Registration Dossier
Registration Dossier
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EC number: 807-350-0 | CAS number: 1161009-88-6
Endpoint summary
Administrative data
Description of key information
in vitro data:
OECD 442C:
In preparation of the OECD 442 assay, solubility testing in the solvents used for the OECD 422 C assay was performed. The test item solubility was studied in acetonitrile, water, isopropanol, methanol, and ethanol. In the solubility testing no test item solvent compatible with the DPRA was found. Therefore, the study cannot be performed.
OECD 442D: positive
OECD 442E:
In this study under the given conditions the test item did not upregulate the expression of the cell surface marker in at least two independent experiment runs. Therefore the test item considered to be no skin sensitiser. Due to the high logP of the substance (> 6.5) the negative result should not be considered (cf. OECD 442E).
in vivo data:
OECD 429:
Test material formulations in DMF at concentrations between 25 and 0.5 % showed systemic and local effects including body weight loss, reduced activity, ear swelling, increased ear weight, scaly skin and eschar formation. The local effects were present even at a low dose of 0.5 %. Therefore, the main test was cancelled due to these technical difficulties and no conclusion on skin sensitisation potential can be derived
QSAR:
negative no structural alerts. no unknown structural features
Exposure
Below dermal sensitisation threshold. Margin of safety for skin sensitisation: 10000 (non reactive), 384 (reactive)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- Expert Judgement
- Type of information:
- other: Expert Judgement
- Adequacy of study:
- other information
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Please refer to the justification in the field "attached full study report".
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- A weight of evidence approach was used to obtain sufficient information on the skin sensitisation potential of this compound. For this compound evidence was accumulated from exposure assessment, from the chemical reactivity analysis of the molecule and from responses obtained in in vitro or in vivo assays addressing key events of the biological mechanism associated with sensitisation.
- GLP compliance:
- no
- Type of study:
- other: Expert Judgement
- Reading:
- other: overall
- No. with + reactions:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The absence of structural alerts, the in vitro battery results and the exposure assessment provide sufficient evidence to conclude that for the test material there is no safety concern for skin sensitisation.
- Endpoint:
- skin sensitisation, other
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: ECHA Guidance QSAR
- GLP compliance:
- no
- Run / experiment:
- other: 1
- Parameter:
- other:
- Value:
- 0
- Vehicle controls validity:
- not examined
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: The result must be considered in the context of an integrated approach.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2017-02-10 to 2017-04-07
- 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 (2.83 in experiment 1; 2.67 in experiment 2).
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: luciferase activity
- Value:
- 13.17
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: cell viability [%]
- Value:
- 208.2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: EC1.5 [µM]
- Value:
- 2.41
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: luciferase activity
- Value:
- 9.01
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: cell viability [%]
- Value:
- 143.9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: EC1.5 [µM]
- Value:
- 2.56
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- 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 result must be considered in the context of an integrated approach.
- Conclusions:
- In this study under the given conditions the test item did induce the luciferase activity in the transgenic KeratinoSens™ cell line in at least two independent experiment runs. Therefore, the test item can be considered to be a sensitiser in accordance with UN GHS category 1.
- Executive summary:
In the present study the test material was dissolved in DMSO.
Based on a molecular weight of 395 g/mol a stock solution of 200 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. These master solutions were diluted 1:100 in cell culture medium. The following concentration range was tested in the assay:
2000, 1000, 500, 250, 125, 62.5, 31.25, 15.63, 7.81, 3.91, 1.95, 0.98 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, a max luciferase activity (Imax) induction of 13.17 was determined at a test item concentration of 31.25 µM. The corresponding cell viability was 208.2%. The lowest tested concentration with a significant luciferase induction >1.5 (2.70) was found to be 3.91 µM. The corresponding cell viability was >70% (202.9%). The calculated EC1.5was < 1000 µM (2.41 µM). Microscopically, signs of precipitates were observed at the 4 highest test item concentrations.This may be the reason for the decrease in luciferase activity at the highest test item concentrations.
In the second experiment, a max luciferase activity (Imax) induction of 9.01 was determined at a test item concentration of 125.0 µM. The corresponding cell viability was 143.9%. The lowest tested concentration with a significant luciferase induction >1.5 (2.22) was found to be 3.91 µM. The corresponding cell viability was >70% (139.1%). The calculated EC1.5was < 1000 µM (2.56 µM). Microscopically, signs of precipitates were observed at the 4 highest test item concentrations. This may be the reason for the decrease in luciferase activity at the highest test item concentrations.
A 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 sensitiser.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2017-09-15 to 2018-01-19
- 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: human Cell Line Activation Test (h-CLAT)” adopted 29 July 2016
- 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 both experiments. The threshold of 150% for CD86 (352% experiment 1; 288% experiment 2) and 200% for CD54 (248% experiment 1; 286% experiment 2) were clearly exceeded
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: relative fluorescence intensity CD86 [%]
- Value:
- 143
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 334.90 µM
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: relative fluorescence intensity CD54 [%]
- Value:
- 95
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 334.90 µM
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: relative fluorescence intensity CD86 [%]
- Value:
- 149
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 833.33 µM
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: relative fluorescence intensity CD54 [%]
- Value:
- 93
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 694.44 µM
- 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 result must be considered in the context of an integrated approach.
- Conclusions:
- In this study under the given conditions the test item did not upregulate the expression of the cell surface marker in at least two independent experiment runs. Therefore the test item considered to be no skin sensitiser. Due to the high logP of the substance (> 6.5) the negative result should not be considered (cf. OECD 442E).
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. For the dose finding assay stock solutions with concentrations ranging from 500 mg/mL to 3.91 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:
1000; 833.33, 694.44, 578.70, 482.25, 401.88, 334.90, 279.08 µg/mL
In both experiments precipitation of the test item was observed when mixing the test item stock solutions (prepared in THF) 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 95.7% (CD86), 94.7% (CD54) and 94.9% (isotype IgG1 control) in the first experiment and to 97.00% (CD86), 96.90% (CD54) and 96.90% (isotype IgG1 control) in the second experiment.
The expression of the cell surface marker CD86 was not upregulated above the threshold of 150% in any of the experiments. The expression of cell surface marker CD54 was not upregulated above the threshold of 200% in any of the experiments. Therefore, the test item is considered to be no skin sensitiser.
The positive control (DNCB) led to an upregulation of the expression of CD54 and CD86 in both experiments. The threshold of 150% for CD86 (352% experiment 1; 288% experiment 2) and 200% for CD54 (248% experiment 1; 286% experiment 2) were clearly exceeded.
In this study under the given conditions the test item did not upregulate the expression of the cell surface marker in at least two independent experiment runs. Therefore the test item considered to be no skin sensitiser. Due to the high logP of the substance (> 6.5) the negative result should not be considered (cf. OECD 442E).
Referenceopen allclose all
Table1: Results of the Cytotoxicity Measurement
|
Concentration [µM] |
Cell Viability [%] |
|||
Experiment 1 |
Experiment 2 |
Mean |
SD |
||
Solvent Control |
- |
100 |
100 |
100 |
0.0 |
Positive Control |
4.00 |
100.4 |
111.4 |
105.9 |
7.8 |
8.00 |
102.2 |
109.0 |
105.6 |
4.9 |
|
16.00 |
116.3 |
109.7 |
113.0 |
4.6 |
|
32.00 |
117.7 |
115.0 |
116.3 |
1.8 |
|
64.00 |
129.4 |
123.2 |
126.3 |
4.4 |
|
Test Item |
0.98 |
143.4 |
109.1 |
126.2 |
24.3 |
1.95 |
153.7 |
113.5 |
133.6 |
28.4 |
|
3.91 |
202.9 |
139.1 |
171.0 |
45.1 |
|
7.81 |
206.8 |
136.7 |
171.7 |
49.6 |
|
15.63 |
203.6 |
141.3 |
172.5 |
44.1 |
|
31.25 |
208.2 |
137.5 |
172.8 |
50.0 |
|
62.50 |
205.9 |
140.7 |
173.3 |
46.1 |
|
125.00 |
217.7 |
143.9 |
180.8 |
52.2 |
|
250.00 |
208.3 |
143.4 |
175.9 |
45.9 |
|
500.00 |
210.1 |
144.3 |
177.2 |
46.6 |
|
1000.00 |
191.9 |
138.6 |
165.2 |
37.7 |
|
2000.00 |
198.0 |
129.2 |
163.6 |
48.7 |
|
Table2: Induction of Luciferase Activity Experiment 1
Experiment 1 |
Concentration [µM] |
Fold Induction |
Significance |
||||
Rep. 1 |
Rep. 2 |
Rep. 3 |
Mean |
SD |
|||
Solvent Control |
- |
1.00 |
1.00 |
1.00 |
1.00 |
0.00 |
|
Positive Control |
4.00 |
1.20 |
1.20 |
1.22 |
1.21 |
0.01 |
|
8.00 |
1.20 |
1.23 |
1.29 |
1.24 |
0.05 |
|
|
16.00 |
1.30 |
1.25 |
1.56 |
1.37 |
0.17 |
|
|
32.00 |
1.86 |
1.58 |
2.28 |
1.90 |
0.35 |
* |
|
64.00 |
2.86 |
2.81 |
2.81 |
2.83 |
0.03 |
* |
|
Test Item |
0.98 |
1.16 |
1.14 |
1.12 |
1.14 |
0.02 |
|
1.95 |
1.20 |
0.98 |
1.22 |
1.14 |
0.14 |
|
|
3.91 |
2.38 |
2.73 |
2.99 |
2.70 |
0.31 |
* |
|
7.81 |
11.91 |
8.86 |
11.80 |
10.86 |
1.73 |
* |
|
15.63 |
13.08 |
10.89 |
12.28 |
12.08 |
1.11 |
* |
|
31.25 |
14.54 |
11.62 |
13.36 |
13.17 |
1.47 |
* |
|
62.50 |
12.97 |
11.71 |
13.08 |
12.58 |
0.76 |
* |
|
125.00 |
14.70 |
10.24 |
13.51 |
12.82 |
2.31 |
* |
|
250.00 |
11.87 |
9.37 |
11.35 |
10.86 |
1.32 |
* |
|
500.00 |
10.34 |
9.06 |
11.72 |
10.37 |
1.33 |
* |
|
1000.00 |
9.14 |
7.65 |
9.33 |
8.71 |
0.92 |
* |
|
2000.00 |
4.97 |
5.52 |
7.25 |
5.91 |
1.19 |
* |
|
* = significant induction according to Student’s t-test, p<0.05
Table3: Induction of Luciferase Activity Experiment 2
Experiment 2 |
Concentration [µM] |
Fold Induction |
Significance |
||||
Rep. 1 |
Rep. 2 |
Rep. 3 |
Mean |
SD |
|||
Solvent Control |
- |
1.00 |
1.00 |
1.00 |
1.00 |
0.00 |
|
Positive Control |
4.00 |
1.00 |
1.19 |
1.44 |
1.21 |
0.22 |
|
8.00 |
1.32 |
1.22 |
1.28 |
1.27 |
0.05 |
|
|
16.00 |
1.34 |
1.62 |
1.34 |
1.43 |
0.16 |
|
|
32.00 |
1.61 |
2.16 |
1.56 |
1.78 |
0.33 |
|
|
64.00 |
3.06 |
2.85 |
2.11 |
2.67 |
0.50 |
* |
|
Test Item |
0.98 |
1.07 |
1.06 |
1.16 |
1.10 |
0.05 |
|
1.95 |
1.24 |
1.12 |
1.16 |
1.17 |
0.06 |
|
|
3.91 |
1.91 |
2.74 |
2.01 |
2.22 |
0.45 |
* |
|
7.81 |
7.92 |
8.46 |
7.20 |
7.86 |
0.63 |
* |
|
15.63 |
8.14 |
8.75 |
7.57 |
8.15 |
0.59 |
* |
|
31.25 |
8.72 |
9.63 |
8.39 |
8.92 |
0.64 |
* |
|
62.50 |
9.36 |
9.19 |
8.14 |
8.90 |
0.66 |
* |
|
125.00 |
9.41 |
9.58 |
8.05 |
9.01 |
0.84 |
* |
|
250.00 |
8.17 |
7.68 |
6.62 |
7.49 |
0.79 |
* |
|
500.00 |
8.26 |
6.90 |
6.52 |
7.23 |
0.92 |
* |
|
1000.00 |
6.67 |
4.98 |
4.93 |
5.53 |
0.99 |
* |
|
2000.00 |
4.98 |
3.57 |
5.50 |
4.68 |
1.00 |
* |
|
* = significant induction according to Student’s t-test, p<0.05
Table4: Induction of Luciferase Activity – Overall Induction
|
Concentration [µM] |
Fold Induction |
Significance |
|||
Experiment 1 |
Experiment 2 |
Mean |
SD |
|||
Solvent Control |
- |
1.00 |
1.00 |
1.00 |
0.00 |
|
Positive Control |
4.00 |
1.21 |
1.21 |
1.21 |
0.00 |
|
8.00 |
1.24 |
1.27 |
1.26 |
0.02 |
|
|
16.00 |
1.37 |
1.43 |
1.40 |
0.05 |
|
|
32.00 |
1.90 |
1.78 |
1.84 |
0.09 |
* |
|
64.00 |
2.83 |
2.67 |
2.75 |
0.11 |
* |
|
Test Item |
0.98 |
1.14 |
1.10 |
1.12 |
0.03 |
|
1.95 |
1.14 |
1.17 |
1.15 |
0.03 |
|
|
3.91 |
2.70 |
2.22 |
2.46 |
0.34 |
* |
|
7.81 |
10.86 |
7.86 |
9.36 |
2.12 |
* |
|
15.63 |
12.08 |
8.15 |
10.12 |
2.78 |
* |
|
31.25 |
13.17 |
8.92 |
11.05 |
3.01 |
* |
|
62.50 |
12.58 |
8.90 |
10.74 |
2.61 |
* |
|
125.00 |
12.82 |
9.01 |
10.92 |
2.69 |
* |
|
250.00 |
10.86 |
7.49 |
9.18 |
2.38 |
* |
|
500.00 |
10.37 |
7.23 |
8.80 |
2.23 |
* |
|
1000.00 |
8.71 |
5.53 |
7.12 |
2.25 |
|
|
2000.00 |
5.91 |
4.68 |
5.30 |
0.87 |
* |
|
* = significant induction according to Student’s t-test, p<0.05
Results of the Dose Finding Assay
Sample |
Experiment 1 |
|
Concentration applied [µg/ml] |
Cell Viability [%] |
|
Medium Control |
0.00 |
95.50 |
Solvent Control (0.2% THF (v/v)) |
0.00 |
95.30 |
Test Item |
7.81 |
96.00 |
15.63 |
96.30 |
|
31.25 |
95.80 |
|
62.50 |
95.90 |
|
125.00 |
94.90 |
|
250.00 |
95.50 |
|
500.00 |
94.70 |
|
1000.00 |
93.00 |
|
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 |
- |
97.3 |
97.5 |
97.1 |
1173 |
892 |
571 |
602 |
321 |
99 |
90 |
205 |
156 |
Solvent Control THF |
0.20% |
97.1 |
97.2 |
97.3 |
1117.0 |
893.0 |
562.0 |
555 |
331 |
100 |
100 |
199 |
159 |
Solvent Control DMSO |
0.20% |
97.2 |
97.1 |
97.4 |
1181 |
930 |
575 |
606 |
355 |
100 |
100 |
205 |
162 |
DNCB |
4.00 |
87.1 |
86.5 |
85.6 |
2736 |
1481 |
600 |
2136 |
881 |
352 |
248 |
456 |
247 |
Test Item |
1000 |
95.7 |
94.7 |
94.9 |
1280 |
811 |
547 |
733 |
264 |
132 |
80 |
234 |
148 |
833.33 |
95.6 |
95.6 |
95.3 |
1280 |
818 |
545 |
735 |
273 |
132 |
82 |
235 |
150 |
|
694.44 |
96.3 |
96.3 |
96.8 |
1237 |
804 |
532 |
705 |
272 |
127 |
82 |
233 |
151 |
|
578.70 |
96.1 |
96.5 |
96.5 |
1280 |
807 |
550 |
730 |
257 |
132 |
78 |
233 |
147 |
|
482.25 |
96.4 |
96.1 |
95.9 |
1225 |
794 |
559 |
666 |
235 |
120 |
71 |
219 |
142 |
|
401.88 |
97.0 |
97.0 |
96.9 |
1114 |
840 |
536 |
578 |
304 |
104 |
92 |
208 |
157 |
|
334.90 |
97.0 |
96.8 |
96.8 |
1304 |
824 |
510 |
794 |
314 |
143 |
95 |
256 |
162 |
|
279.08 |
96.9 |
96.4 |
97.0 |
1178 |
798 |
527 |
651 |
271 |
117 |
82 |
224 |
151 |
|
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 |
Isotype IgG1 |
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
CD86 |
CD54 |
C86 |
CD54 |
||
Medium Control |
- |
98.1 |
97.7 |
97.6 |
2058 |
1077 |
672 |
1386 |
405 |
77 |
81 |
306 |
160 |
Solvent Control 2 |
0.20% |
97.6 |
97.6 |
97.3 |
2026 |
1078 |
652 |
1374 |
426 |
100 |
100 |
311 |
165 |
Solvent Control 1 |
0.20% |
97.4 |
97.8 |
97.4 |
2490 |
1179 |
682 |
1808 |
497 |
100 |
100 |
365 |
173 |
DNCB |
4.0 |
86.0 |
85.3 |
85.7 |
5888 |
2108 |
688 |
5200 |
1420 |
288 |
286 |
856 |
306 |
Test item |
1000.00 |
97.0 |
96.9 |
96.9 |
2471 |
917 |
618 |
1853 |
299 |
135 |
70 |
400 |
148 |
833.33 |
96.9 |
96.9 |
97.0 |
2667 |
976 |
621 |
2046 |
355 |
149 |
83 |
429 |
157 |
|
694.44 |
97.2 |
96.9 |
97.0 |
2431 |
1039 |
644 |
1787 |
395 |
130 |
93 |
377 |
161 |
|
578.70 |
97.9 |
97.7 |
97.9 |
2276 |
1030 |
662 |
1614 |
368 |
117 |
86 |
344 |
156 |
|
482.25 |
97.7 |
97.6 |
97.8 |
2347 |
1036 |
639 |
1708 |
397 |
124 |
93 |
367 |
162 |
|
401.88 |
97.4 |
97.0 |
96.5 |
2374 |
1032 |
658 |
1716 |
374 |
125 |
88 |
361 |
157 |
|
334.90 |
97.7 |
97.1 |
97.2 |
2172 |
1036 |
691 |
1481 |
345 |
108 |
81 |
314 |
150 |
|
279.08 |
97.7 |
98.0 |
97.5 |
2273 |
1010 |
679 |
1594 |
331 |
116 |
78 |
335 |
149 |
|
Acceptance Criteria
Acceptance Criterion |
range |
Experiment 1 |
pass/fail |
Experiment 2 |
pass/fail |
||||
cell viability medium and solvent controls [%] |
>90 |
97.1 |
- |
97.5 |
pass |
97.3 |
- |
98.1 |
pass |
number of test dosed with viability >50% CD86 |
≥4 |
8 |
pass |
8 |
pass |
||||
number of test dosed with viability >50% CD54 |
≥4 |
8 |
pass |
8 |
pass |
||||
number of test dosed with viability >50% IgG1 |
≥4 |
8 |
pass |
8 |
pass |
||||
RFI of positive control of CD86 |
≥150 |
352 |
pass |
288 |
pass |
||||
RFI of positive control of CD54 |
≥200 |
248 |
pass |
286 |
pass |
||||
RFI of solvent control of CD86 |
<150 |
101 |
pass |
130 |
pass |
||||
RFI of solvent control of CD54 |
<200 |
111 |
pass |
123 |
pass |
||||
MFI ratio IgG1/CD86 for medium control [%] |
>105 |
205 |
pass |
306 |
pass |
||||
MFI ratio IgG1/CD86 for DMSO control [%] |
>105 |
205 |
pass |
365 |
pass |
||||
MFI ratio IgG1/CD54 for medium control [%] |
>105 |
156 |
pass |
160 |
pass |
||||
MFI ratio IgG1/CD54 for DMSO control [%] |
>105 |
162 |
pass |
173 |
pass |
||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.
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.
