Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrachloroethylene
EC Number:
204-825-9
EC Name:
Tetrachloroethylene
Cas Number:
127-18-4
Molecular formula:
C2Cl4
IUPAC Name:
tetrachloroethene
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 or test system 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:
other: 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.
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