2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-10-29 to 2012-11-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane

EC Number:

219-154-7

EC Name:

2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane

Cas Number:

2374-14-3

Molecular formula:

C12H21F9O3Si3

IUPAC Name:

2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane

Test material form:

other: solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: ca. 14 weeks old
- Weight at study initiation: >2kg
- Housing: plastic rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


The test item was gently warmed in a water bath at 32 °C for liquid application.

Duration of treatment / exposure:

single instillation,

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
The treated eye was not rinsed 24 hours after the application.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

chemosis 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:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

After the application into the eyes of three female NZW rabbits the test item produced slightly irritant but no corrosive effects.
Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.
Conjunctival redness and discharge were observed in all animals.

Other effects:

Neither mortalities nor significant clinical signs of toxicity were observed.

Any other information on results incl. tables

Table:  Eye Irritation Scores – Animal No. 1

Animal No. 1	Single Data
		Time Post-Application				Average Score (24, 48 and 72 hours)
		1 hour	24 hours	48 hours	72 hours
		T/C	T/C	T/C	T/C
	Conjunctival Redness	1/0	1/0	1/0	0/0	0.67
	Conjunctival Chemosis	0/0	0/0	0/0	0/0	0
	Iris	0/0	0/0	0/0	0/0	0
	Cornea	0/0	0/0	0/0	0/0	0

T =test item,     C = control

Table:  Eye Irritation Scores – Animal No. 2

Animal No. 2	Single Data
		Time Post-Application				Average Score (24, 48 and 72 hours)
		1 hour	24 hours	48 hours	72 hours
		T/C	T/C	T/C	T/C
	Conjunctival Redness	1/0	1/0	1/0	0/0	0.67
	Conjunctival Chemosis	0/0	0/0	0/0	0/0	0
	Iris	0/0	0/0	0/0	0/0	0
	Cornea	0/0	0/0	0/0	0/0	0

T =test item,     C = control

 

Table:  Eye Irritation Scores – Animal No. 3

Animal No. 3	Single Data
		Time Post-Application				Average Score (24, 48 and 72 hours)
		1 hour	24 hours	48 hours	72 hours
		T/C	T/C	T/C	T/C
	Conjunctival Redness	1/0	1/0	1/0	0/0	0.67
	Conjunctival Chemosis	0/0	0/0	0/0	0/0	0
	Iris	0/0	0/0	0/0	0/0	0
	Cornea	0/0	0/0	0/0	0/0	0

T =test item,     C = control

Table:  Clinical Signs of Toxicity

Animal No. 1	Time after Test Item Application	Systemic Findings	Local Findings (apart from findings in Table 3)
	1 hour	nsf	discharge grade 1
	24 hours	nsf	nsf
	48 hours	nsf	nsf
	72 hours	nsf	nsf
Animal No. 2	Time after Test Item Application	Systemic Findings	Local Findings (apart from findings in Table 4)
	1 hour	nsf	discharge grade 2
	24 hours	nsf	discharge grade 1
	48 hours	nsf	nsf
	72 hours	nsf	nsf
Animal No. 3	Time after Test Item Application	Systemic Findings	Local Findings (apart from findings in Table 5)
	1 hour	nsf	discharge grade 2
	24 hours	nsf	nsf
	48 hours	nsf	nsf
	72 hours	nsf	nsf

nsf: no specific findings

Table:  Absolute Body Weights in kg

	Animal No. 1	Animal No. 2	Animal No. 3
Start of Study (weight in kg)	3.1	3.1	3.0
End of Study (weight in kg)	3.2	3.2	3.1

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No irritant effects to rabbit eyes were observed in a study conducted according to current OECD guideline and under GLP.