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EC number: 231-141-8 | CAS number: 7440-31-5
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 July 2008 to 25 July 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tin
- EC Number:
- 231-141-8
- EC Name:
- Tin
- Cas Number:
- 7440-31-5
- Molecular formula:
- Sn
- IUPAC Name:
- tin
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material : Tin metal powder (2 – 11 µm)
- Physical state: Solid, grey powder
- Analytical purity: 99.99 %
- Impurities (identity and concentrations): Pb 0.0035 %, Sb 0.0010 %, Cu 0.0003 %, Au 0.0001 %, Al < 0.0001 %, Cd < 0.0001 %, Zn < 0.0002 %, Ag 0.0005 %, Bi 0.0018 %, As 0.0014 %, Fe < 0.0001 %, In 0.0002 %, Ni 0.0002 %, P 0.0016 % and S 0.0028 %
- Purity test date: 05/07/2008
- Lot/batch No.: 061184
- Expiration date of the lot/batch: August 2008
- Storage condition of test material: When not in use the test article was stored in a sealed container, at room temperature in the dark.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three male rabbits obtained from commercial breeder, acclimated for 7-14 days. Hair removed from dorsum on day prior to treatment and animals confirmed to be healthy with intact, undamaged skin. Bodyweights recorded on day of arrival. Housed in standard laboratory cages - diet, water and environmental conditions complied with animal welfare and UK Home Office guidelines. Measures to enrich the environment using chew blocks and hay were included
TEST ANIMALS
- Source: Harlan UK Ltd., Bicester
- Age at study initiation: 12 to 15 weeks
- Weight at study initiation: 2.29 kg to 2.90 kg
- Housing: On arrival, rabbits were accommodated in cages that conform with the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989).
- Diet: Global Diet TRB 2930C (Harlan Teklad, Bicester, UK), freely available to the animals at all times. Each batch of diet had been analysed for specific constituents and contaminants by the manufacturer.
- Water: Mains water was provided, ad libitum, via cage-mounted water bottles. The water had been periodically analysed for specific contaminants.
- Acclimation period: 7 to 21 days
ENVIRONMENTAL CONDITIONS
- Temperature: 15 to 21 °C
- Humidity: 40 to 70 %
- Air changes: 15 per hour
- Photoperiod: The rooms were illuminated by fluorescent strip-lights for twelve hours daily.
In order to enrich both the environment and the welfare of the animals they were, where practicable, provided with wooden Aspen chew blocks and hay.
Overtly healthy animals were arbitrarily allocated to the study on the day prior to dosing. Electric clippers were used to remove all hair from an area of the dorsum measuring approximately 10 x 8 cm. Only rabbits with dorsal skin showing no pre-existing damage, irritation or multiple areas of active hair growth were accepted onto study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of tin metal powder (2-11 µm) per site
The test article was moistened with water before application in order to ensure good contact with the skin. - Duration of treatment / exposure:
- 4 hours under semi-occlusive dressing
- Observation period:
- 72 hours
- Number of animals:
- Initially a single rabbit, followed by a further two animals.
- Details on study design:
- TEST SITE
- Area of exposure: 30 x 20 mm area on the closely clipped dorsum
- Type of wrap if used: The dose was spread uniformly over the designated area and then covered by a dense gauze patch (30 x 20 mm) on Day 1. This in turn was covered by a larger gauze patch (40 x 40 mm) and an open weave, elasticated adhesive compression bandage which was wrapped firmly around the torso to secure the applied dose and patch in the correct position. The dressing was considered to be semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test patch was removed after four hours and the treated skin was lightly brushed clean of any solid residues and swabbed with moist cotton wool. The location of the test site was marked on the dorsum with indelible ink after completion of the cleansing process.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Draize J H (1959) “Dermal Toxicity” in: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p47 ( detailed under section "Any other information on materials and methods incl. tables")
Before the first animal could be dosed, the pH of the test article was checked. A 50 % w/v dispersion in purified water had a pH of 5. Since this was within the acceptable range of pH 2.0 to 11.5, the study continued.
Although no contemporary measurement of pH of the purified water used in the formulation was made, the water comes from one source and is produced on site at Covance, Harrogate from an Elgastat purifier. The typical pH value of the purified water is pH 5.68 (as measured on 03 October 2008)
Each rabbit was weighed on the day before dosing commenced (Day –1).
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 to 72 hour scores
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No reactions occurred at any time point for any any rabbit, so no possibility for reversibility
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No dermal response to treatment was observed in any animal throughout the observation period.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
No dermal reactions were apparent at any site for any of the three rabbits, at any time point from 1 to 72 hours post-exposure.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- The mean scores for erythema and eschar formation and for oedema formation, for each rabbit, were zero. Therefore, the test article did not meet the criteria for classification as irritant or corrosive according to EU criteria.
The test article produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted - Executive summary:
500 mg of tin metal powder (2 -11 µm) was applied to moistened sites on the clipped, shaved dorsum of three NZW rabbits and maintained in situ under a semi-occlusive dressing for 4 hours. The sites were assessed at 1, 24, 48 and 72 hours post-exposure and scored for signs of erythema or oedema according to Draize system. No dermal reactions were observed.
Tin metal powder (2 -11 µm) was not irritating and does not require classification as a skin irritant.
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