Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study, which was an Annex VII requirement at the time
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November - December 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Lekutherm Beschleuniger KU 6519 Neu
Specific details on test material used for the study:
Batch 3078183

Test animals

Species:
rabbit
Strain:
other: young albino rabbits
Details on test animals and environmental conditions:
TEST ANIMALS
- Species: Young albino rabbits without morbid signs
- Source: Dr. Zimmerman, Schweizer Hof, Untergröningen, Germany
- Weight at study initiation: 3472 g, 2773 g and 2906 g
- Housing: Individually in wire grating cages (area 2450 cm2, height 42 cm) without bedding
- Diet: Raiffeisen-Ringfutter, Kaninchen Trockenfutter 52/P, Raiffeinsen Kraftfutterwerk Kehl, ad libitum
- Water: Community tap water from Karlsruhe, free access for the animals by daily changing of the watering-bottles
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 30 - 70 %
- Light-dark-rythm: 12 : 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: The shaved area next to the exposure area was employed such as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per animal

VEHICLE
- test substance moistened with a small amount of water
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
2 male, 1 female rabbit
Details on study design:
The test substance moistened with a small amount of water was dermally applied in a songle dose of 0.5 g / per animal onto a shaved area of 3 x 5 cm2 of the dorso-lumbar region of three albino rabbits. The region treated was protected with an occlusive patch. After the end of the exposure period of 4 hours the bandage was removed and residual test substance was removed by gently washing with water.
In the following observation period of 7 days mortality, toxicological symptoms, behaviour, body weight and skin reactions were reported. The shaved area next to the exposure area was employed such as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour after bandage removal
Score:
1.3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour after bandage removal
Score:
1.3
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
The test substance produced skin lesions in the form of erythemata and oedemata. The maximum grade of these lesions was 2. All effects observed turned out to be reversible.
Other effects:
Visible toxicological signs could not be observed; none of the animals died during the observation period.

Any other information on results incl. tables

Acute Dermal Irritation/Corrosion, Evaluation of the skin reaction.

Mean value of all animals.

Test substance Control
Time after application Erythema Oedema Erythema Oedema
1 hour after bandage removal 1.3 1.3 0 0
day 1 1 1 0 0
day 2 1 0.7 0 0
day 3 0.7 0.3 0 0
day 4 - - - -
day 5 0.3 0.3 0 0
day 6 0 0 0 0
day 7 0 0 0 0

Skin reaction control:

The shaved area close to the exposure area was employed such as control. The control area did not show any pathological skin reaction. According to table 1 of OECD-Guideline 404 at all times of evaluation the value was classified as 0.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The study was performed according to the OECD Guideline 404 with no deviations and according to the good laboratory practice principles, it is considered to be of the highest quality (reliability Klimisch 1). The criteria of validity of the test system are fulfilled. The mean grades of skin reactions at 24, 48 and 72 h after patch removal were lower than the value classified as irritant by the European regulation (EC) No. 1272/2008, amending regulation EC no. 1907/2006 (REACh). When applied to the skin, the test article may therefore be considered to be non-irritant. The test material did produce skin lesions in the form of erythemata and oedemata on the intact skin of rabbits. None of these lesions had a grade above 2 and all lesions were fully reversible latest within 6 days. The test substance is considered to be not irritating to the skin.
Executive summary:

The skin irritation potential of the test substance was investigated in rabbits (Dr. B. Grunert, 1994, according to TG OECD 404). The test substance was applied to the skin of rabbit (skin shaved, substance moistened with water, 0.5 g substance / animal applied) for 4 hours under occlusive conditions. The study was performed according to the OECD Guideline 404 with no deviations and according to the good laboratory practice principles, it is considered to be of the highest quality (reliability Klimisch 1). The criteria of validity of the test system are fulfilled. After this period the skin was evaluated 60 min and daily for 7 days after patch removal. The test substance produced skin lesions in the form of erythemata and oedemata. The mean grades of skin reactions were lower than the value classified as irritant by the European regulation (EC) No. 1272/2008, amending regulation EC no. 1907/2006 (REACh). When applied to the skin, the test article may therefore be considered to be non- irritant.