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EC number: 231-106-7 | CAS number: 7439-97-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 1997-02-04 to 1997-02-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study, but reliable with restrictions: - The study was conducted with an Ti-Hg, Cu-Sn Zr-Al alloy containing onla about 24.8% mercury. - The type of coverage should be semi-occlusive, but in this study occlusive dressing was used. - The body weight of the rabbits at the start and at the conclusion of the test was not stated. - The stability of the test item was not stated.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- , 1992-07-17
- Deviations:
- yes
- Remarks:
- , please refer to "Rationale for reliability incl. deficiencies"
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ti-Hg, Cu-Sn Zr-Al alloy
- IUPAC Name:
- Ti-Hg, Cu-Sn Zr-Al alloy
- Details on test material:
- - Name of test material (as cited in study report): MISCELA HY-TQS
- Chemical name: Ti-Hg, Cu-Sn Zr-Al alloy
- Chemical structure: N.A.
- Chemical class: alloys
- Physical state: grey powder
- Analytical purity: > 98 %
- Impurities: mainly oxygen
- Composition of test material, percentage of components: Ti 29.2 % - Hg 24.8 % - Cu 14.8 % - Sn 21.2- Zr 8.4 % - Al 1.6 %
- Batch No.: 01-96
- Preparation date: December 1996
- Stability: stable at room temperature
- Storage condition of test material: room temperature in sealed vessel
- Known conditions that could lead to instability: heating above 100 °C may cause release of mercury vapours
No further information on the test material was stated.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Conelli S.n.c., Via Milano, 61 - 28041 ARONA (Novara - Italy) (Shipping slip No. 219, dated October 2, 1996)
- Age at study initiation: 6 - 7 months old
- Housing: in metal cages measuring 62x47.5x38h cm with stainless steel feeders. The cages were hung on metal racks over a stainless feeder. The cages were periodically flushed away by a time-programmed siphon system from above.
- Diet (ad libitum): a diet coded "2 RB 15 GLP Certificate" produced by the Charles River Italia's feed licensee Mucedola S.r.l., Settimo Milanese. The Producer supplemented the diet with vitamins and trace elements.
- Water: filtered water (from municipal water main)
- Acclimation period: animals were clinically observed every day.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C +/- 2
- Relative humidity: 50 % +/- 15
- Air changes: 20 air changes per hour (filtered on HEPA 99.97 %)
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test article (moistened with 1 ml of tap water, to ensure good contact with the skin) was applied.
No further information on the amount/concentration applied was stated. - Duration of treatment / exposure:
- One rabbit: 3-minute, 1-hour and 4-hour exposure periods
Two rabbits: 4-hour exposure period - Observation period:
- Observations were performed immediately and 72 hours after the 3-minute and the 1-hour exposure period in one rabbit and at 1, 24, 48 and 72 hours after the 4-hour exposure period in all rabbits.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Approximately 24 hours before the test, fur was clipped from the trunk of the animals. Care was taken not to abrade the skin.
- The test article (moistened with 1 ml of tap water, to ensure good contact with the skin) were applied to a small area (approximately 6 cm^2) of skin.
- In the first instance one rabbit was used and three treatment sites of the skin were prepared. On the first site the test article was applied for an exposure period of 3 minutes. Since no gross skin reactions were noted, the test article was applied for an exposure period of 1 hour on the second site. The application area was covered witha gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape (occlusive patch). Since no gross reactions were observed after the one-hour exposure period, the test article was applied for an exposure period of 4 hours on the third skin site. This area was covered with a gauze patch as above.
- The test was completed using two additional animals with a 4-hour exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was gently removed using water without altering the integrity of the epidermis.
- Time after start of exposure: at the end of each exposure time.
SCORING SYSTEM: Draize scoring system
- Dermal irritation was evaluated in conjunction with the nature and reversibility or otherwise of the responses observed.
- Adjacent areas of untreated skin of each animal served as control for the test.
OBSERVATIONS
- Inspections for mortality and general clinical signs were made once a day.
No further information on the study design was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No changes were seen at any test article application site.
- Other effects:
- - No mortality was seen during the study.
- No clinical signs, either general or local (at application sites) were noted in any rabbit.
Any other information on results incl. tables
3-minute exposure period in one rabbit: neither erythema nor eschar was observed.
1-hour exposure period in one rabbit: neither erythema nor eschar was observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article MISCELA HY-TQS is considered as non-irritant for the skin.
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