Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-03-29 to 1993-04-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Post-exposure period of 7 days only

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: SOP of Life Science Laboratory (Japan)
Deviations:
not specified
Principles of method if other than guideline:
Study conducted in accordance with SOP of Life Science Laboratory (Japan)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
no

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. K3135X
- 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: Not specified
- Stability under test conditions: Stable

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

OTHER SPECIFICS:
Purity: 99.9 wt%
Molecular weight: 320.05
Boiling point: 70.8°C
Solubility: Oil soluble

Test animals

Species:
mouse
Strain:
other: ddY
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Japan SLC, Inc.
- Age at study initiation: 4 weeks
- Weight at study initiation: Males: 24.85 - 28.84 grams; Females: 22.74 - 26.58 grams
- Fasting period before study: Food deprivation before and after dosing with the test material
- Housing: 10 animals per cage in stainless steel wire mesh cages
- Diet (e.g. ad libitum): Standard laboratory chow (NMF, Oriental Yeast Co., Ltd.) available ad libitum except before and after dosing with the test material
- Water (e.g. ad libitum): Tap water (from Chihaya-akasuka-mura water supply) available ad libitum from polycarbonate bottles
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 25°C
- Humidity (%): 50 - 70%
- Air changes (per hr): 10 or more air changes per hour
- Photoperiod (hrs dark / hrs light): 8-hour light cycle (09:00 - 17:00)

IN-LIFE DATES: Not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Gum arabic aqueous solution (5% (w/w))
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.1, 1, 10% (w/w)
- Amount of vehicle (if gavage): 0.5 mL/10 grams body weight
- Justification for choice of vehicle: not specified

MAXIMUM DOSE VOLUME APPLIED: 0.5 ml per 10 grams body weight

DOSAGE PREPARATION (if unusual): Test substance was emulsified in 5% (w/w) gum arabic aqueous solution at 0.1, 1, & 10 % (w/w) concentrations when used.
Doses:
50, 500, and 5000 mg/Kg
No. of animals per sex per dose:
10/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Animals were observed frequently on the day of dosing and thereafter once daily for general conditions, behavior and signs of toxicity for 7 days post exposure.
- Necropsy of survivors performed: yes (gross pathological examination)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality or signs of toxicity observed at the highest dose tested.
Mortality:
None observed
Clinical signs:
No abnormal findings in general condition of male or female mice
Gross pathology:
No abnormal findings

Any other information on results incl. tables

Table 2. Experimental Results

Sex

Male

Female

Dose (mg/Kg) and Mortality

5000

0/10

0/10

500

0/10

0/10

50

0/10

0/10

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
GHS Criteria
Conclusions:
Based on the results observed in the study, the acute oral LD50 of 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane was determined to be >5000 mg/Kg in the mouse.
Executive summary:

In a key acute oral toxicity study, the test material (1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane) was administered via oral gavage at single doses of 50, 500, or 5000 mg/Kg to male and female ddY mice (10/sex/dose).

 

Animals were observed frequently on the day of dosing and thereafter once daily for general conditions, behaviour, and signs of toxicity for 7 days post exposure. At the end of the observation period, all surviving animals were sacrificed under ether anaesthesia and necropsied for gross pathological examination.

 

No mortality was observed through the study period. No adverse effects of treatment were observed in animals of either sex exposed to the test material at doses of 50, 500, or 5000 mg/Kg.  

 

Based on the results observed in the study, the acute oral LD50 of 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane was determined to be >5000 mg/Kg in the mouse.