N-(3-{1,1,1,5,5,5-hexamethyl-3-[(trimethylsilyl)oxy]trisiloxan-3-yl}propyl)prop-2-enamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-10-26 to 2010-01-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well performed GLP study according to OECD technical guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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:

yes (incl. QA statement)

Remarks:

Certificate is attached to full study report.

Test material

Test material information

Constituent 1

Reference substance name:

N-(3-{1,1,1,5,5,5-hexamethyl-3-[(trimethylsilyl)oxy]trisiloxan-3-yl}propyl)prop-2-enamide

EC Number:

700-253-3

Cas Number:

115258-10-1

Molecular formula:

C15H37NO4Si4

IUPAC Name:

N-(3-{1,1,1,5,5,5-hexamethyl-3-[(trimethylsilyl)oxy]trisiloxan-3-yl}propyl)prop-2-enamide

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Supplied by: Elevage de Gérome (Quartier Labaste, F-40260 Linxe)
- Acclimitsation period: 5 days
- Weight at beginning of test: 2.23 - 2.75kg
- Sex: male
- Age at beginning of test: 11 or 12 weeks
- Each animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Temperature: 17-23°C
- Relative humidity: 30-70%
- Air exchange rate was approximately 15 timer per hour
- Housing was illuminated by aritificial light in a 12hrs lighting / 12hrs darkness cycle

- Drinking water: tap-water from public distribution system, ad libitum
- Foodstuff: SDS-C15, ad libitum
- Microbial and chemical analyses of the water were carried out once every six months by the IPL, Santé, Environment Durables - Atlantique

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: On the opposite flank, an untreated area served as the control

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

4hrs

Observation period:

1, 24, 48, 72hrs after patch removal

Number of animals:

Three animals (initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated accordingly).

Details on study design:

- 24hrs prior to testing, the rabbit's back and flanks were shorn using electric clippers
- An area of 6cm2 was shorn
- No tissue destruction was observed after a treatment during 3min and 1hr
- The test item was applied as supplied at a dose of 0.5g on an undamaged skin area of one flank of each animal
- Patch was secured in position with a strip of surgical adhesive tape under a semiocclusive dressing
- After removal of the patch, the treated area was rinsed with distilled water
- On the opposite flank an untreated area served as control
- Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were tested accordingly

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animals 1-3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: See Table 1

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animals 1-3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: See Table 1

Any other information on results incl. tables

Scoring according to OECD 404

Table 1: Individual data

OBSERVATIONS		INDIVIDUAL DATA						Total of individual data
Skin reactions	Observation time	Animal n°	Weight (kg)	Animal n°	Weight (kg)	Animal n°	Weight (kg)
		A9849	Start : 2.23	A9853	Start : 2.42	A9854	Start : 2.64
			End : 2.34		End : 2.55		End : 2.75
Erythema and eschar	24 hours	0		0		0		0
	48 hours	0		0		0		0
	72 hours	0		0		0		0
Total		0		0		0
Mean		0.0		0.0		0.0
Oedema	24 hours	0		0		0		0
	48 hours	0		0		0		0
	72 hours	0		0		0		0
Total		0		0		0
Mean		0.0		0.0		0.0
CLASSIFICATION in accordance with 67/548/EEC		According to the calculated means, the item is not be classified.
CLASSIFICATION in accordance with 1272/2008/EC		According to the calculated means, the item is not be classified.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No cutaneous reactions (erythema and oedema) were observed, on the treated area, whatever the examination times (i.e. 1, 24, 48 and 72 hours after the patch removal) were.

Executive summary:

The test item N-[3 -tris(trimethylsilyloxypropyl]prop-2 -enamide was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established from the O.E.C.D. guideline n° 404 dated April24^th, 2002 and the test method B.4 of the Council regulation No 440/2008.

No cutaneous reactions (erythema and oedema) were observed, on the treated area, whatever the examination times (ie 1, 24, 48 and 72 hours after the patch removal) were.

The results obtained, under these experimental conditions, enable to conclude that the test item N-[3 -tris(trimethylsilyloxypropyl]prop-2 -enamide is not to be classified according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.

In accordance with the Globally Harmonized System (Regulation (EC) No 1272/2008), the test item is not to be classified. No signal word and hazard statement are required.