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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
Study period:
November 27, 1997 - July 03, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch number: 971108
Description: white crystalline solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River GmbH, Sulzfeld
- Age at study initiation: no data available
- Weight at study initiation:
animal #1: 2623 g (at the start) ; 2677g (at conclusion of the test)
animal #2: 2613g (at the start); 2665g (at conclusion of the test)
animal l#3: 2863g (at the start), 2954g (at conclusion of the test)
- Housing: Altromin Type S8/15, granulated soft wood bedding, Batch 181297
- Diet (e.g. ad libitum): Altromin 2123, standard diet for rabbits, Batch 220198/1404
- Water (e.g. ad libitum): tap water (municipal supply), Makrolon bottles, daily change
- Acclimation period: 6 weeks before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22°C
- Humidity (%): 35-45%
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): artificial light is set to give a cycle of 12 hours light and 12 hours dark, light from 6.30 a.m. - 6.30 p.m.

IN-LIFE DATES: From: To:

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test article
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit): the gauze patch with the test article on it was moistened with distilled water and then applied
Duration of treatment / exposure:
The administration was performed on January 15, 1998, 8.39 - 8.41 a.m.
Exposition period: 4 hours
Observation period:
Animals were examined for sings of erythema and oedema and the response scored at 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: 4x5 cm on the left and on the right side of the spine (one area was used as control)
- % coverage: 2.5x3.5 cm (gauze patch, two layers)
- Type of wrap if used:overed with aluminium foil (3x4 cm) which was held in contact with the skin by occlusvie dressing (Lohmann GmbH & Co. , Neuwied)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application area was washed with water.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Grading of skin reaction:
Erythema and Eschar formation value
No erythema .............................................................................0
Very slight erytheina (barely perceptible) ........................... 1
Well defined erythema .............................................................2
Moderate to severe erythema................................................ 3
Severe erythema (beet redness) to eschar formation
preventing grading of erythema............................................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 millimetre) .............. 3
Severe oedema (raised more than 1 millimetre
and extending beyond area of exposure)......................................4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
4
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
see "results and discussions"
Other effects:
The control skin areas of the animals didn`t show any alterations at any observation time.
The treated skin areas showed only a slight erythema one hour after patch removal in two animals.
Other signs of irritation were not observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The application of 0.5g of the test item to shaved dorsal area of trunk of albino rabbits caused only a slight erythema on hour after patch removal in two animals. No systemic toxic effects were observed.

Executive summary:

The acute dermal irritation/corrosion of the test item was tested in three albino rabbits.

The test article was applied in a single dose of 0.5 g to a shaved dorsal area of trunk and covered with agauze patch and aluminium foil which was held in contact with the skin by an occlusive dressing. Exposure duration was 4 hours. Thereafter residual substance was removed using water.

Animals were examined for mortality, clinical signs and signs of irritation response 60 minutes, 24, 48, 72 hours after patch removal.

Only a slight erythema was observed one hour after patch removal in two animals. No animal died or showed clinical signs in the course of testing.