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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988/07/26 - 1988/08/09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in accordance to OECD TG

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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)
- Analytical purity: 99.98%

Test animals

Species:

rat

Strain:

other: Crl:CDBR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratory, Kingston, New York
- Age at study initiation: 8 weeks old
- Weight at study initiation: 182 - 260 g
- Housing: individually, in suspended, stainless steel, wire mesh cages
- Diet (e.g. ad libitum): Purine Certified Rodent Chow #5002 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2 °C
- Humidity (%): 50% +/- 10%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 7/26/88 To: 8/9/88

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped intact skin on back, from scapular to lumbar region
- % coverage: test material spread evenly over exposure area, approximately 24 cm^2
- Type of wrap if used: Sterile gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours after exposure

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg for male and female rats (Average Dose (females=0.3 ml), (males= 0.4 ml))

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

The animals were weighed, observed for clinical signs of toxicity and returned to their cages after the exposure. Observations for clinical signs were made approximately 3 hours after dosing and then daily thereafter for 14 days. The animals were weighed on days 1, 6, 9, and 14 following treatment.At the end of the test period, the rats were subject to gross pathological examination. Samples of treated and untreated animals were collected, including: dorsal skin, liver and kidneys.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No rats died within 14 days.

Clinical signs:

other: One male and one female exhibited red nasal or ocular discharges one day after treatment. No dermal irritation was observed.

Gross pathology:

No gross abnormalities were observed in the treated rats sacrificed at the end of the study.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the 24-hr dermal LD50 for 2,2-dichloro-1,1,1-trifluoroethane was greater than 2000 mg/kg-body weight in male and female rats.