Registration Dossier

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:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

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.