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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
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

Constituent 1
Chemical structure
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.

Applicant's summary and conclusion