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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

Remarks:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Remarks:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EEC Methods for the Determination of Toxicity Method B.3 Directive 92/69/EEC (1992)

Deviations:

no

Remarks:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males, approximately 9 weeks; females, approximately 10 weeks
- Weight at study initiation: males, 283.1 g avg; females, 230.3 g avg.
- Fasting period before study: no
- Housing: singly in stainless steel, wire-mesh cages suspended above cage boards
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26 °C
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back from scapular to lumbar region
- % coverage: approximately 37 square centimetres (approximately 10% of total body surface area)
- Type of wrap if used: 2-ply gauze patch, stretch gauze bandage, and self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water and skin was dried
- Time after start of exposure: approximately 24 hours after treatment

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg body weight

Duration of exposure:

24 hours

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily throughout the study
- Frequency of weighing: on test days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: dermal responses daily, excluding weekends

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

1/5 male and 1/5 female

Clinical signs:

other: The cageboard below two female rats’ cages was stained bright yellow on the day after application. No other clinical signs of systemic toxicity were observed. One male rat exhibited red-stained fur/skin on the chin, face, and mouth on the day after applic

Gross pathology:

No gross lesions were present in the rats at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Not required Criteria used for interpretation of results: other: Directive 67/548/EEC

Conclusions:

LD50 > 5000 mg/kg
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).

Executive summary:

A single dose of the test substance was applied to the shaved, intact skin of 5 male and 5 female rats at a dose of 5000 mg/kg of body weight. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for up to 14 days following application. The rats were necropsied to detect grossly observable evidence of organ or tissue damage. One male and 1 female rat were found dead the day after application of the test substance (during the exposure period). No other deaths occurred. The cageboard below two female rats’ cages was stained bright yellow on the day after application. No other clinical signs of systemic toxicity were observed. Body weight loss of approximately 4% of the day 0 weight was observed in 1 female rat on day 7. This rat gained weight by day 14. No other body weight losses were observed. No dermal irritation was observed. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the skin absorption LD50 for the test substance was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours. In accordance with the provisions of Directive 67/548/EEC, classification by the dermal route is not required based on the results of this study.