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Diss Factsheets

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

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).