Trisiloxane, 3-ethyl-1,1,1,3,5,5,5-heptamethyl-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 November 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

31 July 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

469-070-1

EC Name:

-

Cas Number:

17861-60-8

Molecular formula:

C9H26O2Si3

IUPAC Name:

4-ethyl-2,2,4,6,6-pentamethyl-3,5-dioxa-2,4,6-trisilaheptane

Test material form:

liquid

Details on test material:

Other name: Baysilone TP 3886

Specific details on test material used for the study:

Density: 828 g/L at 20°C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test animals:
Age on arrival: 9 weeks
Acclimatisation: 5 days
Bodyweights at study start: 1.67-1.931 kg
Housing: individually housed in stainless steel cages
Diet: standard laboratory diet ad libitum
Water: tap water ad libitum

Environmental conditions:
Temperature: 20 +/- 3°C
Humidity: 30-70%
Ventilation: 10 air changes/h
Lighting: 12 h light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: one eye of each animal was treated, the other eye served as a control

Amount / concentration applied:

0.1mL instilled into the conjuctival sac of one eye of each rabbit. Eyes were unwashed post treatment

Duration of treatment / exposure:

72 h

Observation period (in vivo):

The reactions of the eye were evaluated at 1,24,48 and 72 h after instillation

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Animal #1 showed conjuctival redness and chemosis, both grade 1 at the 1 h timepoint

Any other information on results incl. tables

	Cornea			Iris			Conjunctiva redness			Conjunctiva chemosis
Time/animal	26 (#1)	28 (#2)	30 (#3)	26 (#1)	28 (#2)	30 (#3)	26 (#1)	28 (#2)	30 (#3)	26 (#1)	28 (#2)	30 (#3)
1 h	0	0	0	0	0	0	1	0	0	1	0	0
24 h	0	0	0	0	0	0	1	0	0	0	0	0
48 h	0	0	0	0	0	0	0	0	0	0	0	0
72 h	0	0	0	0	0	0	0	0	0	0	0	0
Average score 24-72 h	0	0	0	0	0	0	0.3	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results obtained, it is concluded that heptamethylethyltrisiloxane is slightly irritating to the eye under the conditions of this study, and does not require classification.

Executive summary:

The primary eye irritation potential of heptamethylethyltrisiloxane was evaluated in three male New Zealand White rabbits. A volume of 0.1 ml of the test substance was applied to one eye of each rabbit.The irritation reactions were observed 1, 24, 48 and 72 hours after application.  

In 1 out of 3 rabbits redness (grade 1) and chemosis (grade 1) in the conjunctiva were observed after application. I. Chemosis disappeared 24 hours after application and redness disappeared 48 hours after dosing. .

Based on the results of the study heptamethylethyltrisiloxane is considered to be a slight irritant to the rabbit eye and does not require classification.