3-[3-(1,1,1,3,5,5,5-heptamethyltrisiloxan-3-yl)propoxy]- 2-hydroxypropyl methacrylate and 1-[3-(1,1,1,3,5,5,5-heptamethyltrisiloxan-3-yl)propoxy]-3-hydroxypropan-2-yl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 9, 2002 to September 23, 2002

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:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Elizabethan collars were placed in order to protect the application site after the application of the test article. There were no other deviations from the protocol that might have negatively influenced the reliability of the study.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

10-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-11-yl 2-methylprop-2-enoate; 11-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-10-yl 2-methylprop-2-enoate

EC Number:

700-334-3

Molecular formula:

C17H38O6Si3

IUPAC Name:

10-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-11-yl 2-methylprop-2-enoate; 11-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-10-yl 2-methylprop-2-enoate

Test material form:

other: liquid

Details on test material:

Identification: SiMAA2
Form: Liquid

Test animals

Species:

rabbit

Strain:

other: rabbits bred at Japan SLC, Inc. (Std:JW/CSK)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japan SLC
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.66-2.88 kg
- Housing: Aluminium cage, W40 x D50 x H33 cm ,1 animal per cage.
- Diet : Throughout the quarantine, acclimation, and study periods, 150 g of radiation-sterilized pellet diet (Labo R Stock, Nosan Corporation) per day was fed chlorinated well water ad libitum.
- Water chlorinated well water ad libitum.
- Acclimation period: 7 days
-Floor shavings: not used


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0-27.0 deg C
- Humidity : 30.0-70.0 % RH
- Air changes (per hr): ~13 times/hour
- Photoperiod (hrs dark / hrs light):12 hours/day ( 7am-7pm)


IN-LIFE DATES: From:9th September 2002 To: 23rd September 2002

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The clipped area to the right of the dorsal midline was for the test article and the left of the dorsal midline was for the control,which was treated in the same way as the application of the test article using the gauze patch without the test article

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

5 Days.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Ca 6 cm2
- Type of wrap if used: a gauze patch
(approximately 6 cm2) with 0.5 mL of the test article applied to the skin and adhered with approximately 5 cm × 5 cm non-irritating tape (Blenderm™, 3M). In addition, it was wrapped with adhesive bandage (Silkytex, Alcare Co., Ltd.)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): tissue paper moistened with warm water to remove the test article.
- Time after start of exposure: 4 hours.


SCORING SYSTEM: Draize scale

OBSERVATION OF GENERAL CONDITIONS AND BODYWEIGHT MEASUREMENT:
Animals were observed for general conditions once daily throughout quarantine, acclimation, and test periods. Body weight was measured at receipt, on the day of the application of the test article (just prior to application) and the last day of observation.

SKIN CONDITION:
Immediately before and after the application of the test article, and at 30 minutes, 60 minutes, 24 hours, 48 hours, 72 hours, 4 days and 5 days after removing the gauze patch, test animals were individually observed and scored for signs for erythema and edema based on the skin reaction evaluation criteria described below (see evaluation of skin reaction).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 5 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 5 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No edema recorded ay any observation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No edema recorded ay any observation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No edema recorded ay any observation

Irritant / corrosive response data:

The application site had extremely mild erythema (Score 1 in No. 2102) or clear erythema (Score 2 in Nos. 2101 and 2103) as skin reaction to the SiMAA2 application in all cases from the observation at 30 minutes after removing the gauze patch. Erythema was observed at observation 60 minutes, 24 hours, and 48 hours after on the application site in all the cases; however, it decreased over time and disappeared at 72 hours after in one case (No. 2102) and by 5 days after in the other two cases (Nos. 2101 and 2103). There was no crust or edema formation at any application site in any animal throughout the observation period, and
corrosivity of SiMAA2 to the skin was not detected in rabbits.

Other effects:

Although the test animal No. 2103 had laceration and bleeding on the lips, which was probably caused by the Elizabethan collar, there were no other abnormalities in general condition seen in any of the test animals throughout the study period.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

There was no crust or edema formation at any application site in any animal throughout the observation period, and corrosivity of SiMAA2 to the skin was not detected in rabbits.

Executive summary:

The test article was liquid; therefore, it was used as it was without dilution.

Animals were restrained with a restraint system with collar, and then a gauze patch (approximately 6 cm2) with 0.5 mL of the test article applied to the skin and adhered with approximately 5 cm × 5 cm non-irritating tape (Blenderm™, 3M). In addition, it was wrapped with adhesive bandage (Silkytex, Alcare Co., Ltd.), and a Elizabethan collar (Natsume Seisakusho Co., Ltd.) was placed on the neck before returning to the animals to the cages. The exposure time was for 4 hours. The gauze patch was removed after the exposure, and the application site was cleaned with tissue paper moistened with warm water to remove the test article. The clipped area to the right of the dorsal midline was for the test article and the left of the dorsal midline was for the control, which was treated in the same way as the application of the test article using the gauze patch without the test article.

Immediately before and after the application of the test article, and at 30 minutes, 60 minutes, 24 hours, 48 hours, 72 hours, 4 days and 5 days after removing the gauze patch, - 3 - test animals were individually observed and scored for signs for erythema and edema based on the skin reaction evaluation criteria

Although the test animal No. 2103 had laceration and bleeding on the lips, which was probably caused by the Elizabethan collar, there were no other abnormalities in general condition seen in any of the test animals throughout the study period.

The application site had extremely mild erythema (Score 1 in No. 2102) or clear erythema (Score 2 in Nos. 2101 and 2103) as skin reaction to the SiMAA2 application in all cases from the observation at 30 minutes after removing the gauze patch. Erythema was observed at observation 60 minutes, 24 hours, and 48 hours after on the application site in all the cases; however, it decreased over time and disappeared at 72 hours after in one case (No. 2102) and by 5 days after in the other two cases (Nos. 2101 and 2103). There was no crust or edema formation at any application site in any animal throughout the observation period, and corrosivity of SiMAA2 to the skin was not detected in rabbits.