2-ethoxy-2-methylpropane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxy-2-methylpropane

EC Number:

211-309-7

EC Name:

2-ethoxy-2-methylpropane

Cas Number:

637-92-3

Molecular formula:

C6H14O

IUPAC Name:

2-ethoxy-2-methylpropane

Details on test material:

- Name of test material (as cited in study report): ETBE
- Physical state: colourless liquid
- Analytical purity: 95.8%
- Lot/batch No.: 93050601

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Credo
- Age at study initiation: 5-7 weeks
- Weight at study initiation: males: 130-230gram, females: 120-180 gram
- Fasting period before study:
- Housing: 5/sex
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

ETBE was administered undiluted at doses of 500, 1000, 2000 mg/kg bw in a preliminary study in which the animals were obseved for 7 days (per dose 2 males and 2 females).

In the main study: 5 males and 5 females were used (2000 mg/kg). Animals were observed for 14 d, then subject to gross necropsy.

Doses:

2.67 ml/kg, equivalent to 2003 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Examinations for mortality and abnormal clinical signs were made 15 minutes after intubation, then at 1, 2 and 4 hours, and then daily for 14 day observation period.

Weight determinations: the day before treatment, immediate before administration, on days 8 and 15.

A necropsy was performed for all animals.

Statistics:

Statistical analyses were used to analyse the results: calculation of means and standard deviations.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 003 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: The behavior of animals was subdued 1-4 hr post-dosing. All animals were normal at day 2.

Gross pathology:

No unusual macroscopic findings have been detected at necropsy.