Registration Dossier
Registration Dossier
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EC number: 943-336-1 | CAS number: -
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 May 1992 to 20 May 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Reinhardt, 1971, 1973 "Cardiac arrhythmias and aerosol sniffing" Archives Environ. Health, vol 22, pp 265-269; Epinephrine induced cardiac arrhythimia poetential of some common industrial solvents, Journal of Occupational Medicine, vol 15, pp 953-955.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- T-5333
- IUPAC Name:
- T-5333
- Details on test material:
- - Name of test material (as cited in study report): T-5333
- Physical state: liquid
- Lot/batch no.: 3M1 D98-0211-5605-8 Lot 647
Constituent 1
Results and discussion
Any other information on results incl. tables
Sex: male
Endpoint: EC50
Effect level: > 17 % v/v
Remarks: No cardiac effects noted at the highest exposure concentration.
Mortality: None
Clinical signs: Various observations included in tables in study report (see attached) but no clinical signs exclusively recorded. ECG results were analyzed for cardiac sensitization determination.
Any other information on results incl. tables: Tables and appendices in attached study report.
Interpretation of results: relatively harmless
Applicant's summary and conclusion
- Conclusions:
- Cardiac Sensitization EC50 > 17.0%.
- Executive summary:
This study was designed to assess the cardiac sensitization potential of the test article in beagle dogs. Adrenaline was administered by intravenous injection before and during inhalation of the test article. The effect of the adrenaline on the ECG pattern was examined. Positive evidence of cardiac sensitization would be observed as the presence of multiple multifocal ectopic beats of ventricular fibrillation following adrenaline administration during inhalation of the test substance. No such effect should be observed in the absence of the test substance. The test article was administered at concentrations of 5, 10, and 17% v/v. There was no evidence of cardiac sensitization at any dose level.
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