Aluminium sulphate

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliable without restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Materials and methods

Type of study / information:

Data from a survey of 495 dentists indicate that most dentists used the mechanical-chemical method of gingival-deflection; 79.39% of those used cord containing epinephrine. It can be concluded that potentially significant amounts of epinephrine can be absorbed systemically from the local anesthetic solution, that secretion of endogenous epinephrine in response to stress occurs, often at levels sufficient to cause measurable changes in hemodynamic variables, and that absorption of epinephrine from impregnated strings occurs.

Endpoint addressed:

basic toxicokinetics

Test guideline

Qualifier:

no guideline followed

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium sulphate

EC Number:

233-135-0

EC Name:

Aluminium sulphate

Cas Number:

10043-01-3

Molecular formula:

Al.3/2H2O4S; General formula Al2(OH)x(SO4)(3-x/2), with x=0 and x=3 and x ranging from 0 to 3.

IUPAC Name:

Aluminium sulphate

Details on test material:

- Name of test material (as cited in study report):Aluminium sulfate

Method

Ethical approval:

confirmed, but no further information available

Exposure assessment:

estimated

Results and discussion

Results:

Data from a survey of 495 dentists indicate that most dentists used the mechanical-chemical method of gingival-deflection; 79.39% of those used cord containing epinephrine. It can be concluded that potentially significant amounts of epinephrine can be absorbed systemically from the local anesthetic solution, that secretion of endogenous epinephrine in response to stress occurs, often at levels sufficient to cause measurable changes in hemodynamic variables, and that absorption of epinephrine from impregnated strings occurs

Any other information on results incl. tables

 The amount of absorption will vary with the exposure of the vascular bed, the length and concentration of the impregnated cord, and the length of time of application. It is possible that the actual total amount of circulating catecholamine would be cumulative, and the corresponding cardiovascular response would be related to the total amount of epinephrine in the bloodstream, regardless of the source. When the fact that we usually have inadequate data on the cardiovascular status of our patients is considered, as well as the tendency to make impressions of multiple prepared teeth, the continued use of epinephrine cord in dentistry must be viewed with alarm.

 Equally effective astringent gingival deflection agents such as alum, aluminum sulfate, and aluminum chloride exert no systemic effects. Therefore, there is little indication for use of epinephrine-containing retraction cords. Adequate medical evaluation, careful use of anesthetics that contain epinephrine, and sedative techniques when indicated will assure the safety of our patients.

Applicant's summary and conclusion

Conclusions:

Astringent gingival deflection agents such as aluminum sulfate exert no systemic effects.

Executive summary:

Data from a survey of 495 dentists indicate that most dentists used the mechanical-chemical method of gingival-deflection; 79.39% of those used cord containing epinephrine. It can be concluded that potentially significant amounts of epinephrine can be absorbed systemically from the local anesthetic solution, that secretion of endogenous epinephrine in response to stress occurs, often at levels sufficient to cause measurable changes in hemodynamic variables, and that absorption of epinephrine from impregnated strings occurs. The amount of absorption will vary with the exposure of the vascular bed, the length and concentration of the impregnated cord, and the length of time of application. It is possible that the actual total amount of circulating catecholamine would be cumulative, and the corresponding cardiovascular response would be related to the total amount of epinephrine in the bloodstream, regardless of the source. When the fact that we usually have inadequate data on the cardiovascular status of our patients is considered, as well as the tendency to make impressions of multiple prepared teeth, the continued use of epinephrine cord in dentistry must be viewed with alarm. Equally effective astringent gingival deflection agents such as alum, aluminum sulfate, and aluminum chloride exert no systemic effects. Therefore, there is little indication for use of epinephrine-containing retraction cords. Adequate medical evaluation, careful use of anesthetics that contain epinephrine, and sedative techniques when indicated will assure the safety of our patients.