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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
skin irritation: in vivo - none in vitro test were performed because several in vivo studys are aveailable.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material: Pyridine, alkyl derivs.

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: site 1: shaved; site 2: abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 hours.
Observation period:
24, 48 and 72 hours after initial application.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 x 1 inch
- % coverage: 100 %
- Type of wrap if used: Animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animal was then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours exposure the patches were removed.
- Time after start of exposure: 24 hours.

SCORING SYSTEM:
According to Draize, J.H. (1959) Association of the Food and Drug Officials in the U.S., Austin, Texas. The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.

Erythema and eschar formation Value
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 mm) 3
Severe oedema (raised more than 1 mm 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: 4, 24 and 48 hours
Score:
4.6
Max. score:
8
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 48 and 72 hours
Score:
2.7
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.6
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24, 48 and 72 hours
Score:
2.7
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24, 48 and 72 hours
Score:
2.7
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
4
Reversibility:
no data
Irritant / corrosive response data:
The primary irritation index was 4.6 (4, 24 and 48 hours after treatment). There was no evidence of corrosion. Well-defined erythema with slight to moderate oedema was observed in both sites of all six animals at the 4 hours reading. Well-defined to moderate erythema with slight to moderate oedema was seen in all six animals at the 24 hours reading. Similar observations were mode in all six animals at the 48 and 72 hours reading.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not considered to be corrosive to rabbit skin, although there was evidence of moderate irritation.
Executive summary:

A study was carried out similar or equivalent to EU Method B.4 and OECD Guideline 404 (Acute dermal irritation / corrosion). Adult rabbits (6) were dermally exposed to 0.5 mL of test item for 24 hours introduced to 1 x 1 inches (occluded gauze patch). Following exposure animals were observed for 72 hours. Irritation was scored by the method of Draize (1959).

There was no evidence of corrosion. Well-defined erythema with slight to moderate oedema was observed in both sites of all six animals at the 4 hours reading. Well-defined to moderate erythema with slight to moderate oedema was seen in all six animals at the 24 hours reading. Similar observations were mode in all six animals at the 48 and 72 hours reading.

The test item is not considered to be corrosive to rabbit skin, although there was evidence of moderate irritation.