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Diss Factsheets
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EC number: 282-780-4 | CAS number: 84418-68-8
- 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
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Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Industry initiated study, accepted for EU risk assessment for zinc oxide, reliable study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
- Principles of method if other than guideline:
- cutaneous penetration and absorption through pig skin in vitro
- GLP compliance:
- yes
Test material
- Reference substance name:
- Zinc oxide
- EC Number:
- 215-222-5
- EC Name:
- Zinc oxide
- Cas Number:
- 1314-13-2
- Molecular formula:
- ZnO
- IUPAC Name:
- oxozinc
- Details on test material:
- suspension of zinc oxide
Constituent 1
Test animals
- Species:
- other: pig skin in vitro
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not applicable
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- see results section
- Doses:
- not applicable
- No. of animals per group:
- not applicable
- Details on study design:
- see reference
- Details on in vitro test system (if applicable):
- a solution of ZnO at a concentration of 40 mg/ml in water, were tested for cutaneous penetration and absorption through pig skin in vitro. Skin preparations measuring 1 mm in thickness with stratum corneum, stratum germinativum and blood-vessel-containing parts of the dermis were obtained from pigs using a modified dermatome.
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Absorption in different matrices:
- Dermal absorption of Zn (% of dose) through pig skin in vitro within 72 hours of ZnSO4 application:
receptor fluid: 0.3%, horny layer: 1.3%, residual skin: 0%, potentially absorbed dose: 1.6% - Total recovery:
- Total recoveries of applied zinc ranged from 82.0 to 109.6
- Conversion factor human vs. animal skin:
- see results
Any other information on results incl. tables
Table 1 Dermal absorption of Zn (% of dose) through pig skin in vitro within 72 hoursa
|
ZnSO4 |
ZnO |
Receptor fluid |
0.3 % |
0.03 % |
Horny layer |
1.3 % |
12.3 % |
Residual skin |
0 % |
2.6 % |
Potentially absorbed dose |
1.6% |
14.9% |
aCorrected for background levels of zinc in receptor fluid and skin.
Applicant's summary and conclusion
- Conclusions:
- The authors concluded that dermal penetration of zinc was below 1% based on the cumulative amount recovered from the receptor fluid at 72 hours. However, the amount retained in the skin should be regarded as being absorbed because it may become available at a later stage. Hence, the rapporteur concludes that the dermal absorption of zinc from a solution of zinc sulphate monohydrate and a suspension of zinc oxide in this in vitro system may amount to 1.6% and 14.9%, respectively.
- Executive summary:
Industry initiated anin vitrotesting programme on two representative zinc compounds (zinc oxide and zinc sulphate) for percutaneous absorption (Grötsch, 1999). In this study, a solution of ZnSO4monohydrate and a suspension of ZnO, each at a concentration of 40 mg/ml in water, were tested for cutaneous penetration and absorption through pig skinin vitro. Skin preparations measuring 1 mm in thickness with stratum corneum, stratum germinativum and blood-vessel-containing parts of the dermis were obtained from pigs using a modified dermatome.In two independent experiments for each compound seven skin preparations were mounted in Teflon flow-through diffusion chambers which were continuously rinsed with physiological receptor fluid (0.9% NaCl in aqua bidest with antibiotics). After an integrity check using the marker substance caffeine, each of the test formulations were applied to six skins at a dose of 1 mg/cm2for 8 hours without occlusion, and subsequently washed off with a neutral shampoo. After 0, 2, 4, 6, 8, 16, 24, 40, 48, 64 and 72 hours, the cutaneous permeation was determined by quantifying zinc with atomic absorption spectroscopic analysis (detection limit: 10 ng/ml) in the receptor fluid. The experiment was stopped at 72 hours. Furthermore, zinc was analysed in the skin preparations and the rinsing fluids. In addition, blanks were measured in an unloaded control chamber.
Total recoveries of applied zinc in both experiments ranged from 82.0 to 109.6%. The results of analysis of the receptor fluid used and of the blank chambers without topical application of zinc compounds indicated that both the receptor fluid and porcine skin contain an intrinsic level of zinc. The amounts of zinc detected in receptor fluid and different layers of the skin were therefore corrected for background levels.
The authors concluded that dermal penetration of zinc was below 1% based on the cumulative amount recovered from the receptor fluid at 72 hours. However, the amount retained in the skin should be regarded as being absorbed because it may become available at a later stage. Hence, the rapporteur concludes that the dermal absorption of zinc from a solution of zinc sulphate monohydrate and a suspension of zinc oxide in thisin vitrosystem may amount to 1.6% and 14.9%, respectively.
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.
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