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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12/10/1992 - 19/03/1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether
EC Number:
609-858-6
Cas Number:
406-78-0
Molecular formula:
C4H3F7O
IUPAC Name:
1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether
Test material form:
liquid

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals were 5 weeks old at the time of dosing. Male body weights varied between 104.5 - 120.7g for males and 100.1 - 107.5 for females. No deviations to the environment in which the animals were housed were noted during the course of the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
Animals were fasted overnight prior to the dosing.
Doses:
Preliminary dose range-finder was performed using 20, 100, 500 and 2,000 mg/kg for 7 days to determine experimental dose. As no mortality was observed in any study, the top dose was selected for the final study.
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Both clinical and mortality observations were conducted hourly for 6 hours post-dosing, and twice daily on subsequent days.
Statistics:
Mean values and standard deviations of the body weights were calculated for both sex groups.

Results and discussion

Preliminary study:
No mortality observed.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed in any group.
Clinical signs:
other: Mucous in the stool of animals from the control group was noted between 30 mins to 1 hour after dosing. This ws recorded in both males and females.
Gross pathology:
No abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality or adverse clinical signs were noted in the test group or the control group. Therefore, the medial lethal dose (LD50) for 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether is >2000 mg/kg bw/day.
Executive summary:

An OECD 401 Acute Oral Toxicity study was performed using the test substance 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether using rats. A high dose, 2000 mg/kg bw/day, was selected for the final study, and the control group received a concurrent vehicle control (olive oil). No mortality or adverse effects were noted in the test group or the control group. Some minor effects were noted in the control group, however these were not observed in the test group, and are likely due to the vehicle.

Due to the absence of mortality, the LD50 for the test substance is considered to be >2000 mg/kg bw/day. 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether is not considered to be acutely toxic via the oral route.