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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Animals showed hunching and piloerection starting from 2-4 hours after gavage, which disappeared within 2-6 days.
Body weight:
Body weight resulted unaffected by treatment.
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