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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-10-21 to 2012-10-26

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 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2734-14-3

IUPAC Name:

2734-14-3

Constituent 2

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 animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: 21-22 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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: left side on the dorsal area
- Type of wrap if used: the test item was applied to a gauze patch, which was applied to the skin and held in place with non-irritating tape. The patch was fixed with semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema 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:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Initial test in animal no. 1: no signs of irritation were seen immediately after the patch removal. Examination of the test site 1 hour after patch removal revealed erythema grade 1 which was fully reversible within 24 hours after the patch removal. No irritant or corrosive effects were observed on the intact skin of the two further female rabbits (strain NZW) of the main test after a contact time of 4 hours.

Any other information on results incl. tables

Under the conditions of the present study, the single dermal application of the test item F-D3 to three rabbits at a dose of 0.5 g showed irritant but no corrosive effects in animal no.1 which were fully reversible within 24 hours. Neither mortalities nor significant clinical signs of toxicity were observed.

Table: Dermal Irritation Evaluation

Animal No.	Application Site	Irritation (hours after patch removal)
		1 hour		24 hours		48 hours		72 hours
		T	C	T	C	T	C	T	C
1	Erythema	1	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0
2	Erythema	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0
3	Erythema	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0

T = test item;       C = control;        0 – 3 = grade

Table: Individual Data

Individual Systemic and Local Findings - Animal No. 1
Time after Patch Removal	Systemic Findings	Specific Local Findings (apart from erythema/oedema)	Comments
1 hour	nsf	nsf	-
24 hours	nsf	nsf	-
48 hours	nsf	nsf	-
72 hours	nsf	nsf	-
Individual Systemic and Local Findings - Animal No. 2
Time after Patch Removal	Systemic Findings	Specific Local Findings (apart from erythema/oedema)	Comments
1 hour	nsf	nsf	-
24 hours	nsf	nsf	-
48 hours	nsf	nsf	-
72 hours	nsf	nsf	-
Individual Systemic and Local Findings - Animal No. 3
Time after Patch Removal	Systemic Findings	Specific Local Findings (apart from erythema/oedema)	Comments
1 hour	nsf	nsf	-
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)	4.4	4.2	3.1
End of Study (weight in kg)	4.4	4.2	3.2

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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