2-Propenoic acid, 2-methyl-, 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:

12 to 15 January 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Recent study conducted by a GLP certified laboratory in accordance with a suitable study guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

The storage condition was room temperature, under nitrogen, protected from all lights instead of room temperature as it was indicated in the study plan. This deviation is presumed to have no effect on the health of animals or the integrity of the Study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tripropan-2-ylsilyl 2-methylprop-2-enoate

EC Number:

700-182-8

Cas Number:

134652-60-1

Molecular formula:

C13 H26 O2 Si

IUPAC Name:

Tripropan-2-ylsilyl 2-methylprop-2-enoate

Details on test material:

- Name of test material (as cited in study report): TIS-M
- Lot/batch No.: 9925
- Expiration date of the lot/batch: 2 December 2010
- Storage condition of test material: Under Nitrogen at room temperature, protected from light.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: approx. 15 weeks
- Weight at study initiation: 3665-3890 g
- Housing: Individually housed in AAALC approved metal wire rabbit cages (65x65 cm with height of 45 cm,). Cages were of an open wire
structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: PURINA Base – Lap gr. diet for rabbits ad libitum.
- Water: municipal tap water ad libitum. The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. The quality control analysis is performed once every three months and microbiological assessment is performed monthly by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary). Copies of the relevant Certificates of Analysis are retained in the archives at LAB Research Ltd.
- Acclimation period: 34 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.0-20.5°C
- Humidity (%): 30-64 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 hrs light (between 6am and 6pm).

IN-LIFE DATES: From: 9 December 2009 To: 15 January 2010.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated skin of each animal served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5ml
- Concentration: undiluted
The test item was used undiluted, as a single dose of 0.5 ml of TIS-M, applied to the test area. The untreated skin of each animal served as a control.

Duration of treatment / exposure:

The test item was removed after 4 hours.

Observation period:

The animals were observed for 72 hours after removal of the test item.

Number of animals:

3 male New Zealand White albino rabbits.

Details on study design:

TEST SITE
- Area of exposure: approx 6 cm²
- % coverage:
- Type of wrap if used: plastic

REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: 4 hours

SCORING SYSTEM: 0-4 for both erythema and edema where 0 indicates no erythema/edema and 4 indicates a severe erythema/edema.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24hrs

Score:

0.67

Reversibility:

fully reversible within: 72hrs

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24hrs

Score:

0

Reversibility:

fully reversible within: 72hrs

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48hrs

Score:

0.33

Reversibility:

fully reversible within: 72hrs

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48hrs

Score:

0

Reversibility:

fully reversible within: 72hrs

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72hrs

Score:

0

Reversibility:

fully reversible within: 72hrs

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72hrs

Score:

0

Reversibility:

fully reversible within: 72hrs

Irritant / corrosive response data:

At observation one hour after patch removal, very slight erythema (score 1) was observed in one animal (No:00598).
At observation 24 hours after patch removal, very slight erythema (score 1) was observed in two animals (No:00598, 00508).
At observation 48 hours after patch removal, very slight erythema (score 1) was observed in one animal (No:00508).
At observation 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals.

Other effects:

There was no effect of treatment on body weight and no treatment-related clinical signs noted. No mortality was oserved during the study.

Any other information on results incl. tables

SCORING OF EDEMA FORMATION:

Animal No./ Sex	Body weight (g)
	at the beginning of the study	at the end of the study	1 h	24 h	48 h	72 h
00598/ M	3776	3868	0	0	0	0
00508/M	3665	3783	0	0	0	0
00581/ M	3896	3972	0	0	0	0
TOTAL	-	-	0	0	0	0

M = male d = day h = hour

SCORING OF ERYTHEMA FORMATION:

Animal No./ Sex	Body weight (g)
	at the beginning of the study	at the end of the study	1 h	24 h	48 h	72 h
00598/ M	3776	3868	1	1	0	0
00508/M	3665	3783	0	1	1	0
00581/ M	3896	3972	0	0	0	0
TOTAL	-	-	1	2	1	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The registered substance, according to Directive 2001/59/EC and the UN Globally Harmonised System of Classification and Labelling of Chemicals, does not require classification as a skin irritant.

Executive summary:

A acute skin irritation study of the substance was carried out according to OECD Guideline 404 using New Zealand White Rabbits. The registered substance was applied to the gauze and then placed onto the hairless skin of the rabbit for 4 hours, and after 72hours the substance was determined not to be a skin irritant.