Propane, 1,1,1,3,3-pentafluoro-3-methoxy-2-(trifluoromethyl)-

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

Reference substance name:

1,1,1,3,3-pentafluoro-3-methoxy-2-(trifluoromethyl)propane

EC Number:

609-534-4

Cas Number:

382-26-3

Molecular formula:

C5H4F8O

IUPAC Name:

1,1,1,3,3-pentafluoro-3-methoxy-2-(trifluoromethyl)propane

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.