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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

no

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:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 10 or 11 weeks
- Weight at study initiation: 184.1-218.9 g
- Fasting period before study: yes; 16-18 hours prior to dosing
- 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

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: Not Reported

Doses:

175, 550, 1750, 5000 mg/kg

No. of animals per sex per dose:

1 female at 175 mg/kg; 3 females at 550 mg/kg; 4 females at 1750 mg/kg; 2 females at 5000 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at the beginning of fasting, just before dosing (test day 0), once during the first 30 minutes after dosing and 2 more times on the day of dosing, and once each day thereafter.
-Frequency of weighing: on test days –1, 0, 7, and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

1 750 mg/kg bw

95% CL:

871.6 - 4 170

Mortality:

Death occurred in 0/1, 0/3, 2/4, and 2/2 rats dosed at 175, 550, 1750, and 5000 mg/kg, respectively.

Clinical signs:

other: Clinical signs of toxicity were observed in most rats and included wet fur (perineum; underbody; hindquarter; inguen), diarrhoea, ear twitch, hair loss (hindquarters), stained fur/skin (perineum, yellow or brown; chin, brown or yellow; perinasal, brown; a

Gross pathology:

No test substance-related lesions were found in this study. The following gross lesions were nonspecific and not indicative of target organ toxicity: kidneys discoloration and skin stain for one rat at 1750 mg/kg. No other gross lesions were observed.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LD50 (female rats) = 1750 mg/kg

Executive summary:

A single dose of the test substance was administered by oral gavage to 1 fasted female rat at a dose of 175 mg/kg, to 3 fasted female rats at a dose of 550 mg/kg, to 4 fasted female rats at a dose of 1750 mg/kg, and to 2 fasted female rats at a dose of 5000 mg/kg. The rats were dosed one at a time at a minimum of 48-hour intervals. The rats were observed for mortality, body weight effects, and clinical signs for up to 14 days after dosing. All rats were necropsied to detect grossly observable evidence of organ or tissue damage. Death occurred in 0/1, 0/3, 2/4, and 2/2 rats dosed at 175, 550, 1750, and 5000 mg/kg, respectively. Clinical signs of toxicity were observed in most rats and included wet fur, diarrhoea, ear twitch, hair loss, stained fur/skin, lethargy, leaning, slow breathing, high or prostrate posture, ataxia, hyper reactivity, vocalisation, and/or moribundity. Body weight loss of approximately 3% of the fasted weight was observed on day 7 in 1 rat dosed at 1750 mg/kg. No other body weight losses were observed after dosing. No test substance-related gross lesions were found in this study. Under the conditions of this study, the oral LD50 for the test substance was 1750 mg/kg for female rats.