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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, 1981
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
SPF-Quality
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Broekman Institute, Someren / The Netherlands
-Age at start of treatment: approx. 13 weeks
-Body weight at start of treatment: 2515-2882 g
-Identification: ear tag
-Acclimatisation: at least five days under test conditions
-Housing: individual cages with perforated floors equipped with an automatic drinking system (ITL, Bergen / The Netherlands).
-Diet: standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden / The Netherlands), approx. 100 g per day
-Water: tap-water diluted with decalcified water, ad libitum.

ENVIRONMENTAL CONDITIONS
-Temperature: 21 ± 3°C
-Humidity: 30-70 %
-Air changes: 7.5-15 air changes per hr with air-conditioned
-Photoperiod: 12 hrs artificial fluorescent light / 12 hrs dark.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
milli-RO water (water prepared by reverse osmosis)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
-Amount applied: 0.5 g/animal
-Preparation: moistened with milli-RO water (water prepared by reverse osmosis)
Duration of treatment / exposure:
4 hours of application
Observation period:
40 min, 24, 48 and 72 h after the removal of the dressings
Number of animals:
3 females
Details on study design:
TREATMENT
Approximately 24 h before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 cm2 (10 cm * 10 cm).
Prior to test substance administration, the animals were physically examined and the skin found to be intact and normal.
The test substance was applied to the intact skin of the shaved area, using a Metalline patch (2 * 3 cm) mounted to Micropore tape. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
The remaining test substance was removed using a dry tissue and subsequently a tissue moistened with tap-water.

OTHER OBSERVATIONS
-Viability / Mortality, daily.
-Body Weight, once (application day)
-Staining of the treated skin area related to the test substance was described and recorded during each observation.

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 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
IRRITATION
The irritation was reversible within 24 h after exposure in two animals and within 48 h in the third animal.
CORROSION
No corrosive effect was evident on the skin.
Other effects:
TOXICITY SYMPTOMS / MORTALITY
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
COLOURATION
In the area of application black staining of the treated skin by the test substance was observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to CLP Regulation (EC 1272/2008)
Conclusions:
The test substance was found to be non irritant when applied to intact rabbit skin.
Executive summary:

The skin irritation test was performed to rabbit skin according to the OECD guideline 404 (1981). The observed skin irritation consisted of very slight erythema (grade 1) in all animals. The irritation was reversible within 24 hours after exposure in two animals and within 48 hours in the third animal. In the area of application, black staining of the treated skin by test substance was observed. No corrosive effect occurred on the skin and no signs of systemic intoxication were observed in any of the rabbits.