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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant, OECD Guideline 401 study, adequate for assessment. However, no data on analytical purity was reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl methyl ether
EC Number:
216-653-1
EC Name:
tert-butyl methyl ether
Cas Number:
1634-04-4
Molecular formula:
C5H12O
IUPAC Name:
2-methoxy-2-methylpropane
Details on test material:
- Name of test material (as cited in study report): MTBE
- Physical state: colourless liquid
- Analytical purity: not reported

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Fasting period before study: 16 hours
- Housing: 5 animals/sex/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
The test article was used undiluted as supplied by the sponsor at the volume of administration of 2.70 ml/kg, in order to obtain the dose of 2000 mg/kg being the density 0.740 g/ml.

The values to be adminstered were measured with apprpriately gauged plastic syringes.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
Observations of clinical signs and mortality:
at 30 minutes, 2, 4 and 6 hours on the first day after the administration (day 1) and then twice a day up to termination of the observation period (14 days).

Body weight:
twice pre-trial, and on days 3, 8 and 14. On day 1 the animals were weighed after a 16-hour fasting.

Gross pathology:
performed on all animals
Statistics:
No statistical analysis was performed (not needed due to the obtained results)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
other: Animals showed hunching and piloerection starting from 2-4 hours after gavage, which disappeared within 2-6 days.
Gross pathology:
At autopsy at the end of the observation period no appreciable macroscopic findings were evident in any treated rats.

Applicant's summary and conclusion