[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08/Sep/04 - 29/Aug/05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Notification No 8147

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

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

Specific details on test material used for the study:

Asahiklin AE-3000, molecular weight 200.07
CAS 406-78-0
Clear colourless liquid
Batch 50407070
Purity: 99.985%
The test substance was stored in a refrigerator in the dark under stable conditions
The test substance expiry date was the 07 July 2005

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The rats were provided by Charles River Deutschland, Sulzfeld, Germany. The female rats used were nulliparous and non-pregnant. Only young adult animals were selected (approx. 8 weeks old) and the rats were identified by an earmark. Body weight variation of the test animal did not exceed ± 20% of the sex mean. A health inspected was performed before treatment, with special attention paid to the skin to be treated, which was intact and free from abnormalities.

The test animals were housed in a controlled optimal environment (15 air changes per hour, temperture of 21.0 ± 3°C (actual range 20.3 - 23.0°C), relative humidity of 30-70% (actual range 35-87%, potentially caused by cleaning procedures in the room), and 12 hours artificial fluorescent light/ 12 hours of darkness per day). Additionally, the test animals were individually housed in labelled Macrolon cages (MIII type), containing sterilised sawdust as bedding and paper as cage-enrichment. An acclimatisation period to the laboratory conditions took place for 5 days prior to treatment, during which the animals were group housed in Macrolon cages (MIV type).

The test animals had free access to standard pelleted laboratory animal diet and tap water.

Results of analysis for each batch of diet (nutrients) and results of quarterly analysis of diet (contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day before exposure, an area of approx. 5x7cm on the back of the animal was clipped. The test substance was then applied in an area of approx. 10% of total body surface. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch successively covered with aluminium foil and Coban elastic bandage. A piece of micropore tape was additionally used for fixation of the bandages in females.

Duration of exposure:

24 hours

Doses:

Single dosage on day 1

No. of animals per sex per dose:

5

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred

Clinical signs:

other: Chromodacryorrhoea, hunched or flat posture, ptosis and/or piloerection were notes among the animals on days 1 and/or 2. Focal erythema and/ or scales were seen in the treated skin-area of two females between days 3 and 6. One female showed brown staining

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 value of 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether in Wistar rats has been established to exceed 2000mg/kg body weight. Based on the experimental findings, 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether does not have to be classified and has no obligatory labelling requirement for dermal toxicity, according to:
OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances
EC criteria for classification and labelling requirements for dangerous substance and preparations

Executive summary:

1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether was administered to five Wistar rats of each sex by a single dermal application at 2000mg/kg body weight for 24 hours. Animals were then subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on day 15 of the study. Throughout the study, no mortalities occurred. Chromodacryorrhoea, hunched or flat posture, ptosis and/ or piloerection were noted among the animals on days 1 and/or 2. Additionally, focal erythema and/ or scales were seen in the treated skin-area of two female rats between days 3 and 6. One female also showed brown staining of the back on days 4 and 5. Post mortem examination of the animals did not reveal any macroscopic abnormalities.

From the experimental findings, the dermal LD50 value of 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether in Wistar rates was established to exceed 2000mg/kg body weight. Based on these results, 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether does not have to be classified and has no obligatory labelling requirement for dermal toxicity.