Tetrachloroethylene

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: 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

Test material information

Constituent 1

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

3 835 mg/kg bw

95% CL:

3 318 - 4 437

Effect levels 2

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