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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

Constituent 1
Chemical structure
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:
Ataxia and diuresis at high but sublethal doses (1/8 LD50).
Body weight:
No data.
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.

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