1-methyl-2-pyrrolidone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Dermal toxicity of dimethyl acetylene dicarboxylate, N-methyl pyrrolidone, triethylene glycol dimethyl ether, dioxane and tetralin in the rat

Author:

Clark B, Furlong JW, Ladner A & Slovak AJM

Year:

1984

Bibliographic source:

Int. Res. Comm. System Med. Sci. 12: 296-297

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

not specified

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

Details on test material:

no details given

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 196 - 237 g

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- % coverage: approximately 20 - 25 % of the body surface
- Type of wrap if used: occlusive dressing, elastic adhesive bandage backed with aluminium foil

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: following bandage removal after 24 hours

TEST MATERIAL
- Amount(s) applied: 2 mL at maximum

Duration of exposure:

24 hours

Doses:

1300, 2500, 5000, 10000 mg/kg bw

No. of animals per sex per dose:

2 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

1/2 males and 2/2 females treated at 10000 mg/kg bw died within 48 hours.

Clinical signs:

other: Hunched posture was noted at 2500 and 10000 mg/kg bw, lethargy was observed at 5000 and 10000 mg/kg bw

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value was >5000 mg/kg bw.

Executive summary:

The acute dermal toxicity of NMP was investigated in each 2 male and 2 female Sprague-Dawley rats. The rats were exposed to the undiluted test substance on shaved skin under an occlusive dressing for 24 hours. The animals were observed for 14 days for mortality and signs of toxicity. The LD50 value was >5000 mg/kg bw. NMP is of low toxicity based on the LD50 value determined for males and females.