Dexpanthenol

Skin irritation / corrosion

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 for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

D-Panthenol

IUPAC Name:

D-Panthenol

Constituent 2

Reference substance name:

Dexpanthenol

EC Number:

201-327-3

EC Name:

Dexpanthenol

Cas Number:

81-13-0

Molecular formula:

C9H19NO4

IUPAC Name:

2,4-dihydroxy-N-(3-hydroxypropyl)-3,3-dimethylbutanamide

Test material form:

liquid: viscous

Test animals

Species:

rabbit

Strain:

other: New Zealand White

Details on test animals or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

no. 90; male

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

no. 91; female

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

no. 92; female

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

no. 90; male

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

no. 91; female

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

no. 92; female

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

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.