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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented, acceptable study report which meets generally accepted scientific standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hydroxypropyl acrylate
- Analytical purity: 95 %

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped (intact and abraded)
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 hr
Observation period:
48 hr
Number of animals:
Six rabbits were treated on the intact skin, the other six on the abraded skin. (The abrasions were minor incisions through the stratum corneum,
but not sufficiently deep to disturb the derma or to produce bleeding.)
Details on study design:
TEST SITE
- Area of exposure: 1 inch X 1 inch of the back
- Type of wrap if used: The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Draize scoring system (Draize, J. Pharmacol. 82: 377 - 390, 1944)
Readings of skin reactions were performed at 24 (immediately after removal of the test patches) and 72 hrs after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24-72 hr
Score:
6.5
Max. score:
8
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hr
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hr
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 72 hr
Irritant / corrosive response data:
The following dermal effects were observed:
After 24 hours, intact skin: haemorrhages and slight or moderate edema.
After 24 hours, abraded skin: haemorrhages and moderate or severe edema.
After 72 hours, intact skin: necrosis and very slight or slight edema.
After 72 hours, abraded skin: necrosis and slight edema.
After three to five weeks all wounds caused by the test compound had healed. On the new skin hair growth was decreased or absent.

Any other information on results incl. tables

Rabbit No.

24 hrs

72 hrs

 

Erythema

Edema

Erythema

Edema

1

4

2

4

2

2

4

3

4

2

3

4

3

4

1

4

4

3

4

2

5

4

3

4

2

6

4

3

4

2

 

 

 

 

 

average

6.8

5.8

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria