Registration Dossier

Administrative data

Description of key information

Skin: EU Method B.4, rabbit. No irritation. Reliability = 1

Eye: EU Method B.5, rabbit. Reversible mild irritation. Reliability = 1

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2.5-2.9 kg
- Housing: metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: animals were acclimated; period of time not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per animal

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL per animal
Duration of treatment / exposure:
4 hours
Observation period:
30 minutes after removal of the patches and on Days 2, 3, and 4
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 10 cm square
- % coverage: not reported
- Type of wrap if used: "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water
- Time after start of exposure: 4 hours

SCORING SYSTEM:The Draize Dermal Irritation Scoring System was used.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no signs of irritation at any time point.
Interpretation of results:
GHS criteria not met
Conclusions:
No irritation was observed in any animal throughout the study.
Executive summary:

The test substance was evaluated for acute skin irritation potential in 3 young adult New Zealand white rabbits. A dose of 0.5 g moistened with 0.5 mL water was applied to the intact skin site under a semiocclusive dressing for 4 hours. The application site was then washed and observed for signs of irritation 30 minutes after removal of the test substance, and subsequently on Days 2, 3, and 4. There were no signs of irritation at any time point.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The test substance did not produce skin irritation in the rabbit; eye irritation in the rabbit was reversible.

Justification for classification or non-classification

The test substance did not produce skin irritation and eye irritation was mild and reversible. The substance does not need to be classified for irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.