1-(2-hydroxyethyl)pyrrolidin-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Before OECD Guideline 404 was established, skin irritation was tested using an internal method (BASF test). Groups of two animals were treated for 1, 5, or 15 minutes or 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-hydroxyethyl)pyrrolidin-2-one

EC Number:

222-359-4

EC Name:

1-(2-hydroxyethyl)pyrrolidin-2-one

Cas Number:

3445-11-2

Molecular formula:

C6H11NO2

IUPAC Name:

1-(2-hydroxyethyl)pyrrolidin-2-one

Details on test material:

Name of the test substance used in the study report: 1-(2-hydroxyethyl)pyrrolidone-2
Test substance number: XIX/367

Test animals

Species:

rabbit

Strain:

Vienna White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact skin

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

about 1 ml

Duration of treatment / exposure:

1, 5 and 15 minutes and 20 hours

Observation period:

8 days

Number of animals:

2 per exposure duration

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin rinsed with Lutrol 50%
- Time after start of exposure: after treatment (1, 5 and 15 minutes and 20 hours)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(1 minute exposure)

Basis:

mean

Time point:

other: 24 hours

Score:

0

Max. score:

4

Remarks on result:

other: 1 minute exposure

Results 2

Irritation parameter:

erythema score

Remarks:

(5 and 15 minutes exposure)

Basis:

mean

Time point:

other: 24 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 5 and 15 minutes exposure

Results 3

Irritation parameter:

erythema score

Remarks:

(20 hours exposure)

Basis:

mean

Time point:

other: 24 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days. Already after 2 days, the erythema were very slight (score 1) in both animals.

Remarks on result:

other: 20 hours exposure

Results 4

Irritation parameter:

edema score

Remarks:

(1, 5, 15 minutes and 20 hours exposure)

Basis:

mean

Time point:

other: 24 hours

Score:

0

Max. score:

4

Remarks on result:

other: 1, 5, 15 minutes and 20 hours exposure

Irritant / corrosive response data:

After a 20 hours occlusive exposure to the undiluted substance a erythema score 2 was reported for both animals. After 8 days, all findings had disappeared. Already after 2 days, the erythema were very slight (score 1) in both animals. So, the scores triggering classification would not have been reached. Considering the stringent application conditions (20 hours, occlusive, no rinsing), the substance is assessed to be non-irritant to the skin according to regulatory criteria.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met