Reaction mass of 3-[3-(9-butyl-1,1,3,3,5,5,7,7,9,9-decamethylpentasiloxanyl)propoxy]-2-hydroxypropyl 2methylprop-2-enoate and 1-[3-(9-butyl-1,1,3,3,5,5,7,7,9,9-decamethylpentasiloxanyl)propoxy]-3-hydroxypropan-2-yl 2-methylprop-2-enoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 8 2006 to October 23 2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

(2R)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2R)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate; (2S)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2S)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate

EC Number:

700-043-1

Molecular formula:

C24H56O8Si5

IUPAC Name:

(2R)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2R)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate; (2S)-1-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-2-yl 2-methylprop-2-enoate; (2S)-2-hydroxy-8,8,10,10,12,12,14,14,16,16-decamethyl-4,9,11,13,15-pentaoxa-8,10,12,14,16-pentasilaicosan-1-yl 2-methylprop-2-enoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Compound A
-Lot numbeer: T060620
- Appearance: clear to mild yellowish transparent liquid

Test animals

Species:

rabbit

Strain:

other: Kbs:JW

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kitayama Labes Co., Ltd
- Age at study initiation: 11 weeks
- Weight at study initiation: Average 2.20 kg
- Housing:Rabbit cage 690 x 490 x 380 (mm). Floor space 3380 cm2
- Diet: Solid feed for rabbits and guinea pigs. Approximately 120-130g of feed was fed with limit using a suspending feeder made of aluminium attached to the cage.
- Water : ad libitum, from the automatic water supply system.
- Acclimation period: 7 days after receipt.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0-22.7
- Humidity (%): 52.0-60.1
- Air changes (per hr): Over 7 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours (lighted hours: 8:00am-8:00pm

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: Clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A half mL of the test article was evenly applied to lint cloth.

Duration of treatment / exposure:

4 hours.

Observation period:

72 hours after the removal of the test article.

Number of animals:

3.

Details on study design:

TEST SITE
Area of exposure: Approx 6 cm2 (1-inch-square, approx 2.5 cm x 2.5 cm).

Type of wrap if used: Test article applied to a lint cloth. The lint cloth was wrapped with plastic membrane and then with adhesive-elastic dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the application period, the adhesive-elastic dressing was immediately removed and the applied site of the test article was washed clean with distilled water.
- Time after start of exposure: 4 hours.

Observation of general condition

Animals were observed before the application, 1, 24, 48, and 72 hours after the
removal of the test article.
Body weight

Animals were weighed using the electronic scale before the application and 72 hours
after the removal of the test article.
Skin observation

Skin was scored based on the criteria described below for erythema and incrustation
and development of edema at 1, 24, 48, and 72 hours after the removal of the test
article. The applied site was assessed not to have any problem before the application
of the test article.

Evaluation

The test article was evaluated for corrosivity and irritability based on the average
scores for erythema and incrustation and development of edema at 24, 48, and 72
hours after the removal of the test article according to the Globally Harmonized
System of Classification and Labeling of Chemicals.

SCORING SYSTEM:
The rating criteria for skin reactions
Rating criteria Scores
1) Erythema and incrustation
No erythema ·················································································································0 points
Very mild erythema (barely visible) ·············································································1 point
Clear erythema ··············································································································2 points
Moderate to severe erythema ························································································3 points
Dark red erythema to slight incrustation (damage to deeper area) ·······························4 points
2) Development of edema
No edema ······················································································································0 points
Very mild edema (barely visible)··················································································1 point
Mild edema (clear edge recognized by obvious swelling) ············································2 points
Moderate edema (swelling to approximately 1 mm)·····················································3 points
Severe edema (swelling of 1 mm and spreading beyond the exposed area) ···············4 points

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 00101

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: No effects seen at any time point

Results 2

Irritation parameter:

erythema score

Basis:

animal: 00102

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: No effects seen at any time point

Results 3

Irritation parameter:

erythema score

Basis:

animal: 00103

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: No effects seen at any time point

Results 4

Irritation parameter:

edema score

Basis:

animal: 00101

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: No effects seen at any time point

Results 5

Irritation parameter:

edema score

Basis:

animal: 00102

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: No effects seen at any time point

Results 6

Irritation parameter:

edema score

Basis:

animal: 00103

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: No effects seen at any time point

Irritant / corrosive response data:

There was no erythema and incrustation and development of edema observed in skin at 1, 24, 48, and 72 hours after the removal of the test article. Therefore, the average score for erythema and incrustation and development of edema in each animal was 0.0.

Other effects:

None.

Any other information on results incl. tables

No histopathological examination was performed since there was no skin reaction.

There was no abnormality found in general condition in animals before the application, 1, 24, 48, and 72 hours after the removal of the test article.

There was no weight loss observed in weight changes between the application and 72 hours after the removal of the test article.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Compound A was applied for 4 hours on the skin of rabbits in order to evaluate the skin irritability. No erythema and incrustation and development of edema were observed at any time at skin evaluation 1, 24, 48, and 72 hours after the removal of the test article.
As a result of skin evaluation based on the Globally Harmonized System of Classification and Labeling of Chemicals, Compound A was considered to be classified as non-corrosive and non-irritant.

Executive summary:

In a primary dermal irritation conducted to OECD Guideline 404, three rabbits were dermally exposed to 0.5ml of the undiluted test material for four hours.

After 4 hours of skin application, no erythema, incrustation, or developments of edema were observed on the skin at 1, 24, 48, and 72 hours after the removal of the test article. In addition, there was no abnormality seen in general condition or weight change. Based on the above results, Compound A was considered to be classified as non-corrosive and non-irritant.