Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-12-10 to 1994-02-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane
EC Number:
206-581-9
EC Name:
Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane
Cas Number:
355-37-3
Molecular formula:
C6HF13
IUPAC Name:
Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Asahi Glass Co., Ltd. (Japan); Batch no. 31001
- Expiration date of the lot/batch: Not specified
- Purity test date: Not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, dark place
- Stability under test conditions: Not specified

FORM AS APPLIED IN THE TEST (if different from that of starting material): Liquid

OTHER SPECIFICS:

Purity: 99.939%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Crj:CD, SPF strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan, Inc.
- Age at study initiation: 5 weeks old
- Weight at study initiation: Males: 161 - 179 grams; Females: 134 - 146 grams
- Fasting period before study: No, feeding withdrawn during exposure period
- Housing: 2-3 rats of same sex in polycarbonate cages (Tokiwa Kagaku Kikai Co., Ltd.) with hard wood chip bedding (Beta-chip, Charles River Japan Inc.). Cages were placed on a steel rack (four-tiered; Tokiwa Kagaku Kikai Co., Ltd.)
- Diet (e.g. ad libitum): Pellet diet MF: Oriental Yeast Co., Ltd.) was provided ad libitum via stainless steel feeders (Tokiwa Kagaku Kikai Co., Ltd.); feeding withdrawn during exposure period
- Water (e.g. ad libitum): Tap water (filtered and irradiated by UV) was supplied ad libitum via polycarbonate bottles (700 mL; Tokiwa Kagaku Kikai Co., Ltd.)
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 25°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 12 air changes per hour (all fresh air supply)
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light (07:00 - 19:00)

IN-LIFE DATES: Not specified

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: pyramidal shaped exposure chamber (800 mm W x 800 mm D x 450 mm H)
- Exposure chamber volume: 510 L
- Method of holding animals in test chamber: Male and female rats placed individually in a wire mesh cage (150 mm W x 120 mm D x 130 mm H) located in the inhalation chamber
- Source and rate of air: bubbling compressed air (7 L/min; pressure = 1.5 Kg/cm2G); blowing compressed air (2 L/min; pressure = 1.0 Kg/cm2G)
- Treatment of exhaust air: Gas was supplied to the inhalation chamber in one-pass way from the top, and was exhausted from the bottom (105 L/min, ventilation rate: 12.4 times/hr)
- Temperature, humidity, pressure in air chamber: Temperature and humidity measures every hour (Toyama's temperature and humidity measuring apparatus, Toyama Keiki Co.)

TEST ATMOSPHERE
- Brief description of analytical method used: From the inhalation chamber, 1 mL of gas was collected with an airtight syringe (2 mL) 0.5, 2.0, and 3.5 hours after the commencement of exposure and then analyzed using GC.
- Samples taken from breathing zone: not specified

VEHICLE
- Composition of vehicle (if applicable): compressed air bubbled or blown
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
10000.0 ppm (mean exposure concentration was 11100.0 ppm)
No. of animals per sex per dose:
5/sex/concentration
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical Signs: From the commencement of exposure to 2 hours after the end of the exposure, observations of all rats on clinical signs were made every hour, therafter once a day for 14 days.
Body weights: All rats were weighed just before 3, 7, & 14 days post exposure.
- Necropsy of survivors performed: yes; At the end of the 14 day observation period, animals were euthanized by severing the abdominal aorta under thiopental sodium anesthesia and then subjected to necropsy.
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LCLo
Effect level:
> 11 100 ppm
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: No mortality or adverse signs of clinical toxicity observed
Mortality:
No mortality was observed through the study period
Clinical signs:
other:
Body weight:
To the end of the observation period, normal increase of body weight was observed in all male and female rats.
Gross pathology:
Necropsy did not reveal any abnormal findings.

Any other information on results incl. tables

Table 1. Exposure Concentration in the Chamber

Intended Concentration

(ppm)

Measured Concentration (ppm) by time (hours)

Mean Concentration

(ppm)

0.5

2.0

3.5

10000

11000

11400

11000

11,100

 

Table 2. Environment in the Chamber

 

Time after commencement of exposure (hours)

 

0

1

2

3

4

Temperature (°C)

23

24

24

24

24

Relative Humidity (%)

67

60

60

60

60

O2Concentration (%)

20.4

20.4

20.4

20.4

20.4

 

Table 3. Body Weight Results (grams)

Sex

Animal Number

Day After Exposure

0

3

7

14

 

 

 

Male

1

177

205

245

313

2

179

209

246

319

3

165

195

227

289

4

161

194

216

275

5

162

193

233

297

Mean

169

197.0

233

299

S.D.

8.6

10.0

12.6

17.9

 

 

 

 

Female

1

137

157

178

213

2

137

152

168

204

3

146

164

185

210

4

140

155

171

197

5

131

144

164

201

Mean

138

154

173

205

S.D.

5.4

7.3

8.3

6.5

 

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
GHS Criteria
Conclusions:
Based on the results observed in this study, the minimal lethal concentration (LCL0) of 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane was determined to be >11,100 ppm.
Executive summary:

In a key acute inhalation toxicity study, the test material (1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane) was administered via whole body inhalation (vapour) to male and female SD (Crj:CD, SPF) rats (5/ex/concentration) at a concentration of 10000 ppm (measured concentration was 11,100 ppm) for a period of 4 hours.

 

From the commencement of exposure to 2 hours after the end of the exposure, all rats were observed for clinical signs every hour, and once a day thereafter for a period of 14 days. All rats were weighed just before 3, 7, & 14 days post exposure. At the end of the 14-day observation period, animals were euthanized by severing the abdominal aorta under thiopental sodium anaesthesia and then subjected to necropsy.

 

No mortality was observed through the study period and no clinical signs of test-material related toxicity were observed in animals of either sex. Normal increase in body weight was observed in all male and female rats to the end of the observation period and necropsy did not reveal any abnormal findings.

 

Based on the results observed in this study, the minimal lethal concentration (LCL0) of 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane was determined to be >11,100 ppm.