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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:
25 September 2008 - 20 October 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2004
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TETRABBIT Kft. 2173 Kartal, Csaszar ut 135, HUNGARY
- Age at study initiation: 11 weeks
- Weight at study initiation: 3376-3404 g
- Housing: single, in metal cages
- Diet: P. Strengthened Female Hare (Herba) diet ad libitum
- Water: tap water from watering bottles ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
- From: 30 September 2008
- To: 14 October 2008

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
initial test: 3 minutes, 1 hour and 4 hours
confirmatory test: 4 hours
Observation period:
In the initial test, the degree of irritation was evaluated at 3 minutes, 1 and 4 hours after the treatment, then at 1, 24, 48, 72 hours and one and two weeks following the patch removal.
In the confirmatory test, the degree of irritation was evaluated at 1, 24, 48 and 72 hours following the patch removal.
Number of animals:
3, males only
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm2 area of intact skin
- Type of wrap: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: After each treatment period (initial test: 3 min., 1 hour and 4 hours, confirmatory test: 4 hours) the rest of the test item was removed using body temperature water.

SCORING SYSTEM: Draize, 1959

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
6320/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
2549/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
6325/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
6320/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
2549/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
6325/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
In the initial test any irritant response was found in animal No.: 6320/M after 3 minutes exposition. Very slight erythema (score 1) was observed in this animal after 1 hour exposition, as well as well defined erythema (score 2) occurred in same animal after 4 hours exposition. Since corrosive effect was not observed in the initial test, two additional animals were treated with one patch, for an exposure period of four hours.
In the confirmatory test, one hour after the patch removal well defined erythema (score 2) was observed in animal No.: 6320/M. In the others (No.: 2549/M, 6325/M) very slight erythema (score 1) appeared.
24 hours after the patch removal all animals became free of symptom.
48 hours after the patch removal all animals were symptom-free.
72 hours after the treatment the confirmatory study was terminated, since there were no primary irritation symptoms. The observation of the first animal continued for two weeks.
1 week after the patch removal the animal of initial test was symptom-free.
2 weeks after the patch removal the initial test was terminated, since there were no any primary irritation symptoms.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is considered to be not irritating to skin under the test conditions chosen.
Executive summary:

The acute skin irritation study of the test item was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 404, 2002).

The study consisted of initial and confirmatory test. The initial test was needed, because the substance was suspected to have corrosion potential on the basis of pH value (1.76). In initial test, three patches were applied sequentially to the hairless skin of one experimental animal. The dose was 0.5 g per patches.

In confirmatory test, the test item was administered in pure state, in a single dose of 0.5 g to the hairless skin of all experimental rabbits. The untreated skin of each animal served as control.

After each patch removal, the rest of the test item was removed with water of body temperature.

The irritation symptoms were examined at 1, 24, 48 and 72 hours then one and two weeks after the patch removal in first animal and at 1, 24, 48 and 72 hours after the patch removal in second and third animals. For the initial test, in the first animal the test site was also examined after the treatment (3 min., 1 and 4 hours exposition time).

In the initial test very slight erythema was observed in first animal after 1 hour exposition. Well defined erythema appeared in same animal after 4 hours exposition. Since corrosive effect was not found in the initial test, two additional animals were treated with one patch, for an exposure period of four hours.

One hour after the patch removal, very slight erythema occurred in two animals. Well defined erythema was observed in first animal.

24 hours after the patch removal all animals were symptom-free.

72 hours after the treatment the confirmatory study was terminated, since there were no primary irritation symptoms. The observation of the first animal continued for two weeks.

2 weeks after the patch removal the initial test was terminated, since there were no any primary irritation symptoms.

The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00, 0.00 and 0.00 respectively.

During the study the behaviour and general state of animals were normal.

There were no notable body weight changes during the contact and observation period.