2-pyrrolidone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Peer reviewed database

Data source

Reference

Reference Type:

secondary source

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-pyrrolidone

EC Number:

210-483-1

EC Name:

2-pyrrolidone

Cas Number:

616-45-5

Molecular formula:

C4H7NO

IUPAC Name:

pyrrolidin-2-one

Details on test material:

Purity not stated

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Following a quarantine period of at least one week, five healthy male and five healthy female New Zealand Albino rabbits were randomly assigned to the treatment group. The pretest weight range was 2.3 -2.6 kg for males and 2.1 -2.5 kg for females. The animnals were housed 1/cage in suspended wire mesh cages. Bedding was placed beneath the cages andchanged twice/week. Fresh Purina Rabbit Chow Diet (Diet #5321) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rabbits on acute tests, was termperature controlled, had a 12 hours dark/light cycle.

The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity. The test article was applied to the prepared dermal site, one time, by syringe type applicator at a dose level of 2.0 g/kg. The test site was covered with a gauze patch, secured with non-irritating tape and gentle pressure was applied to the gauze to aid the distribution of the test article over the area. The torso was wrapped with plastic that was secured with non-irritating tape. At 24-hours after initiation, the patches were removed and residual test article was removed with distilled water.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
At 24 hours after initiation, the patches were removed and residual test article was removed with distilled water.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

The animals were observed 1, 2 and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. Animals were observed twice daily for 14 days for mortality. The test sites were scored for dermal irritation at 24 hours post dose and on days 7 and 14 using the numerical Draize scale. Body weights were recorded pretest, weekly and at death or termination. All animals were examined for gross pathology. Abnormal tissues were preserved in 10 % buffered formalin and saved for possible future microscopic examination.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived the 2000 mg/kg dermal application.

Clinical signs:

other: There were no abnormal systemic signs noted in 9/10 animals. One male exhibited red staining of the nose/mouth area and an apparent cataract in the right eye on day 5, with the ocular abnormality persisting through day 14 but this was considered to result

Gross pathology:

Necropsy did not reveal any treatment related changes.

Other findings:

IRRITATION EFFECTS
Dermal reactions were slight to well-defined on day 1 but were absent on days 7 and 14.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

2-pyrrolidone is nontoxic to the rabbit skin.

Executive summary:

The study was performed according to the OECD Guideline 402 and is comliant to the GLP requirements. The 5 albino New Zealand White rabbits were administered dermal to a single dose of 2 -pyrrolidone at dose level of 2000 mg/kg/bw under occlusive conditions for 24 h. There were no deaths, no test substance-related systemic signs of toxicity (no abnormal systemic signs noted in 9/10 animals. One male exhibited red staining of the nose/mouth area and an apparent cataract in the right eye on day 5, with the ocular abnormality persisting through day 14 but this was considered to result from a self-inflicted injury unrelated to test material administration) and no treatment related changes at necropsy. The body weight gain was normal. The dermal reactions were slight to well-defined. Such reactions are considered to be adaptive in nature. 2 -pyrrolidone is not toxic after dermal exposure for 24 h (LD50 > 2000 mg/kg bw) and does not have to be classified.