2-Propenoic acid, tris(1-methylethyl)silyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 October 2004 to 16 December 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The restrictions were larger area of test substance application than recommended in guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(area of test substance application was 16 cm2, guideline recommends 6 cm2)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Triisopropylsilyl acrylate

Cas Number:

157859-20-6

Molecular formula:

C12H24O2Si

IUPAC Name:

Triisopropylsilyl acrylate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 11 weeks (male), 12 weeks (females)
- Weight at study initiation: 2141 g (male), 2194-2198 g (females)
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water: Community tap water ad libitum
- Acclimation period: 5 days under laboratory conditions after health examination

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

IN-LIFE DATES: From: 26-Oct-2004 To: 15-Nov-2004

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/animal
- Concentration (if solution): 100%

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

1 male, 2 females

Details on study design:

TEST SITE
- Area of exposure: 16 cm2 on left flank
- % coverage: No data
- Type of wrap if used: Surgical gauze patch covered with a semi-occlusive dressing wrapped around the abdomen and anchored with tape

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

SCORING SYSTEM: Numerical scoring system listed in Commission Directive 2004/73/EC (based on the Draize score system) approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the patch

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

2

Max. score:

8

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Very slight (score 1) to well-defined erythema (score 2) was noted in all animals 1 hour after treatment. Well-defined erythema (score 2) was noted in all animals from the 24- to the 72-hour examination. Very slight (score 1) to well-defined (score 2) erythema was noted in all animals at the 7-day examination and very slight erythema (score 1) persisted in 1 animal up to the 10-day examination. Scaling was noted in 1 animal at the 72-hour examination and in all animals from the 7- to the 14-day examination. No oedema was seen in animal at any timepoint. There were no alterations of the treated skin nor corrosive effects.

Other effects:

No clinical signs of systemic toxicity, mortality or effects on body weight.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

In a 4-hour skin irritation study in rabbits, conducted according to OECD test guideline 404 and in compliance with GLP, undiltued tri(isopropyl)silyl acrylate was a skin irritant.

Executive summary:

Tri(isopropyl)silyl acrylate was tested in an skin irritation test, conducted to OECD test guideline 404 and in compliance with GLP.

Undiluted test material (0.5ml) was applied to the left flank of 3 rabbits for 4 hours and skin was examined for signs of irritation and corrosion 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the patch.

Signs of irritation were seen at the 1-, 24-, 48- and 72-hour, 7- and 10-day time points, but these had disappeared by the 14-day time point. Scaling, evident from the 72-hour time point, persisted to the end of the observation period. No corrosive effects were noted.