Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity unknown

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals 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 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
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:
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 from a self-inflicted injury unrelated to test material administration.
Body weight:
Body weight gains were normal at all weighing periods.
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:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
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, systemic signs of toxicity 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 to the skin.