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Diss Factsheets
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EC number: 297-907-9 | CAS number: 93763-87-2 Substance formed by processing of chiefly oxidic material with lead and zinc content in a rotating furnace. Consists primarily of Al2O3, CaO, Fe, FeO and SiO2 with other nonferrous compounds as well as carbon.
- 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)
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:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Macroscopic skin reactions, skin histological changes and epidermal keratin binding of test material were observed in New Zealand White rabbits after 5 d application of test material to skin using both open and occlusive patch methods.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Zinc oxide
- EC Number:
- 215-222-5
- EC Name:
- Zinc oxide
- Cas Number:
- 1314-13-2
- IUPAC Name:
- oxozinc
- Details on test material:
- - Name of test material (as cited in study report): Zinc oxide
- Analytical purity: 98 % (minimum)
- Storage condition of test material: Test suspension in 0.1 % Tween 80 was prepared 24 h before use and stored at 4 °C.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Source: Charing Cross and Westminster Medical School, London, UK
- Weight at study initiation: 2.5-4.0 kg
- Housing: Housed singly
- Diet: R14 pellets (Biosure) (zinc content 74 mg/kg, w/w)
- Water: Tap water
- Acclimation: Acclimatized to conventional restraining boxes before open patch test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±2
- Humidity (%): 45
- Photoperiod (h dark/h light): 12/12
Test system
- Type of coverage:
- other: Both open and occlusive in two different tests
- Preparation of test site:
- other: Clipped
- Vehicle:
- other: 0.1 % Tween 80
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST SOLUTION
- Amount(s) applied (volume): 0.5 mL
- Concentration (if solution): 20 % (w/v) zinc oxide suspension in 0.1 % Tween 80
- pH: 7.4 - Duration of treatment / exposure:
- 5 d
- Observation period:
- Open patch test: Observed during and after 5 d exposure period
Occlusive patch test: On Day 3 and Day 5 - Number of animals:
- Four animals each for control and test groups in both open and occlusive patch test
- Details on study design:
- Open patch test: Eight test sites (5 cm2) were designated, four on each side of the mid-dorsal line. Test suspension or vehicle was applied daily for 5 successive days. The animals were restrained for 30 min to allow test sites to dry. Skin sites were observed during and after 5 d exposure period. Rabbits were killed 24 h after the fifth daily treatment.
Occlusive patch test: Animals were prepared similar to open patch test. Test suspension or vehicle was applied to the skin on a sterile gauze pad that was secured by a hypoallergenic adhesive tape. The trunks of these animals were wrapped in rubberized fabric and impermeable dressing for 3 d. At this stage, dressings were removed and skin sites were evaluated for irritancy. Two rabbits were killed at this stage. The remaining animals were redressed with freshly impregnated gauze pads and then re-examined and killed after a further 2 d.
In both tests, representative samples of each test and control skin sites of killed animals were preserved in 10 % phosphate buffered formalin for histology. Thin sections cut along the anterior-posterior axis were stained with haematoxylin and eosin, or with morin dye, which fluoresces blue-green in the presence of zinc ions and ultraviolet light (to demonstrate zinc binding to epidermal keratin histologically).
SCORING SYSTEM: Not reported
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Score not reported
- Irritant / corrosive response data:
- No obvious reactions were observed in both control and treatment groups in any of the performed tests after 5 d exposure.
- Other effects:
- Histological changes: No evidence of damage was observed.
Morin fluorescence for zinc on skin: No obvious reaction was observed.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results, 20 % w/v zinc oxide was found to be non-irritating to rabbit skin.
- Executive summary:
A study was conducted to evaluate the skin irritation potential of zinc oxide in New Zealand White rabbits by both open and occlusive patch methods.
In open patch test, 0.5 mL of 20 % w/v zinc oxide suspension in 0.1 % Tween 80 or vehicle was applied to clipped sites (5 cm2) of groups of four animals for 5 d. Skin sites were observed during and after 5 d exposure period. Animals were killed 24 h after the fifth daily treatment.
In occlusive patch test, groups of four animals were treated similarly to open patch test, but the test suspension or vehicle was applied to the skin using occlusive dressing for 3 d. After 3 d, dressings were removed and skin sites evaluated for irritancy. Two rabbits were killed at this stage. The remaining animals were redressed with freshly impregnated gauzes and then re-examined and killed after a further 2 d.
In both tests, representative samples of each test and control skin site of killed animals were analysed histologically and stained with morin dye to study epidermal keratin binding of zinc.
No obvious reactions were observed in both control and treatment groups in any of the performed tests after 5 d exposure. No evidence of damage was observed upon histological examination. No morin fluorescence was observed in skin sections.
Based on these results, 20 % w/v zinc oxide was found to be non-irritating to rabbit skin.
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.
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