1-methyl-2-pyrrolidone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The test parameters documented do not totally comply with the specific testing guideline.

Data source

Reference

Reference Type:

publication

Title:

The acute oral toxicity and primary ocular and dermal irritation of selected N-alkyl-2-pyrrolidones

Author:

Ansell JM & Fowler JA

Year:

1988

Bibliographic source:

Fd. Chem. Toxicol. 26, No. 5: 475-479

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987-02-24

Deviations:

not specified

Remarks:

No test doses are given, only LD50 discussed.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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

Specific details on test material used for the study:

- Source: GAF Chemicals Corporation, Wayne, NJ, USA
- Purity: >= 98%, with less than 0.5% of water

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: 200 - 300 g
- Fasting period before study: 18 - 24 h
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

None

Doses:

Not indicated, LD50 is given

No. of animals per sex per dose:

5 (No. of groups as described in the publication: 6)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: not specified, but animals that died were observed for gross necropsy
- Other examinations performed: clinical signs, pharmacological activity

Statistics:

The oral LD50 including 95 % confidence limits was calculated using the method of Litchfield and Wilcoxon (1949).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 150 mg/kg bw

Based on:

test mat.

95% CL:

3 100 - 5 560

Mortality:

Mortality is only given as LD50 value.

Clinical signs:

other: Ataxia and diuresis at high but sublethal doses (1/8 LD50).

Gross pathology:

Irritation of the pyloric and/or gastro-intestinal mucosa was typically noted with darkening of kidneys, liver and lungs in non-survivors.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

NMP is of low toxicity and the oral LD50 was 4150 mg/kg bw (95 % confidence limits: 3100 - 5560 mg/kg bw).

Executive summary:

The acute oral toxicity of NMP was investigated in male and female Sprague-Dawley rats. The animals were administered graded doses of the neat test substance and observed for 14 days. Clinical signs at high but sublethal doses included ataxia and diuresis (at 1/8 LD50). The oral LD50 was 4150 mg/kg bw (95 % confidence limits: 3100 - 5560 mg/kg bw). NMP is of low toxicity based on the oral LD50 and will not be classified under Regulation (EC) No. 1272/2008 but it has to be considered that a classification for low acute toxicity category 5 defined under UN GHS might be applicable.