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Registration Dossier
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EC number: 216-653-1 | CAS number: 1634-04-4
Acute Toxicity: oral
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:
- 1 996
- 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
- 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
Constituent 1
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
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