Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-compliant near-guideline study, no restrictions, fully adequate for assessment. However, no analytical purity of the tested ETBE sample was reported.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
EC Number:
EC Name:
Cas Number:
tert-butyl ethyl ether
Details on test material:
Ethyl-tert-Butyl Ether (ETBE), identification no. LF-9072, was purchased from Aldrich Chemical Company (Milwaukee, WI; Lot No. 00423HW) and received July 12, 1989; it was stored refrigerated (approximately 4°C) and was a clear, colorless liquid.

Test animals

New Zealand White
Details on test animals or test system and environmental conditions:
New Zealand albino rabbits were purchased from Johnson Rabbit Ranch (Wilkinson, IN) for use in this study. Upon arrival (5/24/89), the rabbits were held in quarantine for approximately twelve weeks and examined carefully to ensure their health and suitability as test subjects.
Each rabbit was provided approximately 150 g of Purina Lab Rabbit Chow HF #5326 (Ralston Purina Co., St. Louis, MO) daily. Reverseosmosis- purified water was provided ad libitum by means of an automatic watering system.
The rabbits were housed individually in stainless steel cages measuring 61.0 x 45.5 x 41.0 cm. Poly pads (12 ply, Shepherd Specialty Papers, Kalamazoo, Ml) were placed in the pan below the stainless steel mesh floor of each animal cage to absorb liquids. Air-conditioned animal rooms were maintained at approximately 22°C and 60% relative humidity. Fluorescent lighting was provided for 12 hours followed by 12 hours of darkness.

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 hours prior to study initiation, fur was clipped from an area of approximately 240 cm2 on the back of each rabbit and the skin was examined for abnormalities. Care was taken to avoid abrading the rabbits' backs.
ETBE (undiluted, equivalent to 2 g/kg bw) was applied uniformly to the shaved dorsum of each rabbit, covered with a surgical dressing under plastic film (occlusion) and held in place by elastic adhesive bandage for 24 hr. The application site was cleaned with light mineral oil and towel dried on removal of the patch.

Duration of exposure:
24 hours
2000 mg/kg bw
No. of animals per sex per dose:
Control animals:
Details on study design:
All test rabbits were observed approximately 1/2, 1-1/2, 2-1/4, 3-3/4 and 5 hours after dosing and at least once per day for 14 days after removal of the wrappings.
Body weights recorded pre-test, weekly and at termination.
The treatment site was observed for signs of dermal irritation on 1, 7 and 14 d after post-dosing.
All rabbits were euthanized by anesthetic overdose at the end of the observation period (8/30/89) and necropsied.
Statistical analyses were used to analyse the results: calculation of standard deviations.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
There were no deaths.
Clinical signs:
other: Dermal irritation (i.e., edema and erythema) was observed within the application sites of all rabbits following removal of the wrappings. Eschar formation was observed at the application site of most rabbits within 5 to 7 days after test article administr
Gross pathology:
Gross pathological findings were within normal limits in seven rabbits. Three females had multiple red foci on the lungs at necropsy, but this was not considered to be treatment related.

Applicant's summary and conclusion