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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, near guideline study, published study report, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
standard acute 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: 99.9%- Lot/batch No.: TA03116F-01 - Stability under test conditions: yes. Tetrachloroethylene was found to be stable for 2 weeks at 60ºC- Storage condition of test material: stored at 0ºC

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Frederick Cancer Research Center- Age at study initiation: 5-7 weeks- Housing: stainless steel mesh, 1 animal per cage- Diet: ad libitum, except during inhalation exposure- Water: ad libitum, also during inhalation exposure- Acclimation period: 7 daysENVIRONMENTAL CONDITIONSdata not reported

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTIONTetrachloroethylene vapor generated by bubbling clean, dry air (-40ºC dewpoint) through all glass impingers that contained tetrachloroethylene; the different concentrations obtained by varying the amount of air that was passed through the test material.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
2445, 3786, 4092, 4513 or 5163 ppm
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were observed daily and weighed on days 0 and 15. Necropsy was performed on all animals.
Statistics:
not reported

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
other: lowest concentration causing mortality
Effect level:
3 786 ppm
Exp. duration:
4 h
Mortality:
All the rats that were exposed to 5163 ppm died before the end of the study, and deaths also occurred in all but the lowest dose groups.Survival: 5/5, 4/5, 3/5, 3/5, 0/5 (males) and 5/5, 1/5, 2/5, 2/5, 0/5 (females) in dose groups 2445, 3786, 4092, 4513, and 5163 ppm respectively.
Clinical signs:
other: Hypoactivity, ataxia, and anesthesia were observed in all dosed groups.
Body weight:
Mean body weight gain was not dose related.
Gross pathology:
No effects were reported.

Applicant's summary and conclusion