3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

EC Number:

211-477-1

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Cas Number:

647-42-7

Molecular formula:

C8H5F13O

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Details on test material:

-Purity: 99.7%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 3000-3591 g
- Housing: Individually in stainless steel, wire mesh cages suspended above cage boards
- Diet (e.g. ad libitum): 125 g rabbit diet daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22ºC
- Humidity (%): 30-70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Artificially illuminated on approximate 12-hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent areas of untreated skin were used for comparison.

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

60 minutes, and 24, 48, and 72 hours after patch removal

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Scapular to lumbar region of the back
- % coverage: approximately 6 cm²
- Type of wrap if used: The test site was covered with a 2-ply gauze pad. The pad was held in place with non-irritating tape. The trunk of each rabbit was wrapped with porous tape. The tape was further secured with waterproof tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently washed with warm water to remove excess test substance and gently patted dry.
- Time after start of exposure: approximately 4 hours


SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Irritant / corrosive response data:

Erythema (score of 1) but no oedema was observed in one rabbit at the 60-minute evaluation. No dermal irritation was observed in this rabbit at 24, 48, or 72 hours. The remaining 2 rabbits exhibited no dermal irritation during the study.

Any other information on results incl. tables

Table 1: Individual Animal Dermal Effects
ERYTHEMA
Rabbit Number	Evaluation after Removal of Test Substance
	0 Minutes	60 Minutes	24 Hours	48 Hours	72 Hours
168^a	0	0	0	0	0
193	---	0	0	0	0
200	---	1	0	0	0
^aInitial rabbit tested
EDEMA
Rabbit Number	Evaluation after Removal of Test Substance
	0 Minutes	60 Minutes	24 Hours	48 Hours	72 Hours
168^a	0	0	0	0	0
193	---	0	0	0	0
200	---	0	0	0	0
^aInitial rabbit tested

Applicant's summary and conclusion

Interpretation of results:

other: Classification not required based on the results of the study.

Remarks:

Criteria used for interpretation of results: other: Directive/67/548/EEC

Conclusions:

The test substance produced erythema, which was reversible by 24 hours when applied to rabbit skin.

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).

Executive summary:

The test substance was applied as a single 0.5 mL dermal dose to the shaved intact skin of a single New Zealand White rabbit. Since no corrosion occurred, 2 additional rabbits were treated. The test substance was applied to a 6 cm² area of skin. The application area was covered with a 2-ply gauze square which was held in place with non-irritating tape and covered with porous tape for a semi-occlusive dressing. The rabbits were exposed to the test substance for 4 hours after which the test substance was removed. Test sites were evaluated and scored by the method of Draize for signs of dermal irritation approximately 60 minutes, and 24, 48, and 72 hours after test substance removal. The rabbit that was initially treated was also examined immediately after test substance removal. Under the conditions of the study, the test substance produced erythema, which was reversible by 24 hours, when applied to rabbit skin.