of measured data on bioaccumulation in aquatic species. The trigger value is a bioconcentration factor (BCF) of < 2000. There were no experimental data considering possible bioaccumulation of 2-pyrrolidone in aquatic or terrestrial compartments. The value for octanol-water coefficient (log Pow) was determined with -0.71 (BASF, 1988), indicating no lipophilic properties. Due to this extremely low logPow value there is no necessity to perform any experimental study. Since for 2-pyrrolidone a very low bioconcentration factor (BCF = 3.2) was calculated by aid of US-EPA software tool EPI-Win, any potential for bioaccumulation in aquatic organisms can be ruled out and the test substance is assigned as not B and not vB. These results are supported by the outcome of available metabolism studies.

Toxicity (T properties):

The toxicity (T) criteria of PBT assessment takes into account the long-term aquatic toxicity of a substance (trigger value: NOEC < 0.01 mg/L). Experimental results are available for three trophic aquatic levels, i.e. for fish, daphnids and algae. The available test results for acute aquatic toxicity are completed by QSAR calculations to estimate possible long-term effects of 2-pyrrolidone on fish and daphnids. For these calculations the scientifically accepted US-EPA software tool EPI-Win (ECOSAR) was used. Based on the results of the toxicity tests with aquatic organisms and the supporting QSAR calculations, it can be concluded, that the test substance shows only low toxicity to organisms of the aquatic compartment. Further criteria for assigning T criteria in a PBT assessment are a classification as 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 evidence for chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008. The criteria carcinogenicity or mutagenicity are not fulfilled. However, the test substance has been shown to be toxic to reproduction (Cat 1B) and 2 -pyrrolidone is therefore assigned as T.

Conclusion:

2-Pyrrolidone does not fulfill all of the relevant criteria for a PBT- or vPvB-substance, respectively. On the one hand, the criteria for T are fulfilled (Reprotoxic Cat 1B). However, due to the lack of persistency as well as negligible bioaccumation potential, 2-pyrolidone is not considered as a PBT substance. Based on the PBT assessment it can be concluded that 2-pyrrolidone is not PBT or vPvB. There is no necessity for further testing with 2-pyrrolidone to identify one of these inherent chemical properties.