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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 January 2005 to 16 March 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Guideline-conform study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
1,1,1,3,3-pentafluoro-3-methoxy-2-(trifluoromethyl)-propane
IUPAC Name:
1,1,1,3,3-pentafluoro-3-methoxy-2-(trifluoromethyl)-propane
Constituent 2
Reference substance name:
Propane, 1, 1, 1, 3, 3- pentafluoro- 3- methoxy- 2- (trifluoromethyl) –
IUPAC Name:
Propane, 1, 1, 1, 3, 3- pentafluoro- 3- methoxy- 2- (trifluoromethyl) –
Constituent 3
Chemical structure
Reference substance name:
2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane
EC Number:
609-534-4
Cas Number:
382-26-3
Molecular formula:
C5H4F8O
IUPAC Name:
2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane
Details on test material:
- Name of test material (as cited in study report): Octafluoroisobutyl methyl ether
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: >86%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: n.a.
- Purity test date: not reported
- Lot/batch No.: 161 - (20/01/04)
- Expiration date of the lot/batch: 2006
- Stability under test conditions: Stable under storage condition
- Storage condition of test material: in the refrigerator (range 5 +- 3°C), light protected

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
300
Doses:
2000 mg/kg, 300 mg/kg, 50 mg/kg
No. of animals per sex per dose:
3 at dose of 2000 mg/kg
3 at dose of 300 mg/kg
6 at dose of 50 mg/kg
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - < 300 mg/kg bw
Based on:
act. ingr.

Any other information on results incl. tables

Mortality

All three 2000mg/kg treated animals died within five and half hours after treatment. All three 300 mg/kg treated animals were founded dead on test day 2.

Clinical signs

Sightly ruffled fur was observed in all 2000 mg/kg treated animals from the 30 -minute reading to the 1- or 2 -hour reading and sligh to moderate ruffled fur persistent in one animal up to the 5 -hour reading. Hunched posture was noted in all three animlas of this group at the 30 -minute reading and persistent up to the 1 or 3 -hour observation in two animals. Slight to marked sedation was observed in all animals from the 30 -minute reading to the 1 -, 2 - or 5 -hour reading, respectively. Deep respiration was observed in one animal at the 3 -hour reading and was still noted at the 5 -hour examination. Ventral recumbency was seen in two animals one hour before death occurred.

In all animals treated with 300 mg/kg slightly ruffled fur and hunched posture was noted from the 1 -hour to the 5 -hour examination. Feces containing mucus was noted in two animals of the second-treated group at the 2 -hour or 3 -hour reading and persistent up to the 5 -hour observation in one animal. Hypothermia by hand-touch at the 5 -hour examination was noted in the same animals. All three animals in this group appeared slightly sedated at the 5 -hour observation.

The animals treated with 50mg/kg bw did not show any clinical signs.

Macroscopic findings

In all three 2000 mg/kg bw treated animals, liquid contents were found in the stomach, duodenum, jejunum and ileum and additionally in the caecum of two animals at the unscheduled necropsy after spontaneous death. Stomach containing liquid and distended with gas was observed at the unscheduled necropsy of all three 300mg/kg bw treated animals.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The median lethal dose of Octafluoroisobutyl methyl ether after single oral administration to female rats, observed over a period of 14 days is:
50 mg / kg bw < LD50 (female rats) < 300 mg /kg bw.
Executive summary:

The study has been conducted in accordance with OECD 423 guideline Acute Oral toxicity - Acute Toxic Class Method.

Four groups, each of three female HanBri: WIST (SPF) rats, were treated with Octafluoroisobutyl Methyl Ether by oral gavage administration at a dosage of 2000 mg/kg, 300 mg/kg, 50 mg/kg body weight.

The following animals were treated and percentage of mortality was observed:

3 females treated at 2000 mg/kg

100 %

3 females treated at 300 mg/kg

100 %

6 females treated at 50 mg/kg

0 %

 

All three 2000 mg/kg treated animals died within five and a half hours after treatment. All three 300 mg/kg treated animals were found dead on test day 2.

Sightly ruffled fur was observed in all 2000 mg/kg treated animals from the 30 -minute reading to the 1- or 2 -hour reading and sligh to moderate ruffled fur persistent in one animal up to the 5 -hour reading. Hunched posture was noted in all three animlas of this group at the 30 -minute reading and persistent up to the 1 or 3 -hour observation in two animals. Slight to marked sedation was observed in all animals from the 30 -minute reading to the 1 -, 2 - or 5 -hour reading, respectively. Deep respiration was observed in one animal at the 3 -hour reading and was still noted at the 5 -hour examination. Ventral recumbency was seen in two animals one hour before death occurred.

In all animals treated with 300 mg/kg slightly ruffled fur and hunched posture was noted from the 1 -hour to the 5 -hour examination. Feces containing mucus was noted in two animals of the second-treated group at the 2 -hour or 3 -hour reading and persistent up to the 5 -hour observation in one animal. Hypothermia by hand-touch at the 5 -hour examination was noted in the same animals. All three animals in this group appeared slightly sedated at the 5 -hour observation.

The animals treated with 50mg/kg bw did not show any clinical signs.

The body weight of the animals was within the range commonly recorded for this strain and age.

In all three 2000 mg/kg bw trated animals, liquid contents were found in the stomach, duodenum, jejunum and ileum and additionally in the caecum of two animals at the unscheduled necropsy after spontaneous death. Stomach containing liquid and distended with gas was observed at the unscheduled necropsy of all three 300mg/kg bw treated animals.

In conclusion the median lethal dose of Octafluoroisobutyl methyl ether after single oral administration to female rats, observed over a period of 14 days is:

50 mg / kg bw < LD50 (female rats) < 300 mg /kg bw.

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