1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)pentane

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

02 May 2005 to 27 May 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was not conducted in compliance with GLP regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Materials and methods

Test guideline

Qualifier:

no guideline followed

Guideline:

other: The study was conducted according to a custom protocol.

Deviations:

not applicable

Principles of method if other than guideline:

Four rats were whole body exposed to the test material at 10000 ppm (143.2 mg/L, vapor) for 6 hours a day for 10 days. Animals were observed during exposure and through the remainder of a 14 day observation period.

GLP compliance:

no

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

s-601

IUPAC Name:

s-601

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): s-601
- Substance type: Clear, colorless liquid
- Physical state: Liquid
- Analytical purity: 99.959%
- Purity test date: 10 June 2005
- Lot/batch no.: 41-2601-2240-7

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 202-222 grams
- Fasting period before study: None
- Housing: Individually in metabolism cages
- Diet (e.g. ad libitum): Harlan Teklad LM-485 Mouse/Rat Sterilizable Diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6-23.9
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 02 May 2005 To: 27 May 2005

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 40 liter plexiglass chamber specially designed to observe animal exposure to volatile fluorochemicals. 3.45 ml of the test article was added to the 40 L chamber to generate the exposure atmosphere.
- Method of holding animals in test chamber: No data
- Source and rate of air: no data
- Method of conditioning air: No data
- Temperature, humidity, pressure in air chamber: No data
- Air flow rate: No data
- Air change rate: no data
- Treatment of exhaust air: No data
TEST ATMOSPHERE
- Brief description of analytical method used: No data
- Samples taken from breathing zone: no data

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Animals were exposed to the test atmosphere for 6 hours a day for 10 days.

Frequency of treatment:

Daily for 10 days.

Doses / concentrations

Remarks:

Doses / Concentrations:
0 (control) or 10000 ppm (143.2 mg/L, vapor)
Basis:
nominal conc.

No. of animals per sex per dose:

4 males were exposed to the test article.

Control animals:

yes, concurrent no treatment

Details on study design:

- Dose selection rationale: Based on previous studies
- Rationale for animal assignment (if not random): Random

Positive control:

Not applicable

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Continuously during exposure, daily thereafter
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: Prior to first exposure and daily thereafter
URINALYSIS: Yes
- Time schedule for collection of urine: Study days 4, 7, 12, and 14.
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No data

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

effects observed, treatment-related

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

CLINICAL SIGNS AND MORTALITY: No abnormal clinical signs or mortality were observed during the study.
BODY WEIGHT AND WEIGHT GAIN: All animals gained weight during the study.
URINALYSIS: The concentration of both acid and fluoride metabolites among all test animals was comparable.
GROSS PATHOLOGY: No toxicologically relevant results were noted.

Effect levels

Dose descriptor:

other: 10-day LC50

Effect level:

> 143.2 mg/L air (nominal)

Sex:

male

Basis for effect level:

other: clinical signs; mortality; body weight; urinalysis; gross pathology; organ weights

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Based on the results of the study, the 10-day inhalation LC50 is greater than 10000 ppm (143.2 mg/L, vapor).

Executive summary:

The 10-day inhalation toxicity potential of the test article was determined in male Sprague-Dawley rats. Rats (4/group) were exposed, whole body, to the test material at 0 (control), or 10000 ppm (143.2 mg/L, vapor) for 6 hours a day for 10 days. Clinical observations (continuously during exposure and daily thereafter), body weights (prior to initial exposure, and daily thereafter) were recorded. Urine samples were collected on days 4, 7, 12, and 14 post exposure for urinalysis. Gross necropsy was conducted 14 days after the last exposure. No mortality or abnormal clinical signs were noted during the study period. Concentrations of both acid and fluoride metabolites among all test animals were comparable. All animals gained weight during the study period. No abnormalities were found upon gross necropsy. Based on the results of the study, the 10-day inhalation LC50 is greater than 10000 ppm (143.2 mg/L, vapor).