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Toxicological information

Skin irritation / corrosion

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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:
other: Meets generally accepted scientific standards, well documented and 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
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
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
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:
not irritating
Remarks:
Migrated information