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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:
1990-11-5 to 1990-11-8
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
other: New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Fullinsdorf
- Age at study initiation: male : 14 weeks, females: 15 weeks
- Weight at study initiation: male : 2.2 kg, females: 2.7 - 2.9 kg
- Housing:
- Diet: Pelleted standard Kliba 341, Batch 56/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under test conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+- 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g creme formulation containing 5 % (w/w) Panthenol

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 ( 1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: 6cm²
- Coverage: 3 cm x 3 cm surgical gauze, covered by semi-occlusive dressing

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

SCORING SYSTEM:
OECD/GHS

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
no. 90; male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
no. 91; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
no. 92; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
no. 90; male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
no. 91; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
no. 92; female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
- Clinical signs and viability/mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
- Irritation: The test item showed a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
- Corrosion: No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
- Body weights: With the exception of female no. 92 which showed slight loss of weight during acclimatization the body weight gain of all rabbits was similar.
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No irrtation/corrosive effect occurred on the skin of any animal at measuring interval.
Executive summary:

The test item was investigated for primary skin irritation in a study with rabbits in a 4-hour semi-occlusive application according to OECD guideline 404 and EU method B.4. The test article was applied undiluted in a dose of 0.5 g to the clipped dorsal skin of one male and two female New Zealand White rabbits. The exposure duration was 4 hours under a semi-occlusive wrapping. Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the numerical scoring system according to the guidelines. The skin reaction was assessed at 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.

No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Under the conditions of this experiment, the test item was found to cause a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No corrosive effect occurred on the skin of any animal at measuring interval.