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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:
Feb 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
Principles of method if other than guideline:
Testing strategy comprised a stepwise approach including the evaluation of existing human and/or animal data showing effects on the skin or mucous membranes, the performance of a SAR evaluation for skin corrosion/irritation, measurement of pH value, the evaluation of data on systemic toxicity vial the dermal route and the performance of a validated in vitro test for skin corrosion (Human 3D Epidermal Skin Model) before in vivo testing for skin irritation/corrosion in rabbits.
GLP compliance:
yes (incl. certificate)

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Crl:KBL(NZW)BR
- Sex: female
- Source: Charles River, 88353 Kißleg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 3.2-3.3 kg
- Housing: individually in cage units Metall/Noryl by EBECO
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The surrounding untreated skin served as control
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
Until changes had completely subsided, however for not more than 14 days after application.
Number of animals:
3
Details on study design:
Due to a possible irritant potential of the test substance, in the first step only one animal was used and three test patches were applied successively to this animal, as described above. The first patch was removed after three minutes. As no serious skin reactions were observed, the second patch was applied and removed after one hour. At this stage the observations indicated that with respect to animal welfare the exposure can be allowed to extend to four hours, therefore the third patch was applied and removed after four hours and the responses were graded one hour later. The test was completed using two additional animals, exposed for four hours.

TEST SITE
On the day before the test, the fur was shorn on the right and left side from the dorso-lateral area of the trunk of each rabbits. 0.5 mL of the pure liquid test substance was applied to the skin of the animal under a gauze patch. The patch was placed on the dorso-lateral areas of the trunk of each animal and was held in place with non-irritant tape for the duration of the exposure period. Thus, access by the animal to the patch and resultant ingestion of the test substance was prevented.
- Area of exposure: approximately 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed skin area was carefully washed with water without altering the existing response, or the integrity of the epidermis.
- Time after start of exposure: after 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(redness and eschar formation)
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
The control areas did not show any abnormal findings.
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Executive summary:

A skin irritation/corrosion test according to OECD 404 was conducted with the test substance. No signs of irritation could be observed at all after 24, 48 and 72 hours postexposure-time (all scored zero). There were no systemic intolerance reactions.