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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 237-706-5 | CAS number: 13933-32-9
- 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:
- 01-Jan-1976 to 31-Dec-1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not a guideline study, but data are scientifically acceptable in the context of an occupational cross-sectional study
Data source
Reference
- Reference Type:
- publication
- Title:
- 20 Years of medical surveillance on exposure to allergenic and non-allergenic platinum compounds: the importance of chemical speciation
- Author:
- Linnett PJ & Hughes EG
- Year:
- 1 999
- Bibliographic source:
- Occupational and Environmental Medicine, 56, 191-196
Materials and methods
- Type of sensitisation studied:
- respiratory
- Study type:
- survey
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Longitudinal/cohort study
Analysis of 20 year data on exposure to soluble platinum compounds and medical surveillance results to confirm that tetraammine platinum dichloride is not allergenic. - GLP compliance:
- no
- Remarks:
- GLP not applicable to this type of study
Test material
- Reference substance name:
- Tetraammine platinum dichloride
- IUPAC Name:
- Tetraammine platinum dichloride
- Reference substance name:
- [(NH3)4Pt]Cl2
- IUPAC Name:
- [(NH3)4Pt]Cl2
- Reference substance name:
- TPC
- IUPAC Name:
- TPC
- Test material form:
- other: Airborne [possibly particulate matter]
Constituent 1
Constituent 2
Constituent 3
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Subjects:
- Total number of persons in cohort from which data were generated: 547 (in 3 process areas); sub-group of chemical processs operators (CPOs; exposed to soluble platinum for at least 50% of their work) identified within each exposure group, total n=341
EXPOSURE DATA
- DURATION
New employees who started work between 01-Jan-1976 and 31-Dec-1995, followed up until 31-Dec-1995, were considered for inclusion the study. Criteria for inclusion:
- no previous exposure to soluble platinum compounds
- work gave regular exposure to soluble platinum compounds which required subjects to undergo medical surveillance
- employed for long enough to have at least one medical examination (these were performed every 3 months)
- CATEGORIES
3 exposure categories to airborne soluble platinum, including TPC:
- PGM refinery (n=406, CPOs=270); workers exposed to chloroplatinates, but not TPC; lowest Pt exposure of the 3 groups
- TPC lab (n=41; CPOs=31); workers regularly exposed to TPC and chloroplatinates; highest Pt exposure of the 3 groups
- Autocat (n=100; CPOs=40); exposure to TPC only; group with intermediate Pt exposure
SUBJECT DESCRIPTION
PGM refinery: total n=406; 373 men, 33 women; mean age 29 years (range 18-61); 199 smokers; 1 atopic
TPC lab: total n=41; 40 men, 1 woman; mean age 25 years (range 17-47); 11 smokers; 0 atopic
Autocat: total n=100; 85 men, 15 women; mean age 26 years (range 16-61); 33 smokers; 4 atopic
A sub-group of chemical processs operators (CPOs; exposed to soluble platinum for at least 50% of their work) was identified within each exposure group, with the following characteristics:
- PGM refinery: total n=270; 257 men, 13 women; mean age 30 years (range 18-59); 164 smokers; 0 atopic;
- TPC lab: total n=31; 31 men, 0 women; mean age 25 years (range 17-47); 9 smokers; 0 atopic;
- Autocat: total n=40; 40 men, 0 women; mean age 29 years (range 16-61); 17 smokers; 0 atopic
MEDICAL SURVEILLANCE ROUTINE
Enquiry about symptoms and skin prick tests every 3 months with 3 platinum salts (ammonium hexachloroplatinate up to 1994, sodium hexachloroplatinate throughout, sodium tetrachloroplatinate up to 1992, TPC from 1992 onwards) at 10 mg/ml in glycerol carbol saline or 0.9% saline; spirometry every 6 months. Positive responses (> or = to 2 mm dimaeter weal) were followed up with further testing.
SUBJECT TRANSFERS
11 employees (8 CPOs) from the PMG refinery transferred to the Autocat; 1 CPO from the TPC group and 1 from the Autocat transferred to the PGM refinery. Subjects who transferred between operations were considered to have withdrawn at the date of transfer and were not included in the analysis for the operation to which they transferred. - Clinical history:
- Pre-employment medical examination; no atopic subjects employed in production jobs; 5 in office jobs in the original cohort.
- Controls:
- No control groups were included; comparisons were made between the 3 exposure groups.
- Route of administration:
- inhalation
- Details on study design:
- Occupational exposure was to TPC and/or chloroplatinates (depending on exposure group). Incidences of sensitisation within the first 5 years (60 months) of employment were evaluated in relation to exposure categories, in both the full cohort (547) and the subset of workers exposed to airborne soluble platinumfor at least 50% of their work 341). TPC/chloroplatinate exposures could not be measured separately when both substance types were airborne.
Results and discussion
- Results of examinations:
- FULL COHORT
PGM refinery (lowest exposure to airborne soluble platinum, exposure to chloroplatinates only, i.e. not TPC): 110/406 cases of sensitisation (27%); 106/270 cases (39%) in the CPO sub-group
TPC lab (highest exposure to airborne soluble platinum, exposure to TPC and chloroplatinates): 5/41 cases of sensitistation (12%); 5/31 cases (16%) in the CPO sub-group; probability of sensitisation was significantly less than in the PMG refinery (p<0.05), relative risk (with 95% confidence interval) reported as 0.33 (0.14-0.78).
Autocat (intermediate exposure to airborne soluble platinum, exposure to TPC only): 0/100 cases of sensitisation (0%); 0/40 cases (0%) in the CPO sub-group; probability of sensitisation was significantly less than in the PMG refinery (p<0.001) and the TPC lab (p<0.05), relative risk 0.00
CPO SUB-GROUP
PGM refinery, no relationship between probability of sensitisation and age at the start of employment; strong evidence of a relationship with smoking; smoking-adjusted RRs (with 95% CI) for the TPC lab and the Autocat groups, compared with the PGM refinery group, were 0.47 (0.20-1.12; not statistically signficant) and 0.00 (p<0.001)
PGM refinery(lowest exposure to airborne soluble platinum, exposure to chloroplatinates only, i.e. not TPC): median time to diagnosis of sensitisation 13 months (range 1-108 months); 80/106 cases diagnosed in first 2 years of employment; 1.4 cases/100 person-months in the first 5 years of employment
TPC lab (highest exposure to airborne soluble platinum, exposure to TPC and chloroplatinates): median time to diagnosis of sensitisation 37 months (range 7-52 months); 0.5 cases/100 person-months in the first 5 years of employment
Autocat (intermediate exposure to airborne soluble platinum, exposure to TPC only): no cases of sensitisation in CPO sub-group or this group in the original cohort
Sensitisation incidence calculations were restricted to first 60 months of employment to prevent long-term "survivor" bias.
Any other information on results incl. tables
"Supports the original study [Cleare MJ et al., 1976. Clin Allergy, 6, 183], which showed a lack of response to TPC in subjects who were sensitive to chloroplatinates."
Applicant's summary and conclusion
- Conclusions:
- Tetraammine platinum dichloride showed a lack of allergenic potential in an occupational study involving 547 workers exposed to airborne TPC, chloroplatinates or a combination thereof (341 of whom were exposed to soluble platinum for at least 50% of their work).
- Executive summary:
This longitudinal cohort was designed to investigate the allergenic potential of tetraammine platinum dichloride (TPC) in groups of workers exposed airborne concentrations of this and/or chloroplatinate salts. Of 341 chemical process operators exposed to soluble airborne platinum for at least 50% of their work, those with lowest exposure to total platinum (no TPC exposure) exhibited 1.4 cases of sensitisation/100 person months in the first 5 years of employment; those with the highest exposure to total platinum (a combination of TPC and chloroplatinates) exhibited 0.5 cases/100 person-months; none of those exposed to TPC alone (intermediate total Pt exposure) displayed any indications of sensitisation. Smoking-adjusted relative risk for intermediate TPC exposure vs. no TPC exposure was 0.00 (p<0.001). The authors concluded that this study "confirms the allergenic potential of the complex halogenated salts of platinum and shows the lack of effect attributable to TPC alone"; and that "the soluble platinum compound TPC is not allergenic under normal industrial conditions".
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.