Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane

Acute Toxicity: inhalation

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

Test material information

Constituent 1

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:

1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane

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- Fasting period before study: No, feeding withdrawn during exposure period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 was provided ad libitum via stainless steel feeders (Tokiwa Kagaku Kikai Co., Ltd.); feeding withdrawn during exposure period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 (LC_L0) of 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane was determined to be >11,100 ppm.