Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 233-135-0 | CAS number: 10043-01-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 1 985
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
- Principles of method if other than guideline:
- Data from a survey of 495 dentists indicate that most dentists used the mechanical-chemical method of gingival-deflection;
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Aluminium sulphate
- EC Number:
- 233-135-0
- EC Name:
- Aluminium sulphate
- Cas Number:
- 10043-01-3
- Molecular formula:
- Al2(SO4)3
- IUPAC Name:
- Aluminium sulphate
- Test material form:
- solid: compact
- Details on test material:
- - Name of test material (as cited in study report):Aluminium sulfate
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)