Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Toxicity to terrestrial organisms

In Annex X section 9.4 of Regulation (EC) No 1907/2006, it is laid down that tests on terrestrial organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on terrestrial organisms. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Regulation 1272/2008 or is assessed to be a PBT or vPvB. The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance.

Furthermore, according to Annex X section 9.4 of Regulation (EC) No 1907/2006, those studies do not need to be conducted if direct or indirect exposure of the soil compartment is unlikely. The substance is considered to be used only industrially. Therefore, direct exposure to the soil compartment is unlikely. Furthermore, an indirect exposure to the soil compartment via sewage sludge transfer is additionally unlikely, since the substance is readily biodegradable according to OECD criteria (MITI, Japan, 1992). For a substance being considered as "readily biodegradable", it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to the soil compartment is not expected. In addition, adsorption of the substance to the solid soil phase is not expected based on the low n-octanol/water partition coefficient (experimental log Kow = -0.46; BASF AG, 1988). In summary, no significant exposure of the terrestrial compartment is expected. Additionally, due to its low log Kow an accumulation of the substance in terrestrial organisms is not expected.

Therefore, no further tests on terrestrial organisms are provided.


Toxicity to terrestrial arthropods

Data from several tests on the toxicity of NMP to adults and larvae of honey bees (A. mellifera) are available.

However, the test design of these studies is not suitable for regulatory purposes under REACH. The studies are, therefore, disregarded since the methods do not correspond to current standards.

Therefore, the derivation of PNECsoil is based on the Equilibrium Partitioning Method (EPM).

Toxicity to birds

The acute toxicity of 1 -Methyl-2 -pyrrolidone (CAS 872 -50 -4) to birds was investigated in a study conducted according to EPA guidelines for hazard evaluation, using mallard duck as test organism (GAF Corp., 1979). After 5 days, no mortality or reduction in food consumption was observed up to the highest tested level of 5000 mg/kg diet (LD50 > 5000mg/kg diet), corresponding to 74.8 mg/kg body weight.