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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:
supporting study
Study period:
1972-01-12 to 1972-07-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
other:
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name: 1-tert-Butoxy-2,3-epoxypropane
- Purity: 99 %
- Appearance: Colourless liquid
- Solubility at room temperature: <1% for water, >25 % for acetone and benzene

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
126, 252, 500, 1000 and 2000 mg/kg bw
No. of animals per sex per dose:
2 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were weighed and observed at intervals over a two week post feeding or until any weight loss was regained and the animals appeared healthy.
- Necropsy of survivors performed: Yes, the following tissues were examined: trachea, lung, heart, liver, kidneys, adrenal, spllen, pancreas, stomach, small intestine, large intestine and reproductive organs.
Statistics:
Not specified

Results and discussion

Preliminary study:
n.a.
Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
One out of two rats died at 2000 mg/kg bw. No further mortality observed.
Clinical signs:
not specified
Body weight:
No decrease in body weight was observed.
Gross pathology:
From all animals, one animal per dose group were gross pathological assessed. No gross pathological findings were seen in the animals from the three low dose groups (126, 252 and 500 mg/kg bw). In animal 11 from the dose group 1000 mg/kg bw the following findings were reported: (external) There was a very slight accumulation of darkened material near the external naries. In all probability this was increased porphyrin sections. (internal) The mucosal surface of the stomach was slightly edematous. There was no large pocket of edematous fluid as was decribed for the high dose rat. In all probability the diffuse edema was related to treatment. In animmal 02 from the high dose group the following findings were reported: (external) There was a slight accumulation of dark staining material external to the naries. In all probability this was increased porphyrin sections. (internal) The mucousal surface of the stomach contained some edematous type of fluid. This principally was a large accumulation located between the mucosal and underlying musculature. This area was also congested. In all probability this was related to treatment. It could not be determined that this lesion was associated with possibly some trauma associated with the intubation process. No other visble lesions were noted.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In an acute oral toxicity study conducted equivalent to OECD TG 401, the target substance (99% purity) was orally administered to 2 male rats per dose group comprising of concentrations 126, 252, 500, 1000 and 2000 mg/kg bw. The animals were observed for 14 days. Observations were made at frequent intervals to check the body weights. The body weights and the pathological observations had no treatment related effects and no mortality was observed up to 1000 mg/kg bw. One out of two rats treated with 2000 mg/kg bw died. Hence, according to this study, it can be concluded that the LD50 of the substance is 2000 mg/kg bw.
Executive summary:

In an acute oral toxicity study conducted equivalent to OECD TG 401, the target substance (99% purity) was orally administered to 2 male rats per dose group comprising of concentrations 126, 252, 500, 1000 and 2000 mg/kg bw. The animals were observed for 14 days. Observations were made at frequent intervals to check the body weights. The body weights and the pathological observations had no treatment related effects and no mortality was observed up to 1000 mg/kg bw. One out of two rats treated with 2000 mg/kg bw died. Hence, according to this study, it can be concluded that the LD50 of the substance is 2000 mg/kg bw.