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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 January 2005 to 1 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 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
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
- Storage condition of test material: in the refrigerator (range of 5 +-3°C), light protected
- Other: density = 1.496 g/mL

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.

Any other information on results incl. tables

Mortality

No deaths occurred during the study.

Clinical / Local signs

Exophtlamus was noted in one male animal from test day 13 to the end of the observation period. No clinical signs were observed during the course of the study.

Body weights

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

Macroscopic findings

No macroscopic findings were observed at necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The median lethal dose of Octafluoroisobutyl methyl ether after single dermal administration to rats of both sexsx, observed over a period of 14 days is: LD50 (rat) > 2000 mg/kg bw.
Executive summary:

The study has been conducted in accordance with OECD 402 guideline - Acute Dermal toxicity.

Five males and females HanBri: WIST (SPF) rats were treated with Octafluoroisobutyl methyl ether at 2000 mg/kg bw by dermal application.

No deaths occurred during the study.

Exophtlamus was noted in one male animal from test day 13 to the end of the observation period. No clinical signs were observed during the course of the study in all other animals.

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

No macroscopic findings were observed at necropsy.

In conclusion the median lethal dose of Octafluoroisobutyl methyl ether after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat) greater than 2000 mg/kg bw.

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