Eldew APS-307

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 27 December 2006 and 26 February 2007.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2008

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:

not specified

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): ELDEW APS-307
-Chemical name: Phytosteryl/Decyltetradecyl Myristoyl Methyl Beta-Alaninate
- Substance type: Organic UVCB
- Physical state: Wax
- Analytical purity: 100%
- Lot/batch No.: 609074
- Storage condition of test material: At room temperature, light shielding

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
New Zealand White rabbits were supplied by SUKA FLAT.

- Age at study initiation: Not stated

- Weight at study initiation:
At the start of the study the animals were in the weight range of 3.49 to 3.82 Kg

- Housing: Animals were kept in metal bracket cages.

- Diet (e.g. ad libitum): Solid feed for test animals (RC-4)

- Water (e.g. ad libitum): Tap water with chlorine added

- Acclimation period: Not Stated


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 26℃

- Humidity (%): 30 to 70%

- Air changes (per hr):
All-fresh ventilation of 10 to 15 cycles per hour

- Photoperiod (hrs dark / hrs light):
The lighting was controlled by a time switch to give twelve hours continuous light (07:00 to 19:00) and twelve hours darkness.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: On the day before treatment the hair on both sides of the body of each rabbit was clipped using clippers. Healthy rabbits without island skin were selected.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

- Concentration (if solution):
Not applicable.

VEHICLE
- Amount(s) applied (volume or weight with unit):
Not stated

- Concentration (if solution):
Not applicable.

- Lot/batch no. (if required):
Not given in study report.

Duration of treatment / exposure:

4 hours

Observation period:

Observations of the application site were conducted 1, 24, 48 and 72 hours, and 1 week after removing the patches.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure:
The patches were applied to the left and right sides of each animal’s back.

- % coverage:
Not given in study report.

- Type of wrap if used:
Patches were created by placing cotton lint sized 2.5 cm x 2.5 cm on surgical tape. The cloth was coated with 0.5 g of the test article, and after applying the patch to the skin on the clipped site of the animals, the patch was occlusively covered for 4 hours with stretchable adhesive tape. The patches were applied to the left and right sides of each animal’s back.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None. 4 hours after adhesion, the tape and patches were removed.

- Time after start of exposure:
4 hours.


SCORING SYSTEM:
Observations of the application site were conducted 1, 24, 48 and 72 hours, and 1 week after removing the patches, and skin irritation was assessed in accordance with the following judgment criteria:

Judgment criteria:

A. Erythema and eschar formation
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beef redness) or eschar formation preventing grading of erythema (lesion in deep area)

B. Edema formation
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well defined by definite raising)
3: Moderate edema (raised approximately 1 mm)
4: Severe edema (raised more than 1 mm and extending beyond area of exposure) Observations for changes in scaling, coloration, and corrosion were also conducted.

Risk Assessment:
1) Analysis method:
After calculating scores relating to erythema and edema for each animal based on the judgment criteria, mean values for each reading time were calculated for each test article.

2) Risk assessment:
Based on the above scores, risks were classified as described below in accordance with Annex VI of the European Council Directive Annex.

R35: Causes severe burns
Full thickness destruction of skin tissue occurs as a result of exposure of up to three minutes.

R34: Causes burns
Full thickness destruction of skin tissue occurs as a result of exposure of up to four hours.

R38: Irritating to skin
(1) Cases where one of the following occurs at scores of 24, 48, and 72 hours after removal of the patch and exposure of up to 4 hours, or where one of the following continues for at least 24 hours after exposure.

a. The mean value of the scores for either erythema and eschar formation or edema formation is 2 or more.
b. Erythema and eschar formation or edema formation of a score of 2 or more that is calculated for each animal separately is observed in two or more animals.

(2) Cases where skin irritation continues in two or more animals at the time of final observations (14 days after application of patch).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: No. 00101

Time point:

other: Mean score at 24, 48 & 72 hours

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hrs

Results 2

Irritation parameter:

erythema score

Basis:

animal: No. 00102

Time point:

other: Mean at 24, 48 & 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours & 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal: No. 00103

Time point:

other: mean at 24, 48 & 72 hours

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Basis:

animal: No. 00101

Time point:

other: mean score at 24, 48 & 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No evidence of skin irritation

Results 5

Irritation parameter:

edema score

Basis:

animal: No. 00102

Time point:

other: Mean score at 24, 48 & 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No evidence of skin irritation

Results 6

Irritation parameter:

edema score

Basis:

animal: No. 00103

Time point:

other: Mean score at 24, 48 & 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No evidence of skin irritation

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Other effects:

None.

Any other information on results incl. tables

During the study period, there were no abnormalities in clinical signs observed. During the study period, there were no significant changes in body weight. 24 hours after removal of the patches coated with ELDEW APS-307, very slight erythema was observed in all of the animals. 48 hours and 72 hours after removal of the patches, very slight erythema was observed in 2/3 of the animals. 1 week after removal of the patches, very slight erythema was observed in 1/3 of the animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information to rabbits Criteria used for interpretation of results: OECD GHS

Conclusions:

In accordance with OECD 404 the registration substance is not considered to be an irritant to the skin of rabbits.