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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
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Detection of contact sensitivity of metal salts using the murine local lymph node assay
- Author:
- Yoshiaki Ikarashi, Toshie Tsuchiya and Akitada Nakamura
- Year:
- 1 992
- Bibliographic source:
- Toxicology Letters, 62 (1992) 53-61
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Copper (II) sufate pentahydrate
- Cas Number:
- 7758-99-8
- Molecular formula:
- CuSO4 · 5H2O
- IUPAC Name:
- Copper (II) sufate pentahydrate
1
- Specific details on test material used for the study:
- Source: Wako Pure Chemical Industries, Ltd., Osaka, Japan.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 6-8 weeks
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol (20 %)
- Concentration:
- 10%
- No. of animals per dose:
- 3
- Details on study design:
- TREATMENT PREPARATION AND ADMINISTRATION:
The mice (n = 3) received 25 µL of test chemical solution, or vehicle alone, on the dorsum of each ear. The application was repeated for three consecutive days. In some experiments, the dorsal surface of each ear was gently abraded by lightly dragging a 19-g needle across the dorsal surface of each ear five times (without causing bleeding) just prior to the application of test chemicals. Four days following the initial application, mice were killed and the draining lymph nodes (auricular and axillary) were excised and pooled per animal. A single cell suspension of LNC was prepared by mechanical disaggregation through sterile 200-mesh steel gauge. Lymphocyte suspensions were washed twice in phosphate-buffered saline (PBS) and resuspended in RPMI-1640 culture medium supplemented with 10% fetal calf serum (FCS), 25 mM N-2-hydroxyethylpiperazine-N’-2-ethanesulfonic acid (Hepes), 100 µg/ml penicillin and 100 U/ml streptomycin. The cell concentration was adjusted to give 5 E+06 cells/mL.. Lymphocyte suspensions were seeded into 96-well microtiter plates at a concentration of 1 E+06 cells/well (5 wells per animal), and cultured with 0.5 µCi [3H]methyl thymidine ([3H]TdR) for 18 h at 37°C in a humidified atmosphere of 5% CO2 in air.
Culture was terminated by automatic cell harvesting. The incorporation of [3H]TdR was measured using a liquid scintillation counter and expressed as mean counts per min (cpm) ± standard deviation per node of three animals for each test group. Increases in [3H]TdR incorporation relative to vehicle-treated controls were calculated for each test group, and expressed as stimulation indices (SI). - Positive control substance(s):
- other:
Results and discussion
- Positive control results:
- The SI values observed with CoCl2 and K2Cr2O7 were 4.3 and 3.1, respectively.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 2.67
- Test group / Remarks:
- 10 % copper sulfate pentahydrate in 20 % ethanol solution
- Parameter:
- SI
- Value:
- 4.33
- Test group / Remarks:
- positive control CoCl2
- Parameter:
- SI
- Value:
- 0
- Test group / Remarks:
- negative control, 20 % ethanol solution
- Parameter:
- SI
- Value:
- 3.16
- Test group / Remarks:
- positive control K2Cr2O7
- Cellular proliferation data / Observations:
- In the present study only the results from one treatment group were reported.
Any other information on results incl. tables
THE LOCAL LYMPH NODE ASSAY PERFORMED WITH FIVE METAL SALTS
Chemical |
[3H]TdR incorporation (mean cpm±SD (x 10-3) |
SI |
20% EtOH |
1.52± 0.67 |
- |
10% FeSO4 |
2.03±0.63 |
1.32 |
10% MnCl2 |
1.26±0.08 |
0.82 |
10% ZnSO4 |
2.14±0.77 |
1.41 |
10% CuSO4 |
4.08±1.20 |
2.67 |
10% NiSO4 |
3.56±0.25 |
2.32 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present study conducted by Ikarashi et al. (1992), copper sulfate pentahydrate is not considered to be a sensitizer in the LLNA.
- Executive summary:
In the present study conducted by Ikarashi et al. (1992), copper sulfate pentahydrate was dissolved in 20% ethanol and applied to the dorsal surface of the ear on three consecutive days. After four days after initial application the mice were killed and the draining lymph nodes were dissected and incubated for 18 hours at 37°C in humidified air with [3H]TdR. After the incubation period the [3H]TdR incorporation was detected and the SI was determined.
Incubation with 10% CuSO4 in 20% ethanol resulted in a SI value of 2.67. Thus, under the conditions of the present test, the substance was not considered a sensitizer.
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