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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:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

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: 2.2-2.7 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 °C
- 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:
14 days
Number of animals:
3
Details on study design:
Due to animal welfare reasons only one animal was initially treated with three test patches. These were successively removed: after 3 minutes, after 1 hour and the third was allowed to remain 4 hours, in each case if no serious skin reactions were observed. Completion of the test was then carried out using 2 additional animals, exposed for 4 hours.

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
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 of the rabbits. Care was taken to avoid abrading the skin. Only animals with healthy and intact skin were used. 0.5 mL of the pure liquid test substance was applied to the skin of the animal under a gauze patch. The treated skin area was approximately 2.5 cm by 2.5 cm in size. The patch was placed on the dorso-lateral areas of the trunk of each animal and was held in place with non-irritating 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.

REMOVAL OF TEST SUBSTANCE
After the exposure period the dressing and patch were removed.
- Washing (if done): The exposed skin area was carefully washed with water.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #3
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score: 1
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Other effects:
Animal 2, day 7 after patch removal: desquamation.
There were no relevant systemic intolerance reactions.

Applicant's summary and conclusion

Conclusions:




Classification: not irritating
Executive summary:

An Acute Dermal Irritation/Corrosion test was conducted with the substance according to OECD TG 404. Under the conditions of the test the substance showed no up to very slight dermal irritation (Mean score of time points 24, 48, and 72 h: 0.3 for erythema, 0 for oedema). There were no relevant systemic intolerance reactions.