Registration Dossier

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, non-guideline study, published in peer-reviewed literature, minor restrictions in design and reporting, but otherwise adequate for assessment.

Data source

Reference
Reference Type:
publication
Title:
Experimental acute toxicity of vinyl chloride (monochloroethene).
Author:
Prodan L, Suciu V, Pislaru V, Ilea E, Pascu L
Year:
1975
Bibliographic source:
Ann NY Acad Sci 246:154-158.

Materials and methods

Principles of method if other than guideline:
Exposure of rats for 2 h to the test substance in gas chambers according to Krakov's method
GLP compliance:
no
Test type:
other: Krakov's method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chloroethylene
EC Number:
200-831-0
EC Name:
Chloroethylene
Cas Number:
75-01-4
Molecular formula:
C2H3Cl
IUPAC Name:
chloroethene
Details on test material:
Not reported.

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No age, weight and source were indicated.

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: gas chambers of the Pravdintype
- Exposure chamber volume: 580 l
- Gas was continuously stirred in the chamber by an inside pellet.


TEST ATMOSPHERE
- Brief description of analytical method used: volumetrically with a Zimmermann type spirometer

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
2 h
Concentrations:
Concentrations: 15% (375.0 mg/l), 16% (400 mg/l), 17% (425.0 mg/l), 20% (500.0 mg/l), or 21% (525.0 mg/l).
No. of animals per sex per dose:
Number of animals in total = 70
Number of animals per dose: N=30, 10, 10, 10, 10, 10 for exposure to 15% (375.0 mg/l), 16% (400.0
mg/l), 17% (425.0 mg/l), 20% (500.0 mg/l) and 21 (525 mg/l), respectively
Control animals:
no
Details on study design:
Examinations performed: clinical signs, necropsy

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LC50
Effect level:
390 mg/L air (nominal)
Exp. duration:
2 h
Mortality:
Number of deaths at each dose: 375 mg/l (7/30), 400 mg/l (8/10), 425 mg/l (9/10), 500 mg/l (9/10), 525 mg/l (10/10). The majority of deaths at each dose occurred during the first hour of exposure.
Clinical signs:
other: Death of animals preceded by excitement, contractions, convulsions, and respiratory excitement followed by failure. Intensive salivation and lacrimation were noted.
Gross pathology:
Necropsy Findings: General congestion of all internal organs.
Other findings:
Potential Target Organs: Lungs, liver, kidney

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information: based on LC50 (2hr) rat and when extrapolated with Haber's Law