(S,S)-1,1,1,2,2,3,4,5,5,5-decafluoropentane;reaction mass of: (R,R)-1,1,1,2,2,3,4,5,5,5-decafluoropentane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

2 males were dosed (instead of the required 5/sex); 5000 mg/kg bw was used instead of 2000 mg/kg bw; no pathology was performed.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

420-640-8

EC Name:

-

Cas Number:

138495-42-8

Molecular formula:

C5H2F10

IUPAC Name:

(3R,4R)-1,1,1,2,2,3,4,5,5,5-decafluoropentane; (3S,4S)-1,1,1,2,2,3,4,5,5,5-decafluoropentane

Details on test material:

- Purity: 99.9%

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: 2525 and 2502 g
- Fasting period before study: No
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): 125 g rabbit chow daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Approximately 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1°C
- Humidity (%): 50±10%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 190 cm2
- % coverage: 190 cm2 is equal to approximately 10% of the total body surface area of rabbits in the 2-3 kg body weight range
- Type of wrap if used: The test substance was covered with a 2-ply gauze patch. The rabbit was wrapped with successive layers of plastic film, stretch gauze bandage, and elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess test substance was washed from the animals' backs with warm water and the skin was dried with a paper towel.
- Time after start of exposure: approximately 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
- Concentration (if solution): undiluted

Duration of exposure:

24 hours

Doses:

5000 mg/kg

No. of animals per sex per dose:

2 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made daily throughout the study. Approximately 1 hour after test substance removal, the rabbits were observed for clinical signs of toxicity and dermal irritation. Observations for clinical signs and other dermal effects were made daily for 14 days after treatment (excluding weekends).
- Frequency of weighing: On the day of dosing and on days 1, 7, and 14 following treatment
- Necropsy of survivors performed: No

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: Adverse Effects: No clinical signs of toxicity; slight dermal irritation in 1 rabbit, but not the other.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

other: at worst, slightly toxic

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

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

LD50 > 5000 mg/kg

Executive summary:

The test substance was applied to the shaved, intact skin of 2 male New Zealand White rabbits at a dosage of 5000 mg/kg. The application site was occluded for approximately 24 hours after which the test substance was removed. The rabbits were observed for clinical signs of toxicity and dermal effects for 14 days following removal of the test substance (weekends excluded). No deaths occurred, and no clinical signs of toxicity were observed in either rabbit. The test substance produced slight erythema 1 and 2 days after application in one rabbit. No irritation was observed in the second rabbit. Under the conditions of this test, the ALD was >5000 mg/kg of body weight.