[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05/Nov/2002 - 08/Nov/2002

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:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether

EC Number:

609-858-6

Cas Number:

406-78-0

Molecular formula:

C4H3F7O

IUPAC Name:

1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether

Test material form:

liquid

Specific details on test material used for the study:

Sponsor's identification: 2,2,2-Trifluoroethyl-1,1,2,2-Tetrafluoroethyl-ether (CAS 406-78-0)
Description: Clear colourless liquid
Batch number: S728010
Date received 09 September 2002
Storage conditions: Room temperature in the dark

Absorption of the test material was not determined. Determination of the pH of the test material was attempted but could not be determined.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three New Zealand White rabbits were supplied by David Percival Ltd, UK. At the start of the study, the animals were 12-20 weeks old and weighed between 2.0 and 3.5kg. After a 5 day acclimitisation period, each animal was given a unique number within the study, which was written with a black indelible marker-pen on the inner surface of the ear and the cage label. The animals were individually housed in suspended metal cages, with free access to mains drinking water and food. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. The temperature and relatively humidity were set to achieve limits of 17°C and 30-70% respectively. The rate of air exchange was at least 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light (06:00 - 18:00) and 12 hours darkness. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5ml

Duration of treatment / exposure:

4 hours

Observation period:

72 Hours

Number of animals:

3

Details on study design:

On the day before the test, each of the 3 rabbits were clipped free of fur from the dorsal/ flank area using veterinary clippers. Only animals with a healthy, intact epidermis by gross observation were selected for the study.
On the day of the test, a suitable test site was selected on the back of each rabbit. 0.5ml of the test substance was introduced under a 2.5cm x 2.5cm cotton gauze patch and placed in position on the shorn skin and secured with surgical adhesive tape. The truck of each rabbit was wrapped in an elasticated corset to prevent interference. The animals were returned to their cages for the duration of the exposure period.
Four hours post application, the corset and patches were removed from each animal and any residual test material was removed by gently swabbing with cotton wool soaked in distilled water. Approx. one following removal of the patches and than at 24, 48 and 72 hours post removal, the test sites were examined for evidence of primary irritation. Any other skin reactions, if present, were also recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

0

Results 8

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

0

Results 9

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

0

Results 10

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

0

Results 11

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

0

Results 12

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

0

Results 13

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

0

Results 14

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

0

Results 15

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

0

Results 16

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

0

Results 17

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

0

Results 18

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

0

Results 19

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

0

Results 20

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

0

Results 21

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

0

Other effects:

There were no other effects seen

Any other information on results incl. tables

The table below summarises the individual scores for erythema/ eschar and oedema:

Skin Reaction	Observation Time	Individual Scores – Rabbit Number and Sex			Total
		62 Male	85 Male	86 Male
Erythema/ Eschar Formation	1 Hour	0	0	0	(0)
	24 Hours	0	0	0	0
	48 Hours	0	0	0	(0)
	72 Hours	0	0	0	0
Oedema Formation	1 Hour	0	0	0	(0)
	24 Hours	0	0	0	0
	48 Hours	0	0	0	(0)
	72 Hours	0	0	0	0
Sum of 24 and 72-hour Readings (S): 0
Primary Irritation Index (S/6): 0/6 = 0.0
Classification: Non-Irritant

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin, according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin, according to the Draize classification scheme. No corrosive effects were noted.