Reaction mass of fatty acids, montan-wax, 1-methyl-1,3- propanediyl esters and fatty acids, montan-wax, ethylene esters and fatty

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

5 Jul 2005 to 14 Jul 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 404, EU B.4)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

In compliance with the Swiss legislation an Good Laboratory Practice

Test material

Test material information

Constituent 1

Reference substance name:

Montan waxes, type CaV 102

IUPAC Name:

Montan waxes, type CaV 102

Details on test material:

- Name of test material (as cited in study report): Licomont CaV 102 Fine Grain
- Substance type: Slightly yellow powder
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature (range of 20 ± 5 °C), light protected.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories France, L'Arbresle, France
- Age at study initiation: 14 to 15 weeks (male), 12 to 13 weeks (females)
- Housing: Individually in stainless steel cages
- Diet (ad libitum): standard Provimi Kliba 3418 rabbit maintenance
diet (batch no. 22/05) (Provimi Kliba AG, Kaiseraugst, Switzerland)
- Water (ad libitum): Community tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- 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:

shaved

Vehicle:

water

Remarks:

test substance moistened with water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g in 0.5 ml water

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 of mixed sex

Details on study design:

TEST SITE
- Area of exposure: 4 x 4 cm
- % coverage: 100%
- Type of wrap if used: semi-occlusive dressing

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

SCORING SYSTEM: numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004, approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test item

EVALUATION: To evaluate the irritation of the test item the mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythenna/eschar grades and for oedema grades, separately. An animal is positive when the mean score is 2 or greater. The test is positive for irritation when at least 2 animals are positive for the same endpoint (erythema/eschar or oedema).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: scores of individual animals: 0.33, 0.0, 0.0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed at any time point

Remarks on result:

other: scores of individual animals: 0.0, 0.0, 0.0

Irritant / corrosive response data:

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.33, 0.00 and 0.00, respectively and the mean oedema score was 0.00 for all three animals.
Very slight erythema was noted in two animals at the 1-hour examination and persisted up to the 24-hour examination in one of these animals.
No abnormal findings were observed an the treated skin of any animal 48 hours after treatment for all animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test item was not irritating to the skin of rabbits

Executive summary:

The primary skin irritation potential of the test item (Licomont CaV 102 Fine Grain) was investigated according to OECD test guideline no. 404. The test item was applied by topical semiocclusive 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 application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as erythema. These effects were reversible and were no longer evident 48 hours after treatment for all animals. 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.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.33, 0.00 and 0.00, respectively and the mean oedema score was 0.00 for all three animals.

Thus, the test item did not induce significant or irreversible damage to the skin