[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-03-06 - 2007-07-17 (experimental interval)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Study according to OECD / EU-Guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Nomcort HKG

IUPAC Name:

Nomcort HKG

Test material form:

solid: pellets

Details on test material:

- Name of test material (as cited in study report): Nomcort HKG
- Substance type: organic
- Physical state: solid
- Analytical purity: 100%
- Lot/batch No.: 5-11-B
- Expiration date of the lot/batch: 29-APR-2007
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: at room temperature, light protected

Specific details on test material used for the study:

- Name of test material (as cited in study report): Nomcort HKG
- Substance type: organic
- Physical state: solid
- Analytical purity: 100%
- Lot/batch No.: 5-11-B
- Expiration date of the lot/batch: 29-APR-2007
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: at room temperature, light protected

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan NetherlandsBV, Kreuzelweg 53, NL-5961 NM Horst, The Netherlands
- Age at study initiation: 13 weeks (male), 14 weeks (female)
- Weight at study initiation: 1975 - 2231 g
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

Test item moistened with purified water.

Controls:

not required

Amount / concentration applied:

500 mg Test Item in 0.5 ml water

Duration of treatment / exposure:

4

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm * 2.5 cm
- Type of wrap if used: gauze, then semi-occlusive dressing

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

SCORING SYSTEM: as cited in Guidelines

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Skin Irritation Scores - individual values
Animal 1 (male)
Erythma (1 hour) 0
Erythma (24 hour) 0
Erythma (48 hour) 0
Erythma (72 hour) 0
Edema (1 hour) 0
Edema (24 hour) 0
Edema (48 hour) 0
Edema (72 hour) 0

Animal 2 (female)
Erythma (1 hour) 0
Erythma (24 hour) 0
Erythma (48 hour) 0
Erythma (72 hour) 0
Edema (1 hour) 0
Edema (24 hour) 0
Edema (48 hour) 0
Edema (72 hour) 0

Animal 3 (female)
Erythma (1 hour) 0
Erythma (24 hour) 0
Erythma (48 hour) 0
Erythma (72 hour) 0
Edema (1 hour) 0
Edema (24 hour) 0
Edema (48 hour) 0
Edema (72 hour) 0

Other effects:

no other effects reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, Nomcort HKG is considered to be "not irritating".

Executive summary:

The primary skin irritation potential of Nomcort HKG was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

The test item did not licit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.