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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-007-0 | CAS number: 16940-92-4
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1990-1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not a guideline study, but data acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Indium and iridium allergy in patients exposed to dental alloys
- Author:
- Marcusson JA, Cederbrant K and Heilborn J
- Year:
- 1 998
- Bibliographic source:
- Contact Dermatitis 38, 297-298
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The frequency and relevance of positive skin reactions to ammonium hexachloroiridate was investigated in 210 patch tested patients exposed to dental alloys.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dimmonium hexachloroiridate
- IUPAC Name:
- Dimmonium hexachloroiridate
- Details on test material:
- - Name of test material (as cited in study report): ammonium hexachloroiridate.
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Method
- Type of population:
- other: Patients with suspected hypersensitivity to dental materials.
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 210
- Sex: M/F
- Age: The patients with positive patch tests results to various dental materials ranged from 37 to 71 years-of-age
- Race: no data
- Demographic information: Patients attending the Dermatology clinic at Huddinge Hospital, Stockholm, Sweden - Clinical history:
- - History of allergy or casuistics for study subject or populations: All patients had suspected hypersensitivity to dental materials.
- Symptoms, onset and progress of the disease: no data
- Exposure history: dental amalgams
- Aggravating factors both in home and workplace: no data
- Family history: no data - Controls:
- None
- Route of administration:
- dermal
- Details on study design:
- Template option: Skin sensitisation
TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: semi-occlusive
- Description of patch: Finn chamber
- Vehicle / solvent: no data
- Concentrations: 0.01, 0.032, 1% for ammonium hexachloroiridate
- Volume applied: no data
- Testing/scoring schedule: Patch applied for 2 days to the upper back. Readings were made two day after patch removal, and patients were asked to report late reactions.
- Removal of test substance: no data
EXAMINATIONS
- Grading/Scoring system: + weak non-vesicular reaction; ++ strong oedematous vesicular reaction: +++ extreme reaction (only ++ and +++ reactions, or a + reaction for at least two concentrations, were accepted as positive findings.
- Statistical analysis: no data
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: A + reaction was seen in one female at the highest concentration only.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1/210
- Number of subjects with negative reactions: 209/210
Applicant's summary and conclusion
- Conclusions:
- Only one female (out of 210 patients) had a weak positive reaction to 1% diammonium hexachloroiridate two days after removal of a 48-hr, semi-occluded, patch test.
- Executive summary:
A total of 210 patients with suspected hypersensitivity to dental materials were patch tested with 0.01, 0.032 and 1% diammonium hexachloroiridate, and assessed for frequency and relevance of positive reactions (indicative of sensitisation). Patches were applied semi-occluded (Finn chamber) for two days to the upper back. Readings were made 2 days after patch removal, and in addition patients were asked to report any late reactions. Reactions were graded as + (weak non-vesicular reaction), ++ (strong oedematous vesicular reaction) or +++ (extreme reaction).
A 42-year-old female had a weak reaction to 1% diammonium hexachloroiridate. No other positive reactions indicative of skin sensitisation were reported.
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.