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EC number: 237-399-8 | CAS number: 13770-92-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 442E
- GLP compliance:
- yes
- Type of study:
- activation of dendritic cells
Test material
- Reference substance name:
- Calcium disulphamate
- EC Number:
- 237-399-8
- EC Name:
- Calcium disulphamate
- Cas Number:
- 13770-92-8
- Molecular formula:
- Ca.2H3NO3S
- IUPAC Name:
- calcium disulfamate
Constituent 1
- Specific details on test material used for the study:
- Name of test substance: Calcium disulphamate
Test-substance No.: 16/0399-1
Batch identification: GM0056-WRS-0220
CAS No.: 13770-92-8
Content: 90.9 g/100 g (see report no.: 16L00478) 90.9% was used for calculation of 100 mM concentration (DPRA) and maximum concentration used for LuSens and h-CLAT)
Identity: confirmed (see report no.: 16L00478)
Homogeneity: The test substance was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility. The test facility is organizationally independent from the BASF SE sponsor division.
Physical state / color: solid, white
Storage conditions: ambient
Molecular weight: 232.25 g/mol
Log KOW: -2.6 (calculated)
Proposed reaction mechanism for protein binding by OECD toolbox (non-GLP system): The OECD toolbox did not indicate an alert for protein binding for either the substance or its predicted metabolites (auto-oxidation, hydrolysis, and skin metabolism).
In vitro test system
- Details on the study design:
- Dendritic cell activation has been identified as one of the key events of the adverse outcome pathway for skin sensitization as identified by the OECD (OECD Publication No.168; ENV/JM/MONO(2012)10). The human cell line activation test (h-CLAT) is a dendritic cell activation test to predict skin sensitizing potential (Ashikaga et al. 2010, Sakaguchi et al. 2010). The test is performed using the human monocytic leukemia cell line THP-1 as surrogate for dendritic cells.
As readout, the change in the expression of the cell membrane markers CD 54 and CD 86 measured by flow cytometry after 24 hours of test substance exposure is determined.
Cell line: THP-1 cells
The human monocytic leukemia cell line was obtained from “American Type Culture Collection, Manassas, USA” (ATCC, TIB-202).
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Parameter:
- other: % relative fluorescence intensity CD86
- Value:
- 150
- Vehicle controls validity:
- valid
- Parameter:
- other: % relative fluorescence intensity for CD54
- Value:
- 200
- Vehicle controls validity:
- valid
Any other information on results incl. tables
For detailed results see attached document.
Acceptance criteria and historic control data of the h-CLAT
The acceptance criteria mentioned above were met in all experiments. The positive and negative and vehicle control data is comparable to historic data as can be seen in the following table:
Table: Historic control data of h-CLAT. Data shown of test period Jan 2016 until Jun 2017 (not including present study).
Negative Control (LA 1000 µg/mL) |
CD86 RFI [%] |
CD54 RFI [%] |
viabilitymean[%] |
rel. viability mean [%] |
||
Min |
31 |
43 |
95 |
99 |
||
Max |
134 |
184 |
99 |
101 |
||
Mean |
71 |
112 |
98 |
100 |
||
SD |
11 |
18 |
1 |
0 |
||
n (experiments) |
|
|
143 |
|
|
Positive Control (DNCB 4 µg/mL) |
CD86 RFI [%] |
CD54 RFI [%] |
viabilitymean[%] |
rel. viability mean [%] |
||
Min |
151 |
211 |
71 |
73 |
||
Max |
528 |
1893 |
92 |
98 |
||
Mean |
286 |
591 |
84 |
86 |
||
SD |
64 |
270 |
4 |
4 |
||
n (experiments) |
|
|
143 |
|
|
VehicleControl (culturemedium) |
CD86 RFI [%] |
CD54 RFI [%] |
viabilitymean[%] |
|
||
Min |
56 |
68 |
95 |
|
||
Max |
144 |
132 |
99 |
|||
Mean |
100 |
100 |
98 |
|||
SD |
20 |
13 |
1 |
|||
n (experiments) |
|
|
143 |
|
|
Vehicle Control (DMSO) |
CD86 RFI [%] |
CD54 RFI [%] |
viabilitymean[%] |
rel.viabilitymean[%] |
||
Min |
39 |
48 |
90 |
92 |
||
Max |
150 |
189 |
99 |
101 |
||
Mean |
107 |
107 |
98 |
100 |
||
SD |
21 |
18 |
1 |
1 |
||
n (experiments) |
|
|
143 |
|
|
Table: Reactivity check, performed with each new-thawed cells prior to use for a study, using NiSO4, LA, DNCB and the vehicle control (data shown of test period Mar 2015 until Jul 2017).
Negative Control (LA 1000 µg/mL) |
CD86 RFI [%] |
CD54 RFI [%] |
rel.viabilitymean[%] |
Min |
62 |
69 |
99 |
Max |
90 |
169 |
101 |
Mean |
72 |
111 |
100 |
SD |
8 |
25 |
0 |
n (experiments) |
|
18 |
|
Nickel(II)sulfatehexahydrate (NiSo4100µg/mL) |
CD86 RFI [%] |
CD54 RFI [%] |
viability mean [%] |
Min |
222 |
1105 |
61 |
Max |
404 |
3569 |
91 |
Mean |
304 |
2131 |
82 |
SD |
63 |
626 |
7 |
n (experiments) |
|
18 |
|
Positive Control (DNCB 4 µg/mL) |
CD86 RFI [%] |
CD54 RFI [%] |
rel.viabilitymean[%] |
Min |
212 |
223 |
54 |
Max |
428 |
1049 |
93 |
Mean |
310 |
521 |
86 |
SD |
60 |
223 |
9 |
n (experiments) |
|
18 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In summary, after 24 hours of exposure to test substance Calcium disulphamate CD86 and CD54 expression was not induced in THP-1 cells affording at least 50% viability in at least two independent experiments. From this it has to be concluded that test substance Calcium disulphamate does not induce dendritic cell activation.
- Executive summary:
The potential of test substance Calcium disulphamate to induce the cell membrane markers CD86 and CD54 expression was evaluated in the Human Cell Line Activation Test (h-CLAT). For this purpose the test substance was incubated with human monocytic leukemia cell line THP-1 for ca. 24 hours at 37°C and membrane marker expression (CD86 / CD54) was measured by flow cytometry.
In order to determine the concentrations suitable for the main experiment a pre-test (non-GLP) was performed. Cells were exposed to 10 concentrations of the test substance and cytotoxicity was determined thereafter by propidium iodide (PI) intercalation into the DNA. No cytotoxicity was observed.
In the main test after 24-hour exposure THP-1 cells were stained with FITC labeled anti-human-CD86/ anti-human-CD54 antibody and propidium iodide and the fluorescence intensity was analyzed using flow cytometry. A total of 2 experiments were performed.
In summary, after 24 hours of exposure to test substance Calcium disulphamate CD86 and CD54 expression was not induced in THP-1 cells affording at least 50% viability in at least two independent experiments. From this it has to be concluded that test substance Calcium disulphamate does not induce dendritic cell activation.
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