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Diss Factsheets
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EC number: - | CAS number: -
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Identification of Metal Allergens in the Local Lymph Node Assay
- Author:
- David A. Basketter, Linda J. Lea, Karen J. Cooper, Cindy A. Ryan, G. Frank Gerberick, Rebecca J. Dearman, and Ian Kimber
- Year:
- 1 999
- Bibliographic source:
- American Journal of Contact Dermatitis, Vol IO, No 4 (December), 1999:pp 207-212
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 July, 2010
- Principles of method if other than guideline:
- - Principle of test:
Test conducted similar to OECD guideline 429
- Short description of test conditions:
Groups of 4 CBAKa mice were treated with 25 µL of test material, or with an equal volume of the vehicle alone, on the dorsum of both ears. Treatment was performed once daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected by the tail vein with 250 µL of phosphate buffered saline (PBS) containing 20 µCi of tritiated thymidine. Mice were killed 5 hours later and the draining lymph nodes excised and pooled for each experimental group. A single-cell suspension of lymph node cells was prepared by mechanical disaggregation. The lymph node cell suspension was washed twice in an excess of PBS and then precipitated with 5% trichloroacetic acid (TCA) at 4°C for 18 hours. Pellets were resuspended in TCA and the incorporation of tritiated thymidine measured by β-scintillation counting.
- Parameters analysed / observed: cell proliferation measured by incorporation of tritiated thymidine - GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Zinc sulphate
- EC Number:
- 231-793-3
- EC Name:
- Zinc sulphate
- Cas Number:
- 7733-02-0
- Molecular formula:
- H2O4S.Zn
- IUPAC Name:
- zinc sulfate
- Details on test material:
- ZnSO4 is soluble in water, toxicity based on free ion concentration
Constituent 1
- Specific details on test material used for the study:
- Source: Sigma, Poole, UK.
Purity: 99 %
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac, Bicester, United Kingdom)
- Age at study initiation: 7- 12 weeks
- Housing: in groups of four animals
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 5, 10, 25%
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
Groups of 4 CBA/Ca mice were treated with 25 µL of test material, or with an equal volume of the vehicle alone, on the dorsum of both ears. Treatment was performed once daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected by the tail vein with 250 µL of phosphate buffered saline (PBS) containing 20 µCi of tritiated thymidine (2 Ci mmol/L; Amersham International, Amersham, UK). Mice were killed 5 hours later and the draining lymph nodes excised and pooled for each experimental group. A single-cell suspension of lymph node cells was prepared by mechanical disaggregation. The lymph node cell suspension was washed twice in an excess of PBS and then precipitated with 5% trichloroacetic acid (TCA) at 4°C for 18 hours. Pellets were resuspended in TCA and the incorporation of tritiated thymidine measured by B-scintillation counting.
- Criteria used to consider a positive response:
A substance was regarded as a skin sensitizer if, at any test concentration, the proliferation in treated lymph nodes was threefold or greater than that in the concurrent vehicle treated controls.
- Positive control substance(s):
- other: see 'Remarks'
- Statistics:
- Not reported
Results and discussion
- Positive control results:
- From the positive control substances, mercury and cobalt resulted in a SI value of over 3 at least in two of three concentrations and were thus considered as dermal sensitisers.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- at 5 % zinc sulfate
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- at 10% zinc sulfate
- Key result
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- at 25 % zinc sulfate
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS: none reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study similar to OECD guideline 429 (LLNA), zinc sulfate is not considered to be a dermal sensitiser.
- Executive summary:
In a dermal sensitization study similar to OECD guideline 429 (22 July, 2010) with zinc sulfate in DMSO, young adult CBA/CA mice (4/group) were tested in an LLNA. Additionally, besides zinc sulfate, other metal salts were investigated in the LLNA which are known dermal sensitizers and these metal salts are considered to be the positive controls.
No adverse clinical signs or mortality was observed during the study. Stimulation Indices (S.I.) of 1.3, 2.0 and 2.3 were determined with the test item at concentrations of 5, 10 and 25 % in DMSO, respectively. These results indicate that the test substance could not elicit an SI ≥ 3 and is therefore not regarded as skin sensitizer under the conditions of this study.
Proliferation of the treated lymph nodes was in no concentration increased to over 3-fold of that of the vehicle control lymph nodes. Thus, in this study, zinc sulfate is not a dermal sensitizer and does not need to be classified as dermal sensitizer according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
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