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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: Comparable to guideline study, GLP status unknown, published in peer reviewed literature, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
The subchronic toxicity of tetrachloroethylene (perchloroethylene) administered in the drinking water of rats
Author:
Hayes JR, Condie LW and Borzelleca JF
Year:
1986
Bibliographic source:
Fund Appl Toxicol. 7; 119-125

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetrachloroethylene- Analytical purity: 99+%- Lot/batch No.: 1019KJ

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River breeding laboratories (Wilmington, Mass.)- Age at study initiation: 22-30 days of age- Weight at study initiation: males 165-208 g and females 120-175 g- Fasting period before study: 16 hour- Housing: computer randomized, caged individually, and quarantined for 1 week prior to initiation of the study. Maintained in stainless steel wire-bottomed suspended cages, color coded for dosage level- Diet: ad libitum- Water: ad libitum- Acclimation period: 1 weekENVIRONMENTAL CONDITIONS- Temperature (°C): 21-24- Humidity (%): 40-60- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: polyoxityethylated vegetable oil (Emulphor)
Details on oral exposure:
Exposure by gavage following an overnight fast (16 hours).The volume administered was 10 ml/kg bw.The doses were based upon initial range-finding studies (no more details reported).
Doses:
2200-8850 mg/kg for males,2200-5500 mg/kg for females
No. of animals per sex per dose:
eight dosage groups, consisting of five rats per sex per group
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations and weighing: hourly observations were made during the first 9 hr after administration of the substance followed by twice-daily observations for the next 14 days- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
no data

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3 835 mg/kg bw
95% CL:
3 318 - 4 437
Sex:
female
Dose descriptor:
LD50
Effect level:
3 005 mg/kg bw
95% CL:
2 689 - 3 358
Mortality:
All deaths occurred within the first 24 hr with a trend toward decreasing time to death with increasing dosage.
Clinical signs:
Tremors were observed at all doses. Tremors, ataxia, and central nervous system depression preceded death. Gross necropsy findings of the rats that died were essentially negative; hemorrhagic lungs and adrenals were observed in some animals.
Body weight:
No effects were reported.
Gross pathology:
No gross pathology was observed in the animals that survived the 14-day postadministration observation period.
Other findings:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU