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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: All the studies were evaluated under Regulation (EEC) No 793/93.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: European Union Risk Assessment Report (EU-RAR 2008)
Title:
European Union Risk Assessment Report: Tetrachloroethylene, CAS No 127-18-4, EINECS No 204-825-9. Final draft human health report for publication
Author:
Rapporteur: United Kingdom, on behalf of the European Union
Year:
2008

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
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:
no information available

Test animals

Species:
other: mice, rats and dogs
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no information available

Administration / exposure

Route of administration:
other: intratracheal and intraperitoneal
Vehicle:
not specified
Details on exposure:
no information available
Doses:
varying doses were used for multiple species tested
No. of animals per sex per dose:
no information available
Control animals:
not specified
Details on study design:
no information available
Statistics:
no information available

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
450 mg/kg bw
Based on:
test mat.
Remarks on result:
other: rats, intratracheal administration
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 400 - 5 700 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mice, intraperitoneal administration
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: dogs, intraperitoneal administration
Mortality:
In a test involving intratracheal administration (via an indwelling cannula) to unanaesthetised male rats, the “approximate lethal dose” (the lowest causing death within 3 days) for tetrachloroethylene was found to be 0.45 g/kg (McCarty et al, 1992). This value was based on death of single animals dosed at 0.45 and 1.44 g/kg and survival at 0.14 and 0.25 g/kg, the 2 decedents apparently dying very rapidly. All 4 animals showed “moderate” pathological effects in the lungs, as did 1 of the 2 saline-dosed controls, both of which survived. Values for the LD50 following intraperitoneal administration of tetrachloroethylene are available for mice (4.6 g/kg, Klaassen and Plaa, 1966; 5.7 g/kg, Gehring, 1968; 4.4 g/kg, Gradiski et al, 1978) and dogs (3.2 g/kg, Klaassen and Plaa, 1967). The findings of various investigations of liver, kidney, heart and CNS toxicity using the intraperitoneal, subcutaneous and intravenous routes (Plaa et al, 1958; Plaa and Larson, 1965; Osani, 1967; Cornish et al, 1973; DiVincenzo and Krasavage, 1974; Kobayashi et al, 1982; Tham et al, 1984; Warren et al, 1996; Umezu et al, 1997) do not contribute significantly to enhancing understanding of the acute toxicity of tetrachloroethylene by routes of exposure relevant to human health.
Clinical signs:
as described above
Body weight:
no information available
Gross pathology:
no information available
Other findings:
no information available

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the approximate LD50 of tetrachloroethylene administered intratrachealy to male was 450 mg/kg and the intraperitoneal LD50's to mice ranged between 4400 to 5700 mg/kg and to dogs was 3200 mg/kg.
Executive summary:

The acute toxic potential of tetrachloroethylene was evaluated when administered intratracheal and intraperitoneal to rat, mice and dogs. Under the conditions of the study, the approximate LD50 of tetrachloroethylene administered intratrachealy to male was 450 mg/kg and the intraperitoneal LD50's to mice ranged between 4400 to 5700 mg/kg and to dogs was 3200 mg/kg.