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

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Supplied by: Elevage de Gérome (Quartier Labaste, F-40260 Linxe)
- Acclimitsation period: 5 days
- Weight at beginning of test: 2.49 - 2.72kg
- Age at beginning of test: 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 times per hour
- Housing was illuminated by artificial 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

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye served as control

Amount / concentration applied:

0.1g of the test item was instilled into the conjunctival sac of one eye

Duration of treatment / exposure:

According to the procedures described in the technical guideline, the eyes of the test animal were washed one hour after the test item instillation due to the fact that the solid test item has not been removed from the eye of the test animal by physiological mechanisms.

Observation period (in vivo):

1, 24, 48, 72 hrs following treatment

Number of animals or in vitro replicates:

3 (Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at day 1, two additional animals were treated)

Details on study design:

- 0.1g of the test item was instilled into the conjunctival sac of one eye
- 1hr after the treatment the treated eye was washed due to the fact that the solid test item has not been removed from the eye of the test animal by physiological means
- The other eye remained untreated serving as control
- Intially, a single animal was treated
- After consideration of the ocular responses produced in the first treated animal at day 1, two additional animals were treated

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean value

Time point:

other: 24, 48, 72 hours

Score:

1.3

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean value

Time point:

other: 24, 48, 72 hours

Score:

0.7

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean value

Time point:

other: 24, 48, 72 hours

Score:

0.7

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean value

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean value

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean value

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48, 72 hours

Score:

0.6

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Any other information on results incl. tables

Scoring according to OECD 405

Table 1: Individual data

Animal n°	Time after treatment	CONJUNCTIVAE		IRIS	CORNEA
		CHEMOSIS (A)	REDNESS (C)	LESION (D)	OPACITY (E)
A9873	24 hours	2	2	0	0
	48 hours	1	1	0	0
	72 hours	0	1 (reversible between day 3 and 4)	0	0
TOTAL		3	4	0	0
Mean		1	1.3	0	0
A9877	24 hours	1	1	0	0
	48 hours	0	1	0	0
	72 hours	0	0	0	0
TOTAL		1	2	0	0
Mean		0.3	0.7	0	0
A9884	24 hours	1	1	0	0
	48 hours	0	1	0	0
	72 hours	0	0	0	0
TOTAL		1	2	0	0
Mean		0.3	0.7	0	0
Overall Mean		0.6	0.9	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:

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.

Executive summary:

The test item N-[3 -tris(trimethylsilyloxypropyl]prop-2 -enamide was instilled as supplied, into the eye of 3 New Zealand rabbits at the dose of 0.1 g. The experimental protocol was established on the basis of the official method as defined in theO.E. C.D. guideline n° 405 dated April 24^th, 2002 and the test method B. 5 of the council regulation n° 440/2008.

The ocular reactions observed during the study have been moderate and totally reversible in the three animals:

- at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between day 3 and day 4, associated with a moderate to severe chemosis, noted 1 hour after the test item instillation and totally reversible between day 2 and day 3.

- at the iris level a congestion noted in one animal only at the reading time 1 hour.

In conclusion, 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 the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 6 7/548, 2001/59 and 99/45. No symbol and warning label 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.