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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Publication describes investigation of many substances and the procedures are generally described with indication of exemptions in some cases. These cases are not specified so that it is not possible to definately retrace the conditions for one specific substance.

Data source

Reference
Reference Type:
publication
Title:
The single dose toxicity of some glycols and derivatives.
Author:
Smyth H.F. Jr., Seaton J. and Fischer L.
Year:
1941
Bibliographic source:
Journal of Industrial Hygiene and Toxicology 23, 259 - 268

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
less reporting destails. Body weights not reported. Only males examined.
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene oxide
EC Number:
200-849-9
EC Name:
Ethylene oxide
Cas Number:
75-21-8
Molecular formula:
C2H4O
IUPAC Name:
oxirane
Specific details on test material used for the study:
Commercial grade

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Commercial breeders
- Weight at study initiation: 250-300 g
- Diet: ad libitum. Diet was given in the afternoon, doses the following morning.
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Any victim whose death was inconsistent with the indications from others receiving the substance was atopsied, and if found to be infected it was not included in the calculations. Tissues were not studied microscopically because this step was beyond the scope of the preliminary investigation planned.
The data were calculated by method of probits, described by Bliss (1935) and now becoming familiar. No attempt was made to use adequate animals to obtain extreme precision in the LD50 figure, for the use to which such information is put seldom justified extreme accuracy. The precision is indicated by the range of 95% probability.
Doses:
Max concentration fed: 1%
The exact dosages were not reported. Enough dosages were administered to include those at which no animal died and those at which all died. Most deaths occurred with the first 2 days, but all deaths within 14 days of administration of the dose were considered in calculating the LD50.
No. of animals per sex per dose:
Indicated to be generally 10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
no data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
330 mg/kg bw
Based on:
test mat.
95% CL:
> 290 - < 360
Mortality:
Death was delayed about a week; and if deaths only within the first 2 days had been considered, the LD50 reported would usually have been much higher.
Clinical signs:
other: Fatal or near fatal doses produced no narcosis but varying degrees of sluggish depressed functioning. The test substance caused narcosis but in most cases only at the LD50 or above.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In summary, male rats were exposed to concentrations of up to 1% resulting in an LD50 of 330 mg/kg bw.
Executive summary:

An acute oral toxicity study was conducted using ten male Wistar rats exposed to concentrations of 1% as a maximum using the fixed dose procedure. A 14-day observation period was performed and necropsy and clinical signs were performed. Death was delayed about a week; and if deaths only within the first 2 days had been considered, the LD50 reported would usually have been much higher. Fatal or near fatal doses produced no narcosis but varying degrees of sluggish depressed functioning. The test substance caused narcosis but in most cases only at the LD50 or above. The LD50 was reported to be 330 mg/kg bw.