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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: Non-GLP, non-guideline study, some restrictions in reporting, nevertheless acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Principles of method if other than guideline:
Dose range-finding study for determination of dose levels in a 8-week subchronic study
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Each batch was received in one or more large amber bottles. Containers were stored in the dark at room temperature.

The purity of the trichloroethylene used was determined by gas chromatography and infrared spectroscopy. Minor components subsequently were identified by gas chromatography-mass spectrometry and confirmed with reference standards.
Analyses of gas chromatographic total area data showed the major component to be at least 99% in each batch. Infrared spectra compare well with trichloroethylene reference spectra. The minor components comprise a mixture of stabilizers routinely added to commercial formulations of trichloroethylene. They include 1,2-epoxybutane (0.19%), ethyl acetate (0.04%), epichlorohydrin (0.09%), N-methylpyrrole (0.02%), and diisobutylene (0.03%) . Percentages were determined by FID gas chromatography with standards after completion of the bioassay. No detectable quantities of 1, 1, 2, 2-tetrachloroethane (<5 ppm) or 1,1,1,2-tetrachloroethane (<2 ppm) were indicated by gas chromatography, using reference standards.

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male
Details on test animals and environmental conditions:
The study report only specifies the details on test animals and environmental conditions for the chronic study with trichloroethylene also performed by the NCI.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Groups of 2 animals each were administered a single dose of trichloroethylene in corn oil by gavage by oral intubation and observed for 14 days.
Doses:
Ten dosages were used: 100, 178, 316, 562, 1000, 1420, 3160, 5620, 10000, and 17800 mg/kg.
No. of animals per sex per dose:
2
Control animals:
yes
Details on study design:
Single-dose range-finding studies were conducted with male rats to determine the highest dose to be used in the 8-week subchronic study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: Not reported
- Other examinations performed: Not reported
Statistics:
Not reported.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
other: lowest dose causing death
Effect level:
5 620 mg/kg bw
Mortality:
No mortality was observed below a single dose of 5620 mg/kg bw.
Clinical signs:
Not reported.
Body weight:
Not reported.
Gross pathology:
Not reported.
Other findings:
Not reported.

Applicant's summary and conclusion