Registration Dossier
Registration Dossier
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EC number: 201-167-4 | CAS number: 79-01-6
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: Non-GLP, non-guideline study, some restrictions in reporting, nevertheless acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
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 substance name:
- Trichloroethylene
- EC Number:
- 201-167-4
- EC Name:
- Trichloroethylene
- Cas Number:
- 79-01-6
- Molecular formula:
- C2HCl3
- IUPAC Name:
- 1,1,2-trichloroethene
- Reference substance name:
- trichloroethene
- IUPAC Name:
- trichloroethene
- 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.
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- 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 or test system 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:
- other: Not reported.
- Gross pathology:
- Not reported.
- Other findings:
- Not reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50 >5000 mg/kg
- Executive summary:
Oral LD50>5000 mg/kg
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