2,2-dichloro-1,1,1-trifluoroethane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6/14/88 - 6/28/88

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in accordance to OECD guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dichloro-1,1,1-trifluoroethane

EC Number:

206-190-3

EC Name:

2,2-dichloro-1,1,1-trifluoroethane

Cas Number:

306-83-2

Molecular formula:

C2HCl2F3

IUPAC Name:

2,2-dichloro-1,1,1-trifluoroethane

Constituent 2

Reference substance name:

Ethane, 2,2-dichloro-1,1,1-trifluoro- -

IUPAC Name:

Ethane, 2,2-dichloro-1,1,1-trifluoro- -

Details on test material:

- Name of test material (as cited in study report): Ethane, 2,2-dichloro-1,1,1-trifluoro- (HCFC-123).
- Physical state: clear, liquid.
- Analytical purity: approximately 99.98% .
- Stability under test conditions: The test material was assumed to be stable under the conditions of administration.
- Storage condition of test material: The test material was received on 4/12/88 in a pressurized cylinder. A sample of the material was removed from the cylinder and stored in a refrigerator. Just prior to treatment, the sample was removed from the refrigerator and was stored in ice during dosing.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hare Marland, Hewitt, New Jersey
- Weight at study initiation: 2316-2617 grams
- Housing: singly in suspended, stainless steel, wire-mesh cages.
- Diet (e.g. ad libitum): Purina Certified High Fiber Rabbit Chow #5325 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20C+/-2C
- Humidity (%): 50% +/- 10%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

IN-LIFE Phase: From: 6/14/88 To: 6/28/88

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL aliquot of HCFC-123

Duration of treatment / exposure:

single dose: material was in place for 4 hours before removal

Observation period:

6/14/88-6/28/88 (14 days, termination on day 15)

Number of animals:

4 males and 2 females

Details on study design:

TEST SITE
- Area of exposure: from the scapular to the lumbar region of the back.
- Type of wrap if used: gauze secured by tape, then wrapped in rubber sheeting (approximately 8: x 18") for 4 hours.

EXPOSURE CONDITIONS
- Each rabbit was placed into a stock which was fitted with a piece of rubber sheeting. The rabbits remained in the stock throughout the exposure period and during that time did not have access to food or water.

POSITIVE CONTROL
- Sodium lauryl sulfate was used as a positive control with simultaneous exposure with Ethane, 2,2-dichloro-1,1,1-trifluoro test material.
- 0.5 ml aliquot, moistened with distilled water, was applied to a separate test site on the same animals.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently washed with warm water and gently wiped dry.
- Time after start of exposure: 4 hours.

SCORING SYSTEM: Draize (see attached Table I: Draize Scoring system)

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4, 24, 48, 72

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Irritant / corrosive response data:

-HCFC-123 produced no dermal irritation in any of the treated rabbits throughout the study (See attached Table (2)).
-Primary irritation scores for the postive control material ranged from 5.0 to 6.0. It produced mild or moderate erythema with slight to moderate edema by 4 hours after treatment. By 48 hours, severe erythema with slight or mild edema was observed.

Other effects:

Other dermal effects of the positive control substance included necrosis, superficial necrosis, thickening, raw areas or fissuring of the skin, eschar and epidermal scaling. Severe erythema and some dermal effects were still evident at study termination (day 15).

Any other information on results incl. tables

See attached result tables (2), (3), and (4)

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, dermal exposure to 2,2-dichloro-1,1,1-trifluoroethane in rabbits did not result in any irritation.