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EC number: 937-712-4 | 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
Endpoint summary
Administrative data
Description of key information
OECD 442 C: no prediction due to precipitation of the test material
OECD 442 D: negative
OECD 442 E: positive
As a worst case approach, the test item is considered to be a skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-11-23 to 2018-01-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Qualifier:
- according to guideline
- Guideline:
- other: Direct Peptide Reactivity Assay (DPRA) for Skin Sensitization Testing, DB-ALM Protocol n°154, January 12, 2013
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of study:
- other: (in chemico) reactivity against synthetic peptides with a thiol or amino group
- Details on the study design:
- The in chemico direct peptide reactivity assay (DPRA) enables detection of the sensitising potential of a test item by quantifying the reactivity of test chemicals towards synthetic peptides containing either lysine or cysteine.
- Positive control results:
- The 100 mM stock solution of the positive control (cinnamic aldehyde) showed high reactivity towards the synthetic peptides. The mean depletion of both peptides was 65.38%.
- Key result
- Run / experiment:
- other: cysteine run
- Parameter:
- other: mean peptide depletion [%]
- Value:
- 0.55
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: lysine run
- Parameter:
- other: mean peptide depletion [%]
- Value:
- 0.37
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Acceptance Criteria
The run meets the acceptance criteria if:
- the standard calibration curve has a r² > 0.99,
- the mean percent peptide depletion (PPD) value of the three replicates for the positive control is
between 60.8% and 100% for the cysteine peptide and the maximum standard deviation (SD) for the
positive control replicates is < 14.9%,
- the mean percent peptide depletion (PPD) value of the three replicates for the positive control is
between 40.2% and 69.0% for the lysine peptide and the maximum SD for the positive control
replicates is < 11.6%,
- the mean peptide concentration of the three reference controls A replicates is 0.50 ± 0.05 mM,
- the coefficient of variation (CV) of peptide peak areas for the six reference control B replicates and three reference control C replicates in acetonitrile is < 15.0%.
The results of the test item meet the acceptance criteria if:
- the maximum standard deviation (SD) for the test chemical replicates is < 14.9% for the cysteine
percent depletion (PPD),
- the maximum standard deviation (SD) for the test chemical replicates is < 11.6% for the lysine
percent depletion (PPD),
- the mean peptide concentration of the three reference controls C replicates in the appropriate solvent is 0.50 ± 0.05 mM.
Both peptide runs and the test item results met the acceptance criteria of the test. - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In this study under the given conditions the test item showed minimal reactivity towards the cysteine peptide. Due to the observed precipitation the prediction
model does not apply and a prediction cannot be made.
The data generated with this test should be considered in the context of integrated approached such as IATA, combining the result with other complementary
information, e.g. derived from in vitro assays addressing other key events of the skin sensitisation AOP. - Executive summary:
In the present study the test item was dissolved in DMF, based on the results of the pre-experiments. A maximum solubility of 37.5 mM was determined. However, in the main experiments stock solutions of 100 mM were prepared accidentally. It is assumed that not the whole amount of test item was dissolved. Since with this concentration the highest possible concentration was guaranteed, the experiments were not repeated. For reasons of simplicity the concentrations of the stock solutions are reported as 100 mM. Based on a molecular weight of 348.47 g/mol a 100 mM stock solution was prepared. The test item solutions were tested by incubating the samples with the peptides containing either cysteine or lysine for 24 ± 2 h at 25 ± 2.5 °C. Subsequently samples were analysed by HPLC.
For the 100 mM stock solution of the test item precipitation was observed when diluted with the cysteine peptide solution. After the 24 h ± 2 h incubation period but prior to the HPLC analysis samples were inspected for precipitation, turbidity or phase separation. Precipitation was observed for the samples of the test item (including the co-elution control). Samples were centrifuged prior to the HPLC analysis.
For the 100 mM stock solution of the test item precipitation was observed when diluted with the lysine peptide solution. After the 24 h ± 2 h incubation period but prior to the HPLC analysis samples were inspected for precipitation, turbidity or phase separation. Precipitation was observed for the samples of the test item (including the co-elution control). Samples were centrifuged prior to the HPLC analysis. Phase separation was observed for the co-elution control of the positive control sample.
A minor co-elution of the test item with the lysine peptide peak was observed. Therefore, the given peak areas and corresponding peptide values can only be considered as an estimation of the peptide depletion and were not used for evaluation. The 100 mM stock solution of the test item showed minimal reactivity towards the cysteine peptide (0.55%). According to the evaluation criteria in the guideline, if a precipitation or phase separation is observed after the incubation period, peptide depletion may be underestimated and a conclusion on the lack of reactivity cannot be drawn with sufficient confidence in case of a negative result. Due to the observed precipitation in the cysteine experiment no prediction can be made.
The 100 mM stock solution of the positive control (cinnamic aldehyde) showed high reactivity towards the synthetic peptides. The mean depletion of both peptides was 65.38%.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-11-14 to 2018-06-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: KeratinoSens™, EURL ECVAM DB-ALM Protocol No. 155, July 1st, 2015
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of study:
- activation of keratinocytes
- Details on the study design:
- The in vitro KeratinoSens™ assay enables detection of the sensitising potential of a test item by addressing the second molecular key event of the adverse outcome pathway (AOP), namely activation of keratinocytes, by quantifying the luciferase activity in the transgenic cell line KeratinoSens™. The luciferase activity, assessed by luminescence measurement, compared to the respective solvent controls is used to support discrimination between skin sensitisers and non-sensitisers.
- Positive control results:
- The luciferase activity induced by the positive control at a concentration of 64 µM was between 2 and 8 (7.40 (experiment 1); 3.90 (experiment 2) and 3.79 (experiment 3)).
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: luciferase activity
- Value:
- 1.48
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 31.25 µM
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: cell viability [%]
- Value:
- 145.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: EC1.5 [µM]
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: luciferase activity
- Value:
- 1.64
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 15.63 µM
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: cell viability [%]
- Value:
- 108.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: EC1.5 [µM]
- Value:
- 12.25
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Key result
- Run / experiment:
- other: 3
- Parameter:
- other: luciferase activity
- Value:
- 1.45
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: concentration: 42.22 µM
- Key result
- Run / experiment:
- other: 3
- Parameter:
- other: cell viability [%]
- Value:
- 149.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 3
- Parameter:
- other: EC 1.5 [µM]
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- Acceptance Criteria
The test meets acceptance criteria if:
- the luciferase activity induction of the positive control is statistically significant above the threshold of 1.5 (using a t-test) in at least one of the tested concentrations
- the average induction in the three technical replicates for the positive control at a concentration of 64 µM is between 2 and 8
- the EC1.5 value of the positive control is within two standard deviations of the historical mean
- the average coefficient of variation (CV; consisting of 6 wells) of the luminescence reading for the negative (solvent) control DMSO is <20% in each repetition.
The controls fullfilled the validity criteria of the test. - Interpretation of results:
- other: The data generated with this method may be not sufficient to conclude on the absence of skin sensitisation potential of chemicals and should be considered in the context of integrated approach such as IATA.
- Conclusions:
- In this study under the given conditions the test item did not induce the luciferase activity in the transgenic KeratinoSens™ cell line in at least two independent experiment runs. Therefore, the test item can be considered as non sensitiser.
The data generated with this method may be not sufficient to conclude on the absence of skin sensitisation potential of chemicals and should be considered in the context of integrated approach such as IATA. - Executive summary:
In the present study the test material was dissolved in THF. Based on a molecular weight of 348.47 g/mol a stock solution of 200 mM was prepared for experiment 1 and 2. In order to verify the first and second experiment, a third experiment with adapted concentrations was performed. For experiment 3 a stock solution of 10 mM was prepared.
Based on the stock solution a set of twelve master solutions in 100% solvent was prepared by serial dilution using a constant dilution factor of 1:2 for experiment 1 and 2 and a constant dilution factor of 1:1.33 for experiment 3. These master solutions were diluted 1:100 in cell culture medium. The following concentration range was tested in the assay:
Experiment 1 and 2:
2000, 1000, 500, 250, 125, 62.5, 31.25, 15.63, 7.81, 3.91, 1.95, 0.98 µM
Experiment 3:
100, 75.02, 56.28, 42.22, 31.67, 23.76, 17.82, 13.37, 10.03, 7.53, 5.65, 4.24 µM
Cells were incubated with the test item for 48 h at 37°C. After exposure cells were lysed and luciferase activity was assessed by luminescence measurement.
In the first experiment, nosignificant luciferase induction > 1.5 was found in the tested concentration range. Therefore, no EC1.5value could be calculated.
In the second experiment, a max luciferase activity (Imax) induction of 1.64 was determined at a test item concentration of 15.63 µM. The corresponding cell viability was 108.9%. No furthersignificant luciferase induction > 1.5 was found in the tested concentration range.The calculated EC1.5 was < 1000 µM (12.25 µM).
In the third experiment, no significant luciferase induction > 1.5 was found in the tested concentration range. Therefore, no EC1.5 value could be calculated.
No dose response for luciferase activity induction was observed for each individual run as well as for an overall luciferase activity induction.
Under the condition of this study the test item is therefore considered as non sensitiser.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-08-28 to 2018-10-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for Testing of Chemicals, No. 442E: In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation”, adopted 25 June 2018
- Qualifier:
- according to guideline
- Guideline:
- other: Human Cell Line Activation Test (h-CLAT) for Skin Sensitisation, DB-ALM Protocol n°158, July 1st, 2015
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of study:
- activation of dendritic cells
- Details on the study design:
- The in vitro human cell line activation test (h-CLAT) enables detection of the sensitising potential of a test item by addressing the third molecular key event of the adverse outcome pathway (AOP), namely dendritic cell activation, by quantifying the expression of the cell surface markers CD54 and CD86 in the human monocytic cell line THP-1. The expression of the cell surface markers compared to the respective solvent controls is used to support discrimination between skin sensitisers and non-sensitisers.
- Positive control results:
- The positive control (DNCB) led to an upregulation of the expression of CD54 and CD86 in all three experiments. The threshold of 150% for CD86 (242% experiment 1; 351% experiment 2, 370% experiment 3) and 200% for CD54 (251% experiment 1; 252% experiment 2, 292% experiment 3) were clearly exceeded.
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: relative fluorescence intensity CD86 [%]
- Value:
- 132
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 250 µg/mL
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: relative fluorescence intensity CD54 [%]
- Value:
- 117
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 69.77 µg/mL
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: relative fluorescence intensity CD86 [%]
- Value:
- 189
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 208.33 µg/mL
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: relative fluorescence intensity CD54 [%]
- Value:
- 122
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 83.72 µg/mL
- Key result
- Run / experiment:
- other: 3
- Parameter:
- other: relative fluorescence intensity CD86 [%]
- Value:
- 152
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 173.61 µg/mL
- Key result
- Run / experiment:
- other: 3
- Parameter:
- other: relative fluorescence intensity CD54 [%]
- Value:
- 129
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 83.72 µg/mL
- Other effects / acceptance of results:
- Acceptance criteria:
The test meets acceptance criteria if:
• the cell viability of the solvent controls is >90%,
• the cell viability of at least four tested doses of the test item in each run is >50%,
• the RFI values of the positive control (DNCB) is ≥150% for CD86 and ≥200% for CD54 at a cell viability of >50%,
• the RFI values of the solvent control is not ≥150% for CD86 and not ≥200% for CD54,
• the MFI ratio of CD86 and CD54 to isotype IgG1 control for the medium and DMSO control, is >105%.
The test mets the acceptance criteria. - Interpretation of results:
- other: The data generated with this method may be not sufficient to conclude on skin sensitisation potential of chemicals and should be considered in the context of integrated approach such as IATA.
- Conclusions:
- In this study under the given conditions the test item did upregulate the cell surface marker CD86 in at least two independent experiment runs. Therefore, the test item is considered to be a skin sensitiser.
The data generated with this method may be not sufficient to conclude on skin sensitisation potential of chemicals and should be considered in the context of integrated approach such as IATA. - Executive summary:
In the present study the test material was dissolved in THF. For the dose finding assay stock solutions with concentrations ranging from 250 mg/mL to 1.95 mg/mL were prepared by a serial dilution of 1:2. Cells were incubated with the test item for 24 h at 37°C. After exposure cells were stained with propidium iodide and cell viability was measured by FACS analysis.
Due to a lack of cytotoxicity, no CV75 could be derived. Therefore, the main experiment was performed covering the following concentration steps:
500, 416.67, 347.22, 289.35, 241.13, 200.94, 167.45, 139.54 µg/mL
In all experiments precipitation of the test item was observed for all concentration steps when mixing the test item stock solutions with cell culture medium.
Cells were incubated with the test item for 24 h at 37°C. After exposure cells were stained and cell surface markers CD54 and CD86 were measured by FACS analysis. Cell viability was assessed in parallel using propidium iodide staining.
No cytotoxic effects were observed for the cells treated with the test item. Relative cell viability at the highest test item concentration was reduced to 90.3% (CD86), 90.2% (CD54) and 90.0% (isotype IgG1 control) in the first experiment, to 93.5% (CD86), 92.8% (CD54) and 93.8% (isotype IgG1 control) in the second experiment and to 90.7 % (CD86), 94.2 % (CD54) and 93.6 % (isotype IgG1 control) in the third experiment.
The expression of the cell surface marker CD86 was upregulated to 175%, 189%, 172% (250 µg/mL to 173.61 µg/ml) and 154% (69.77 µg/mL) in the second experiment and to 152% (173.61 µg/mL) in the third experiment. In contrast, the expression of the cell surface marker CD54 was not upregulated above the threshold of 200% in any of the experiments.
Since one of the cell surface markers exceeded the threshold in two independent experiments the test item is considered to be a skin sensitiser.
Referenceopen allclose all
Cysteine and Lysine Values of the Calibration Curve
Sample |
Cysteine Peptide |
Lysine Peptide |
||
Peak Area |
Peptide Concentration [mM] |
Peak Area |
Peptide Concentration [mM] |
|
STD1 |
17.8700 |
0.5340 |
4254.6284 |
0.5340 |
STD2 |
9.0120 |
0.2670 |
2161.7087 |
0.2670 |
STD3 |
4.5180 |
0.1335 |
1051.8925 |
0.1335 |
STD4 |
2.2520 |
0.0667 |
525.2503 |
0.0667 |
STD5 |
1.1010 |
0.0334 |
260.5259 |
0.0334 |
STD6 |
0.5300 |
0.0167 |
130.8325 |
0.0167 |
STD7 |
0.0000 |
0.0000 |
0.0000 |
0.0000 |
Depletion of the Cysteine Peptide
Cysteine Peptide |
||||||
Sample |
Peak Area |
Peptide Conc. [mM] |
Peptide Depletion [%] |
Mean Peptide Depletion [%] |
SD of Peptide Depletion [%] |
CV of Peptide Depletion [%] |
Positive Control |
4.4470 |
0.1325 |
74.33 |
74.15 |
0.18 |
0.25 |
4.4770 |
0.1334 |
74.15 |
||||
4.5100 |
0.1344 |
73.96 |
||||
Test Item |
16.9410 |
0.5052 |
0.26 |
0.55 |
0.25 |
46.16 |
16.8690 |
0.5031 |
0.68 |
||||
16.8640 |
0.5029 |
0.71 |
Depletion of the Lysine Peptide
Lysine Peptide |
||||||
Sample |
Peak Area |
Peptide Conc. [mM] |
Peptide Depletion [%] |
Mean Peptide Depletion [%] |
SD of Peptide Depletion [%] |
CV of Peptide Depletion [%] |
Positive Control |
1675.9452 |
0.2100 |
57.93 |
56.62 |
1.13 |
2.00 |
1753.5808 |
0.2197 |
55.98 |
||||
1754.5223 |
0.2198 |
55.95 |
||||
Test Item |
4019.5232 |
0.5032 |
0.26 |
0.37 |
0.13 |
35.68 |
4016.2871 |
0.5028 |
0.34 |
||||
4009.0984 |
0.5019 |
0.52 |
Prediction Model 1
Cysteine 1:10/ Lysine 1:50 Prediction Model 1
Mean Cysteine andLysine PPD |
Reactivity Class |
DPRA Prediction² |
0.00% ≤ PPD ≤ 6.38% |
No or Minimal Reactivity |
Negative |
6.38% < PPD ≤ 22.62% |
Low Reactivity |
Positive |
22.62% < PPD ≤ 42.47% |
Moderate Reactivity |
|
42.47% < PPD ≤ 100% |
High Reactivity |
1 The numbers refer to statistically generated threshold values and are not related to the precision of the measurement.
2 DPRA predictions should be considered in the framework of an IATA.
Prediction Model 2
Cysteine 1:10 Prediction Model
Cysteine PPD |
ReactivityClass |
DPRA Prediction² |
0.00% ≤ PPD ≤ 13.89% |
No or Minimal Reactivity |
Negative |
13.89% < PPD ≤ 23.09% |
Low Reactivity |
Positive |
23.09% < PPD ≤ 98.24% |
Moderate Reactivity |
|
98.24% < PPD ≤ 100% |
High Reactivity |
Categorization of the Test Item
Prediction Model |
Prediction Model 1 |
Prediction Model 2 |
||||
Test Substance |
Mean Peptide Depletion [%] |
Reactivity Category |
Prediction |
Mean Peptide Depletion [%] |
Reactivity Category |
Prediction |
Test Item |
-- |
-- |
-- |
0.55 |
Minimal Reactivity |
negative |
Positive Control |
65.38 |
High Reactivity |
positive |
74.15 |
Moderate Reactivity |
positive |
Cytotoxicity
Results of the Cytotoxicity Measurement
Conc. [µM] |
Cell Viability [%] |
Exp 3 |
|||||
Exp 1 |
Exp 2 |
Mean |
SD |
Conc. [µM] |
Cell Viability [%] |
||
Positive Control |
4.00 |
99.3 |
106.9 |
103.1 |
5.4 |
4.00 |
105.8 |
8.00 |
102.3 |
114.7 |
108.5 |
8.8 |
8.00 |
99.1 |
|
16.00 |
97.6 |
104.6 |
101.1 |
4.9 |
16.00 |
112.3 |
|
32.00 |
97.9 |
113.5 |
105.7 |
11.0 |
32.00 |
118.6 |
|
64.00 |
90.6 |
108.0 |
99.3 |
12.3 |
64.00 |
122.5 |
|
Test Item |
0.98 |
125.0 |
105.9 |
115.5 |
13.6 |
4.24 |
109.1 |
1.95 |
122.3 |
106.7 |
114.5 |
11.0 |
5.65 |
106.3 |
|
3.91 |
138.1 |
103.7 |
120.9 |
24.3 |
7.53 |
101.1 |
|
7.81 |
152.8 |
106.9 |
129.8 |
32.5 |
10.03 |
101.4 |
|
15.63 |
158.4 |
108.9 |
133.7 |
34.9 |
13.37 |
104.4 |
|
31.25 |
145.3 |
81.8 |
113.5 |
44.9 |
17.82 |
99.2 |
|
62.50 |
134.4 |
0.1 |
67.2 |
95.0 |
23.76 |
115.9 |
|
125.00 |
130.2 |
0.2 |
65.2 |
92.0 |
31.67 |
132.4 |
|
250.00 |
122.2 |
0.6 |
61.4 |
86.0 |
42.22 |
149.7 |
|
500.00 |
128.0 |
0.6 |
64.3 |
90.1 |
56.28 |
145.7 |
|
1000.00 |
123.3 |
0.4 |
61.9 |
86.9 |
75.02 |
130.2 |
|
2000.00 |
129.3 |
0.4 |
64.8 |
91.2 |
100.00 |
110.5 |
Conc.: Concentration; Exp: Experiment
Induction of Luciferase Activity Experiment 1
Experiment1 |
Concentration [µM] |
Fold Induction |
Significance |
||||
Rep. 1 |
Rep. 2 |
Rep. 3 |
Mean |
SD |
|||
Positive Control |
4.00 |
1.02 |
1.08 |
1.05 |
1.05 |
0.03 |
|
8.00 |
1.64 |
1.51 |
1.45 |
1.53 |
0.10 |
* |
|
16.00 |
1.61 |
1.80 |
1.84 |
1.75 |
0.12 |
* |
|
32.00 |
3.20 |
3.64 |
4.58 |
3.81 |
0.70 |
* |
|
64.00 |
7.99 |
6.39 |
7.83 |
7.40 |
0.88 |
* |
|
Test Item |
0.98 |
1.20 |
1.17 |
1.16 |
1.18 |
0.02 |
|
1.95 |
1.17 |
1.12 |
1.18 |
1.15 |
0.03 |
|
|
3.91 |
1.25 |
1.29 |
1.33 |
1.29 |
0.04 |
|
|
7.81 |
1.40 |
1.34 |
1.33 |
1.35 |
0.04 |
|
|
15.63 |
1.44 |
1.35 |
1.34 |
1.38 |
0.05 |
|
|
31.25 |
1.68 |
1.38 |
1.39 |
1.48 |
0.17 |
|
|
62.50 |
1.30 |
1.28 |
1.52 |
1.37 |
0.13 |
|
|
125.00 |
1.28 |
1.11 |
1.27 |
1.22 |
0.09 |
|
|
250.00 |
1.14 |
1.20 |
1.08 |
1.14 |
0.06 |
|
|
500.00 |
1.24 |
1.23 |
1.25 |
1.24 |
0.01 |
|
|
1000.00 |
1.22 |
1.18 |
1.07 |
1.16 |
0.08 |
|
|
2000.00 |
1.42 |
1.17 |
1.03 |
1.21 |
0.20 |
|
* = significant induction according to Student’s t-test, p<0.05
Induction of Luciferase Activity Experiment 2
Experiment 2 |
Concentration [µM] |
Fold Induction |
Significance |
||||
Rep. 1 |
Rep. 2 |
Rep. 3 |
Mean |
SD |
|||
Positive Control |
4.00 |
1.22 |
1.16 |
1.04 |
1.14 |
0.09 |
|
8.00 |
1.42 |
1.26 |
1.19 |
1.29 |
0.12 |
|
|
16.00 |
1.64 |
1.74 |
1.56 |
1.65 |
0.09 |
* |
|
32.00 |
1.89 |
2.27 |
2.23 |
2.13 |
0.21 |
* |
|
64.00 |
3.27 |
4.16 |
4.28 |
3.90 |
0.55 |
* |
|
Test Item |
0.98 |
1.30 |
1.27 |
1.35 |
1.30 |
0.04 |
|
1.95 |
1.05 |
1.11 |
1.22 |
1.13 |
0.09 |
|
|
3.91 |
1.36 |
1.36 |
1.19 |
1.30 |
0.10 |
|
|
7.81 |
1.38 |
1.21 |
1.36 |
1.32 |
0.09 |
|
|
15.63 |
1.67 |
1.86 |
1.39 |
1.64 |
0.23 |
* |
|
31.25 |
1.65 |
1.16 |
1.65 |
1.48 |
0.28 |
|
|
62.50 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
|
125.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
|
250.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
|
500.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
|
1000.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
|
2000.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
* = significant induction according to Student’s t-test, p<0.05
Induction of Luciferase Activity Experiment 3
Experiment 3 |
Concentration [µM] |
Fold Induction |
Significance |
||||
Rep. 1 |
Rep. 2 |
Rep. 3 |
Mean |
SD |
|||
Positive Control |
4.00 |
1.21 |
1.28 |
1.49 |
1.32 |
0.15 |
|
8.00 |
1.11 |
1.37 |
1.29 |
1.26 |
0.13 |
|
|
16.00 |
1.15 |
1.44 |
1.35 |
1.32 |
0.15 |
|
|
32.00 |
1.83 |
1.70 |
2.13 |
1.88 |
0.22 |
* |
|
64.00 |
3.77 |
3.63 |
3.97 |
3.79 |
0.17 |
* |
|
Test Item |
4.24 |
1.18 |
1.24 |
1.25 |
1.23 |
0.04 |
|
5.65 |
0.98 |
0.91 |
1.10 |
1.00 |
0.09 |
|
|
7.53 |
1.09 |
1.05 |
1.14 |
1.09 |
0.05 |
|
|
10.03 |
0.86 |
0.91 |
1.09 |
0.95 |
0.12 |
|
|
13.37 |
0.90 |
1.02 |
1.17 |
1.03 |
0.14 |
|
|
17.82 |
0.84 |
0.91 |
1.10 |
0.95 |
0.14 |
|
|
23.76 |
0.98 |
1.12 |
1.19 |
1.10 |
0.11 |
|
|
31.67 |
0.98 |
1.19 |
1.31 |
1.16 |
0.17 |
|
|
42.22 |
1.59 |
1.27 |
1.48 |
1.45 |
0.16 |
|
|
56.28 |
1.33 |
1.44 |
1.54 |
1.44 |
0.11 |
|
|
75.02 |
1.30 |
1.35 |
1.39 |
1.35 |
0.05 |
|
|
100.00 |
1.21 |
1.59 |
1.32 |
1.37 |
0.19 |
|
* = significant induction according to Student’s t-test, p<0.05
Induction of Luciferase Activity – Overall Induction
Conc. [µM] |
Fold Induction |
Exp 3 |
|||||
Exp 1 |
Exp 2 |
Mean |
SD |
Conc. [µM]] |
Fold Induction |
||
Positive Control |
4.00 |
1.05 |
1.14 |
1.09 |
0.06 |
4.00 |
1.32 |
8.00 |
1.53 |
1.29 |
1.41 |
0.17 |
8.00 |
1.26 |
|
16.00 |
1.75 |
1.65 |
1.70 |
0.07 |
16.00 |
1.32 |
|
32.00 |
3.81 |
2.13 |
2.97 |
1.18 |
32.00 |
1.88 |
|
64.00 |
7.40 |
3.90 |
5.65 |
2.47 |
64.00 |
3.79 |
|
Test Item |
0.98 |
1.18 |
1.30 |
1.24 |
0.09 |
4.24 |
1.23 |
1.95 |
1.15 |
1.13 |
1.14 |
0.02 |
5.65 |
1.00 |
|
3.91 |
1.29 |
1.30 |
1.30 |
0.01 |
7.53 |
1.09 |
|
7.81 |
1.35 |
1.32 |
1.34 |
0.03 |
10.03 |
0.95 |
|
15.63 |
1.38 |
1.64 |
1.51 |
0.19 |
13.37 |
1.03 |
|
31.25 |
1.48 |
1.48 |
1.48 |
0.00 |
17.82 |
0.95 |
|
62.50 |
1.37 |
0.00 |
0.68 |
0.97 |
23.76 |
1.10 |
|
125.00 |
1.22 |
0.00 |
0.61 |
0.86 |
31.67 |
1.16 |
|
250.00 |
1.14 |
0.00 |
0.57 |
0.81 |
42.22 |
1.45 |
|
500.00 |
1.24 |
0.00 |
0.62 |
0.88 |
56.28 |
1.44 |
|
1000.00 |
1.16 |
0.00 |
0.58 |
0.82 |
75.02 |
1.35 |
|
2000.00 |
1.21 |
0.00 |
0.60 |
0.86 |
100.00 |
1.37 |
Conc.: Concentration; Exp: Experiment
Additional Parameters
Parameter |
Exp. 1 |
Exp. 2 |
Exp. 3 |
Mean |
SD |
EC1.5[µM] |
n.a. |
12.25 |
n.a. |
12.25 |
- |
Imax |
1.48 |
1.64 |
1.45 |
1.52 |
0.10 |
IC30[µM] |
n.a. |
35.75 |
n.a. |
35.75 |
- |
IC50[µM] |
n.a. |
43.40 |
n.a. |
43.40 |
- |
Exp: Experiment; n.a.: not applicable
Acceptance Criteria
Criterion |
Range |
Exp 1 |
pass/fail |
Exp 2 |
pass/fail |
Exp 3 |
pass/fail |
|
CV DMSO Solvent Control |
< 20% |
10.3 |
pass |
11.5 |
pass |
9.3 |
pass |
|
CV THF Solvent Control |
|
10.3 |
pass |
15.0 |
pass |
9.6 |
pass |
|
No. of PC concentration steps with significant luciferase activity induction >1.5 |
≥ 1 |
4.0 |
pass |
3.0 |
pass |
2.0 |
pass |
|
EC1.5 PC |
7 < x < 34 µM |
7.72 |
pass |
12.71 |
pass |
21.19 |
pass |
|
Induction PC at 64 µM |
2.00 < x < 8.00 |
7.40 |
pass |
3.90 |
pass |
3.79 |
pass |
|
Exp: Experiment
Historical Data
Acceptance Criterion |
Range |
Mean |
SD |
N |
CV Solvent Control |
< 20% |
11.3 |
3.3 |
41 |
No. of positive control concentration steps with significant luciferase activity induction >1.5 |
≥ 1 |
2.3 |
0.6 |
41 |
EC1.5 PC |
7 < x < 34 µM |
20.4 |
6.7 |
41 |
Induction PC at 64 µM |
2.00 < x < 8.00 |
3.3 |
1.1 |
41 |
Results of the Cell Batch Activation Test (Batch 1)
Sample |
Concentration |
CD86 |
CD54 |
Activated |
Pass /Fail |
||||
Cell Viability [%] |
RFI |
Threshold OECD TG 442E |
Cell Viability [%] |
RFI |
Threshold OECD TG 442E |
yes/no |
|||
DNCB |
4 µg/mL |
87.5 |
373 |
>150 |
88.1 |
358 |
>200 |
yes |
pass |
NiSO4 |
100 µg/mL |
83.5 |
295 |
>150 |
82.1 |
603 |
>200 |
yes |
pass |
LA |
1000 µg/mL |
95.7 |
81 |
≤150 |
95.8 |
100 |
≤200 |
no |
pass |
Results of the Cell Batch Activation Test (Batch 2)
Sample |
Concentration |
CD86 |
CD54 |
Activated |
Pass /Fail |
||||
Cell Viability [%] |
RFI |
Threshold OECD TG 442E |
Cell Viability [%] |
RFI |
Threshold OECD TG 442E |
yes/no |
|||
DNCB |
4 µg/mL |
83.4 |
364 |
>150 |
82.3 |
419 |
>200 |
yes |
pass |
NiSO4 |
100 µg/mL |
79.1 |
351 |
>150 |
77.9 |
688 |
>200 |
yes |
pass |
LA |
1000 µg/mL |
96.2 |
77 |
≤150 |
95.9 |
105 |
≤200 |
no |
pass |
Results of the Dose Finding Assay
Sample |
Experiment 1 |
||
Concentration applied [µg/mL] |
Cell Viability [%] |
||
Medium Control |
-- |
-- |
93.40 |
Solvent Control |
THF |
-- |
95.10 |
Test item |
C8 |
3.91 |
95.30 |
C7 |
7.81 |
95.60 |
|
C6 |
15.63 |
96.10 |
|
C5 |
31.25 |
96.30 |
|
C4 |
62.50 |
94.90 |
|
C3 |
125.00 |
95.50 |
|
C2 |
250.00 |
94.90 |
|
C1 |
500.00 |
94.70 |
|
Calculated CV75 [µg/mL] |
No CV75 |
||
Mean CV75 [µg/mL] |
No CV75 |
||
SD CV 75 [µg/mL] |
No SD |
CD54 and CD86 Expression Experiment 1
Sample |
Conc. |
Cell Viability [%] |
Mean Fluorescence Intensity |
corrected Mean Fluorescence Intensity |
Relative Flourescence Intensity (RFI) |
Ratio Isotype IgG1 to [%] |
|||||||
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
CD86 |
CD54 |
CD86 |
CD54 |
||
Medium Control |
- |
93.2 |
93.6 |
92.5 |
3139 |
1213 |
684 |
2455 |
529 |
92 |
92 |
459 |
177 |
Solvent Control 2 (THF) |
0.20% |
92.6 |
93.2 |
92.7 |
3075.0 |
1289.0 |
714.0 |
2361 |
575 |
100 |
100 |
431 |
181 |
Solvent Control 1 (DMSO) |
0.20% |
92.5 |
91.9 |
91.9 |
3337 |
1245 |
668 |
2669 |
577 |
100 |
100 |
500 |
186 |
DNCB |
4.00 |
78.9 |
79.2 |
78.5 |
7147 |
2123 |
675 |
6472 |
1448 |
242 |
251 |
1059 |
315 |
Test item |
250 |
90.3 |
90.2 |
90.0 |
3884 |
1414 |
776 |
3108 |
638 |
132 |
111 |
501 |
182 |
208.33 |
91.5 |
91.3 |
91.1 |
3527 |
1378 |
771 |
2756 |
607 |
117 |
106 |
457 |
179 |
|
173.61 |
90.3 |
90.4 |
90.3 |
3652 |
1377 |
790 |
2862 |
587 |
121 |
102 |
462 |
174 |
|
144.68 |
91.1 |
92.1 |
91.7 |
3541 |
1454 |
785 |
2756 |
669 |
117 |
116 |
451 |
185 |
|
120.56 |
91.7 |
91.4 |
91.5 |
3194 |
1359 |
767 |
2427 |
592 |
103 |
103 |
416 |
177 |
|
100.47 |
92.1 |
91.6 |
90.8 |
3326 |
1424 |
775 |
2551 |
649 |
108 |
113 |
429 |
184 |
|
83.72 |
91.7 |
91.6 |
91.3 |
3276 |
1398 |
991 |
2285 |
407 |
97 |
71 |
331 |
141 |
|
69.77 |
91.5 |
92.0 |
91.3 |
3403 |
1448 |
778 |
2625 |
670 |
111 |
117 |
437 |
186 |
CD54 and CD86 Expression Experiment 2
Sample |
Conc. |
Cell Viability [%] |
Mean Fluorescence Intensity |
corrected Mean Fluorescence Intensity |
Relative Flourescence Intensity (RFI) |
Ratio Isotype IgG1 to [%] |
|||||||
CD86 |
CD54 |
IgG Isotype |
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
CD86 |
CD54 |
C86 |
CD54 |
||
Medium Control |
- |
95.2 |
95.2 |
94.3 |
2540 |
1237 |
551 |
1989 |
686 |
90 |
113 |
461 |
225 |
Solvent Control 2 (THF) |
0.20% |
95.3 |
95.0 |
94.8 |
2264 |
1220 |
595 |
1669 |
625 |
100 |
100 |
381 |
205 |
Solvent Control 1 (DMSO) |
0.20% |
95.4 |
94.9 |
94.3 |
2777 |
1168 |
562 |
2215 |
606 |
100 |
100 |
494 |
208 |
DNCB |
4.0 |
77.0 |
77.2 |
75.8 |
8350 |
2099 |
569 |
7781 |
1530 |
351 |
252 |
1467 |
369 |
Test item |
250.00 |
93.50 |
92.80 |
93.80 |
3571 |
1335 |
643 |
2928 |
692 |
175 |
111 |
555 |
208 |
208.33 |
92.40 |
92.10 |
93.00 |
3818 |
1267 |
666 |
3152 |
601 |
189 |
96 |
573 |
190 |
|
173.61 |
93.00 |
93.50 |
92.90 |
3513 |
1356 |
648 |
2865 |
708 |
172 |
113 |
542 |
209 |
|
144.68 |
92.90 |
92.70 |
92.80 |
2847 |
1275 |
655 |
2192 |
620 |
131 |
99 |
435 |
195 |
|
120.56 |
94.10 |
94.40 |
93.10 |
2766 |
1306 |
662 |
2104 |
644 |
126 |
103 |
418 |
197 |
|
100.47 |
94.10 |
93.40 |
92.90 |
2712 |
1103 |
658 |
2054 |
445 |
123 |
71 |
412 |
168 |
|
83.72 |
94.40 |
94.60 |
94.70 |
2453 |
1396 |
633 |
1820 |
763 |
109 |
122 |
388 |
221 |
|
69.77 |
93.40 |
93.20 |
93.00 |
3221 |
1353 |
656 |
2565 |
697 |
154 |
112 |
491 |
206 |
CD54 and CD86 Expression Experiment 3
Sample |
Conc. |
Cell Viability [%] |
Mean Fluorescence Intensity |
corrected Mean Fluorescence Intensity |
Relative Flourescence Intensity (RFI) |
Ratio Isotype IgG1 to [%] |
|||||||
CD86 |
CD54 |
IgG Isotype |
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
CD86 |
CD54 |
C86 |
CD54 |
||
Medium Control |
- |
95.2 |
94.9 |
94.6 |
1666 |
937 |
628 |
1038 |
309 |
85 |
65 |
265 |
149 |
Solvent Control 2 (THF) |
0.20% |
96.5 |
95.8 |
95.9 |
1689 |
911 |
504 |
1185 |
407 |
100 |
100 |
335 |
181 |
Solvent Control 1 (DMSO) |
0.20% |
95.2 |
95.2 |
95.1 |
1713 |
971 |
496 |
1217 |
475 |
100 |
100 |
345 |
196 |
DNCB |
4.0 |
83.3 |
84.2 |
84.4 |
5085 |
1972 |
586 |
4499 |
1386 |
370 |
292 |
868 |
337 |
Test item |
250.0 |
90.7 |
94.2 |
93.6 |
2174 |
1034 |
568 |
1606 |
466 |
136 |
115 |
383 |
182 |
208.33 |
93.7 |
93.2 |
92.3 |
2184 |
989 |
573 |
1611 |
416 |
136 |
102 |
381 |
173 |
|
173.61 |
92.8 |
92.0 |
92.5 |
2415 |
1069 |
618 |
1797 |
451 |
152 |
111 |
391 |
173 |
|
144.68 |
93.8 |
93.5 |
93.2 |
2261 |
960 |
576 |
1685 |
384 |
142 |
94 |
393 |
167 |
|
120.56 |
94.2 |
94.2 |
93.7 |
2080 |
1004 |
553 |
1527 |
451 |
129 |
111 |
376 |
182 |
|
100.47 |
93.5 |
93.5 |
93.5 |
2108 |
1016 |
567 |
1541 |
449 |
130 |
110 |
372 |
179 |
|
83.72 |
93.4 |
94.1 |
94.1 |
2169 |
1098 |
575 |
1594 |
523 |
135 |
129 |
377 |
191 |
|
69.77 |
94.4 |
94.6 |
94.0 |
2087 |
1075 |
593 |
1494 |
482 |
126 |
118 |
352 |
181 |
Acceptance Criteria
Acceptance Criterion |
Range |
Exp. 1 |
pass/fail |
Exp. 2 |
pass/fail |
Exp. 3 |
pass/fail |
||||||
cell viability solvent controls [%] |
>90 |
91.9 |
- |
93.6 |
pass |
94.3 |
- |
95.4 |
pass |
94.6 |
- |
96.5 |
pass |
number of test dosed with viability >50% CD86 |
≥4 |
8 |
pass |
8 |
pass |
8 |
pass |
||||||
number of test dosed with viability >50% CD54 |
≥4 |
8 |
pass |
8 |
pass |
8 |
pass |
||||||
number of test dosed with viability >50% IgG1 |
≥4 |
8 |
pass |
8 |
pass |
8 |
pass |
||||||
RFI of positive control of CD86 |
≥150 |
242 |
pass |
351 |
pass |
370 |
pass |
||||||
RFI of positive control of CD54 |
≥200 |
251 |
pass |
252 |
pass |
292 |
pass |
||||||
RFI of DMSO solvent control of CD86 |
<150 |
109 |
pass |
111 |
pass |
117 |
pass |
||||||
RFI of DMSO solvent control of CD54 |
<200 |
109 |
pass |
88 |
pass |
154 |
pass |
||||||
RFI of THF solvent control of CD86 |
<150 |
96 |
pass |
84 |
pass |
114 |
pass |
||||||
RFI of THF solvent control of CD54 |
<200 |
109 |
pass |
91 |
pass |
132 |
pass |
||||||
MFI ratio CD86/IgG1 for medium control [%] |
>105 |
459 |
pass |
461 |
pass |
265 |
pass |
||||||
MFI ratio CD86/IgG1 for DMSO control [%] |
>105 |
500 |
pass |
494 |
pass |
345 |
pass |
||||||
MFI ratio CD86/IgG1 for THF control [%] |
>105 |
431 |
pass |
381 |
pass |
335 |
pass |
||||||
MFI ratio CD54/IgG1for medium control [%] |
>105 |
177 |
pass |
225 |
pass |
149 |
pass |
||||||
MFI ratio CD54/IgG1for DMSO control [%] |
>105 |
186 |
pass |
208 |
pass |
196 |
pass |
||||||
MFI ratio CD54/IgG1 for THF control [%] |
>105 |
181 |
pass |
205 |
pass |
181 |
pass |
Historical Data
Criterion |
mean |
SD |
N |
cell viability solvent controls [%] |
96.2 |
1.6 |
216 |
number of test doses with viability >50% |
- |
- |
555 |
RFI of positive control of CD86 |
358.9 |
90.1 |
36 |
RFI of positive control of CD54 |
435.7 |
285.8 |
36 |
RFI of solvent control (THF) of CD86 |
102.9 |
17.4 |
36 |
RFI of solvent control (THF) of CD54 |
102.0 |
15.4 |
36 |
MFI ratio IgG1/CD86 for medium control [%] |
285.6 |
124.3 |
36 |
MFI ratio IgG1/CD86 for THF control [%] |
270.8 |
105.0 |
36 |
MFI ratio IgG1/CD54 for medium control [%] |
308.6 |
137.1 |
36 |
MFI ratio IgG1/CD54 for THF control [%] |
158.2 |
28.4 |
36 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The provided information indicates need for classification for skin sensitisation class 1 according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures, as amended for the 10th time in Regulation (EU) No 2017/ 776.
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