1-methyl-2-pyrrolidone

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Review

Data source

Reference

Reference Type:

publication

Title:

Richtwerte für 1-Methyl-2-pyrrolidon in der Innenraumluft

Author:

Umweltbundesamt

Year:

2014

Bibliographic source:

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz 57: 1232–1241

Materials and methods

Type of study / information:

(Translation:) Benchmark values for indoor air of NMP
The publication of the Federal Environmental Agency, summarizes the literature results on the following endpoints: Toxicokinetic, irritation, repeated-dose toxicity, toxicity to reproduction and genetic toxicity. For detailed information, please refer to the corresponding IUCLID section.

Test guideline

Qualifier:

no guideline followed

Test material

Test material information

Constituent 1

Reference substance name:

1-methyl-2-pyrrolidone

EC Number:

212-828-1

EC Name:

1-methyl-2-pyrrolidone

Cas Number:

872-50-4

Molecular formula:

C5H9NO

IUPAC Name:

1-methylpyrrolidin-2-one

Test material form:

liquid

Results and discussion

Any other information on results incl. tables

Toxicokinetics:
NMP is rapidly and substantially completely absorbed via the oral, dermal and inhalation route. Absorbed NMP is distributed in all organs and rapidley metabolized in the liver. The substance is largely excreted through the kidneys in the urine as metabolites (>80%; Main metabolites: 5-Hydroxy-N-methyl-2-pyrrolidon (5-HNMP), 2-Hydroxy-N-methylsuccinimid (2-HMSI)) and only a small proportion in the faeces (5%).
Irritation:
In some workplace studies NMP is an irritant to the human eye.
Reapeated dose toxicity:

In subacute and subchronic studies rats showed after exposure to NMP via inhalation effects at a concentration of 1000 mg/m³.

Toxicity to reproduction:
In reproductive toxicity studies with rats a decreased testicular weight, histopathological changes and cell loss in the germinal epithelium of the testis were found only at very high exposure doses to an aerosol vapour mixture of NMP (4 days with 7000 mg/m³, 2 weeks with 4000 mg/m³ or 3 weeks with 3000 mg/m³). Developmental toxicity was observed at a dose of 680 mg NMP/ m³ (whole body exposure) in rats. This dose resulted in increased resorption, decreased fetal weight and delayed ossification. The offspring of exposed animals showed a delayed development at 620 mg/m³. Additional studies with NMP and its major metabolites showed that the embryotoxic and teratogenic effects can not be attributed to the metabolite. 
Genetic toxicity:
In several in vitro studies on different strains of Salmonella typhimurium no mutagenic effect of NMP was observed in the presence and absence of an exogenous metabolic activation system (rat oder hamster). In mammalian cell gene mutation assays, NMP also showed no mutagenic effect and no genetic toxicity was observed in in-vivo tests with NMP.