Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

Skin irritation/corrosion

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 May 1992 to 22 May 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD Guideline-conform study conducted under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

EC Number:

500-537-5

EC Name:

Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

Cas Number:

161075-00-9

Molecular formula:

R-O(C3F6O)m-R with R= - CF3, - C2F5, -CF2H

IUPAC Name:

1,1,1,2,3,3-hexafluoro-2,3-bis(1,1,2,2,2-pentafluoroethoxy)propane; 1,1,1,2,3,3-hexafluoro-2-(1,1,2,2,2-pentafluoroethoxy)-3-(trifluoromethoxy)propane; 1,1,1,2,3,3-hexafluoro-3-(1,1,2,2,2-pentafluoroethoxy)-2-(trifluoromethoxy)propane; 1,1,1,2,3,3-hexafluoro-3-{[1,1,1,2,3,3-hexafluoro-3-(trifluoromethoxy)propan-2-yl]oxy}-2-(trifluoromethoxy)propane; 1,1,1,3,3,4,6,6,7,9,9,10,12,12,12-pentadecafluoro-4,7,10-tris(trifluoromethyl)-2,5,8,11-tetraoxadodecane; 1-(difluoromethoxy)-1,1,2,3,3,3-hexafluoro-2-(1,1,2,2,2-pentafluoroethoxy)propane; 2,2,3,5,5,6-hexafluoro-3,6-bis(trifluoromethyl)-1,4-dioxane; 2-(difluoromethoxy)-1,1,1,2,3,3-hexafluoro-3-(1,1,2,2,2-pentafluoroethoxy)propane

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Galden HT 70
- Substance type: Pure substance
- Physical state: liquid
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: G 30
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: far from heating sources (volatile)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: livestock farming
- Age at study initiation: about 2-3 months
- Weight at study initiation: about 2.5 - 3 kg
- Housing: individual caging in air-conditioned rooms. Metal cages measuring 62 x 47.5 x 38 cm.
- Diet (e.g. ad libitum): Certificated pelleted diet, supplied with vitamins and trace elements. Available ad libitum
- Water (e.g. ad libitum): from municipal water main system, filtered and disrtibuted ad libitum.
- Acclimation period: about 2 months. Animals were observed daily to ascertain their fitness for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +-2
- Humidity (%): 50 % +- 15
- Air changes (per hr): about 15/ hour
- Photoperiod (hrs dark / hrs light): 12 hour cicle (7 a.m.-7 p.m.)

IN-LIFE DATES: From: To: not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml /animal
- Concentration (if solution): not applicable

VEHICLE
Test material was applied as supplied by the sponsor.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 females

Details on study design:

Firstly one rabbit was used and three treatment sites were prepared. On the first site the test article was applied for an exposure period of 3 minutes. No serious gross skin reactions are noted and the test article was applied for an exposure period of 1 hour on the second site. The application area was covered with a gauze patch loosely held in contact with the skin by an impermeable, non.irritant, hypoallergenic tape. No serious gross reactions are observed after the one-hour exposure period and the test article was appliedfor an exposure period of 4 hours on the third skin site. This area was covered with a gauze patch as above. The test was completed using two additional animals with a 4 hour exposure period.

TEST SITE
- Area of exposure: about 6 cm2
- % coverage: occlusive
- Type of wrap if used: gauze patch loosely held in contact with the skin by an impermeable, non.irritant, hypoallergenic tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: the skin reaction was scored according to the following scale:

VALUE ERYTHEMA AND ESCHAR FORMATION
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formatioon (injuries in deoth)


VALUE EDEMA FORMATION
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well defined by definite raising)
3 Moderate edema (raised approximately 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 60 min

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

same result in all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 60 min

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

same result in all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No dermal modifications were observed in any animal.

Other effects:

No animals died.
No clinical signs or behavioral alterations were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions adopted, GALDEN LMW is to be considered "NON IRRITANT" for the skin when administered by dermal route to rabbits.

Executive summary:

The purpose of the study was to evaluate the acute dermal irritation and/or corrosive effects on skin following the application of the test article GALDEN LMW.

The test method was in accordance with the EEC Guidelines B.4 and with OECD guidelines 404 (Paris 1981, and subsequent revisions).

Three New Zeland White female rabbits were treated with a single application of 0.5 ml of the test article.

Approximately 24 hours before the test, fur was clipped from the trunk of the animals. Care was taken not to abrade the skin. Only animals with intact skin were used.

The test article was applied to a small area (approximately 6 cm2) of skin. Firstly one rabbit was used and three treatment sites of the skin were prepared. On the first site the test article was applied for an exposure period of 3 minutes. No serious gross skin reactions were noted and the test article was applied for an exposure period of 1 hour on the second site. The application area was covered with a gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape. No serious gross reaction were observed after the one-hour exposure period and the test article was applied for an exposure period of 4 hours on the third skin site. This area was covered with a gauze patch as above. The test was completed using two additional animals with a 4 hour exposure period. At the end of the exposure period, residual test substance was removed, without altering the existing response of the integrity of the epidermis.

Neither deaths occurred as a result of treatment, nor clinical signs or behavioral alterations were observed untoward.

At the application site, no dermal reactions were detected in any rabbit.

The test article GALDEN LMW when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered "NON IRRITANT" for the skin.