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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 9, 1997 to September 12, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to standard guidelines (with deviations) in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period was 72 h instead of 14 d; reversibility not studied, individual animal irritation score at 48 h not reported
Principles of method if other than guideline:
Method: Code of Federal Regulations, Title 16, Section 1500.41
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
2-Propenoic acid, reaction products with pentaerythritol
EC Number:
629-850-6
Cas Number:
1245638-61-2
Molecular formula:
Not available for this UVCB.
IUPAC Name:
2-Propenoic acid, reaction products with pentaerythritol

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd., Margate, Kent, England
- Age at study initiation: 10 - 17 wk
- Weight at study initiation: 2.4 - 3.7 kg
- Housing: Individually in metal cages with perforated floors
- Diet (e.g. ad libitum): STANRAB (P) SQC rabbit diet, ad libitum
- Water (e.g. ad libitum): Drinking water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13.5 - 23 °C
- Humidity (%): 45 - 73 %
- Air changes (per h): 19 air changes/h
- Photoperiod (h dark / h light): 12 h dark/ 12 h artificial light

Test system

Type of coverage:
occlusive
Preparation of test site:
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 h
Observation period:
24 and 72 h
Number of animals:
Six
Details on study design:
TEST SITE
- Area of exposure: 25 mm X 25 mm
- Type of wrap if used: Test material was applied under gauze pads and were covered with 'Elastoplast' elastic adhesive dressing backed with 'Sleek' waterproof strapping for 24 h


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After patch removal, application site were washed with warm water
- Time after start of exposure: 24 h


SCORING SYSTEM:

ERYTHEMA AND ESCHAR FORMATION:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

OEDEMA FORMATION:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 mL): 3
Severe oedema (raised more than 1 mL and extending beyond the area of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h
Score:
3.29
Max. score:
8
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
- At 24 h: Very slight to well-defined erythema with very slight to moderate oedema was seen at intact and abraded sites in all animals.
- At 72 h: Reactions had gradually ameliorated in four animals when very slight to well-defined erythema with or without very slight to slight oedema was seen. Well-defined erythema with slight to moderate oedema was seen in two animals. A necrotic patch or edge was seen at two intact and one atabraded site.
Other effects:
Clinical signs: No signs of toxicity or ill health

Any other information on results incl. tables

Table 1: Irritation score observed at intact and abraded sites after 24 and 72 h

Rabbit

Reaction

24 h

 

72 h

 

 

 

Intact

Abraded

Intact

Abraded

1

Erythema

2

2

1*

1

 

Oedema

3

1

1

0

2

Erythema

2

2

2

2*

 

Oedema

1

3

2

2

3

Erythema

1

1

1

2

 

Oedema

2

2

1

2

4

Erythema

2

2

1

1

 

Oedema

2

3

1

1

5

Erythema

1

2

1

2

 

Oedema

2

2

0

0

6

Erythema

2

2

2*

2

 

Oedema

2

2

3

2

* Necrotic patch or edge

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the primary skin irritation score of the test substance was calculated to be 3.29.
Executive summary:

A study was performed to assess the irritation potential of PETIA to rabbit skin according to a method equivalent or similar to OECD Guideline 404.

0.5 mL was applied to the intact and abraded skin under gauze pads and was covered with 'Elastoplast' elastic adhesive dressing backed with 'Sleek' waterproof strapping for 24 h. After 24 h of exposure, PETIA was removed and the animals were scored for irritation reactions at 24 and 72 h post-application.

Very slight to well-defined erythema with very slight to moderate oedema was observed at 24 h post-application at intact and abraded sites in all animals. At 72 h reading, reactions had gradually ameliorated in four animals when very slight to well-defined erythema with or without very slight to slight oedema were seen. Well-defined erythema with slight to moderate oedema was seen in two animals. A necrotic patch or edge was seen at two intact and one abraded site.

In conclusion, under the conditions of the study, the primary skin irritation score of the substance was calculated to be 3.29.