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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:
2006-06-07 to 2006-09-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study according to OECD test guideline 404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

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
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg
- Age at study initiation: approx. 11 month
- Weight at study initiation: 2.6 — 2.7 kg
- Housing: caged individually in PPO cages (floor area: 2576 sq. cm)
- Diet: pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe, was available ad libitum
- Water: free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: > 30 - < 70 %
- Air changes: 10/hour
- Photoperiod: cycle of 12 hours light and 12 hours darkness. Light was on from 6 am to 6 pm.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch with adhesive Gothaplast tape

REMOVAL OF TEST SUBSTANCE
- Washing: mild soap and lukewarm water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(3266)
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(3268)
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(3269)
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(3266)
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(3268)
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(3269)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
During an initial test using one female albino rabbit a sequential application (exposure time 3 min., 1 h. and 4 h.) was carried out on one site of the left back area each. The skin was examined for signs of irritation straight after as well as 1 h., 24 h., 48 h. and 72 h. after the termination of exposure. Since the animal did not show any sign of skin irritation within the observation period of 72 hours it was decided to carry out a confirmatory test with two additional animals in order to allow a categorization of the test item based on the classification criteria.
Two female albino rabbits were exposed to the test item at one skin site on the back during the confirmatory test. After 4-hour exposure time the test item was removed and the skin was examined 1 h., 24 h., 48 h. and 72 h. after the termination of exposure as well as on day 7 and 14. In contrast to the initial test partially uncertain skin reactions were revealed at these animals. A well defined formation of erythema and oedema was only shown on the peripheral area, whereas the treated skin in the centre of the real test area did not show an erythema at first.
On account of these contradictory and uncertain findings it was not possible to assess clearly the effects caused by the substance. Therefore, the confirmatory test was repeated.

Applicant's summary and conclusion

Interpretation of results:
other: not classified (GHS); classified Xi, R38 (DSD)
Remarks:
Criteria used for interpretation of results: EU