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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation was studied in vitro using the three key events, namely the DPRA, the Keratinosens and the hClat Assay.


 


In the DPRA assay the 100 mM stock solution of the test item showed minimal reactivity towards the synthetic peptide. The mean depletion of the cysteine peptide was ≤ 13.89 % (2.94 %). Based on the prediction model 2 the test item can be considered as non-sensitiser.


 


In the KeratinoSens assay 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 as sensitiser.


 


The third key event, the hClat assay, was started to verify this result. 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 can be considered as nonsensitiser.


 


Overall, two of the three key events resulted in negative results, indicating that no classification for skin sensitisation according to CLP regulation (EC) No 1272/2008 is justified.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in chemico
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2018-03-27 to 2018-04-07
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 68.26%.
Key result
Run / experiment:
other: cysteine run
Parameter:
other: mean peptide depletion [%]
Value:
2.94
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:
0.03
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.

Cysteine and Lysine Values of the Calibration Curve


































































Sample



Cysteine Peptide



Lysine Peptide



Peak Area
at 220 nm



Peptide Concentration [mM]



Peak Area
at 220 nm



Peptide Concentration [mM]



STD1



5138.8990



0.5340



4282.5977



0.5340



STD2



2651.5103



0.2670



2162.7876



0.2670



STD3



1325.9341



0.1335



1090.6255



0.1335



STD4



655.7342



0.0667



532.2374



0.0667



STD5



319.7461



0.0334



267.5374



0.0334



STD6



151.5604



0.0167



134.4307



0.0167



STD7



0.0000



0.0000



0.0000



0.0000



 


Depletion of the Cysteine Peptide
























































Cysteine Peptide



Sample



Peak Area
at 220 nm



Peptide Conc. [mM]



Peptide Depletion [%]



Mean Peptide Depletion [%]



SD of Peptide Depletion [%]



CV of Peptide Depletion [%]



Positive Control



1463.3074



0.1502



70.30



70.42



0.10



0.15



1455.7604



0.1494



70.46



1453.6044



0.1492



70.50



Test Item



4720.6089



0.4872



4.20



2.94



1.09



37.12



4813.5303



0.4968



2.32



4814.0908



0.4969



2.31



 


Depletion of the Lysine Peptide
























































Lysine Peptide



Sample



Peak Area
at 220 nm



Peptide Conc. [mM]



Peptide Depletion [%]



Mean Peptide Depletion [%]



SD of Peptide Depletion [%]



CV of Peptide Depletion [%]



Positive Control



1317.4542



0.1636



67.49



66.09



1.31



1.98



1382.0761



0.1716



65.90



1422.7880



0.1767



64.89



Test Item



4069.6235



0.5063



0.00



0.03



0.05



173.21



4048.8650



0.5037



0.09



4064.5757



0.5056



0.00



 


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
(Cysteine Peptide and Lysine Peptide / Ratio: 1:10 and 1:50)



Prediction Model 2
(Cysteine Peptide / Test Item Ratio: 1:10)



Test Substance



Mean Peptide Depletion [%]



Reactivity Category



Prediction



Mean Peptide Depletion [%]



Reactivity Category



Prediction



Test Item



--



--



--



2.94



Minimal Reactivity



no sensitiser



Positive Control



68.26



High Reactivity



sensitiser



70.42



Moderate Reactivity



sensitiser



 

Interpretation of results:
GHS criteria not met
Conclusions:
In this study under the given conditions the test item showed minimal reactivity towards the cysteine peptide. The test item is 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.
Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2018-02-07 to 2018-07-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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.

Vehicle / solvent control:
DMSO
Negative control:
other: DMSO
Positive control:
cinnamic aldehyde [442D]
Positive control results:
The luciferase activity induced by the positive control at a concentration of 64 µM was between 2 and 8 (3.42 (experiment 1); 2.84 (experiment 2)).
Key result
Run / experiment:
run/experiment 1
Parameter:
other: luciferase activity fold induction
Value:
2.1
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: At concentration: 0.25 mM
Key result
Run / experiment:
run/experiment 1
Parameter:
other: cell viability [%]
Value:
55.5 %
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: At concentration 0.25 mM
Key result
Run / experiment:
run/experiment 1
Parameter:
EC 1.5 [442D]
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
not determinable
Key result
Run / experiment:
run/experiment 2
Parameter:
other: luciferase activity fold induction
Value:
2
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: At concentration 0.25 mM
Key result
Run / experiment:
run/experiment 2
Parameter:
other: cell viability [%]
Value:
71 %
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: At concentration 0.25 mM
Key result
Run / experiment:
run/experiment 2
Parameter:
EC 1.5 [442D]
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
not determinable
Key result
Run / experiment:
run/experiment 3
Parameter:
other: luciferase activity fold induction
Value:
1.54
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: At concentration 0.022 mM
Key result
Run / experiment:
run/experiment 3
Parameter:
other: cell viability
Value:
102.6 %
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
run/experiment 3
Parameter:
EC 1.5 [442D]
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.

Results of the Cytotoxicity Measurement

























































































































































































 



Conc. [µM]



Cell Viability [%]



Experiment 3



Experiment 1



Experiment 2



Mean



SD



Conc. [µM]



Cell Viability [%]



Solvent Control



-



100



100



100



0.0



-



100



Positive Control



4.00



117.0



104.3



110.7



9.0



4.00



104.4



8.00



102.3



95.9



99.1



4.5



8.00



102.2



16.00



96.9



100.2



98.5



2.3



16.00



106.9



32.00



88.1



101.5



94.8



9.5



32.00



101.1



64.00



69.2



98.5



83.8



20.7



64.00



104.3



Test Item



0.98



91.5



93.8



92.7



1.6



21.18



102.6



1.95



126.0



109.4



117.7



11.7



28.23



101.5



3.91



119.6



103.9



111.8



11.1



37.63



101.6



7.81



108.6



100.3



104.4



5.8



50.16



94.7



15.63



102.4



101.0



101.7



1.0



66.86



95.3



31.25



90.7



84.1



87.4



4.6



89.12



90.2



62.50



84.7



87.6



86.2



2.0



118.80



85.7



125.00



74.8



76.5



75.7



1.2



158.36



82.7



250.00



55.5



71.0



63.3



11.0



211.10



69.1



500.00



1.2



65.1



33.1



45.2



281.39



68.0



1000.00



0.9



0.1



0.5



0.5



375.09



67.0



2000.00



0.2



0.3



0.2



0.1



500.00



48.8



 


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



1.02



1.04



1.29



1.12



0.15



 



8.00



1.14



1.02



1.22



1.13



0.10



 



16.00



1.26



1.33



1.29



1.29



0.04



 



32.00



1.85



1.69



1.77



1.77



0.08



*



64.00



3.11



3.61



3.55



3.42



0.27



*



Test Item



0.98



1.08



1.10



1.13



1.10



0.02



 



1.95



1.02



0.93



1.03



0.99



0.05



 



3.91



0.88



1.08



1.14



1.03



0.14



 



7.81



1.25



0.94



1.23



1.14



0.18



 



15.63



1.06



0.80



1.38



1.08



0.29



 



31.25



1.19



0.90



1.53



1.20



0.32



 



62.50



1.36



1.24



1.58



1.39



0.17



 



125.00



1.68



1.40



2.64



1.90



0.65



 



250.00



2.23



1.74



2.34



2.10



0.32



*



500.00



1.02



0.21



2.35



1.19



1.08



 



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 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



1.11



1.04



1.08



1.08



0.03



 



8.00



1.32



1.18



1.02



1.17



0.15



 



16.00



1.56



1.46



1.30



1.44



0.13



 



32.00



1.79



1.58



1.29



1.55



0.25



*



64.00



2.39



2.24



2.14



2.26



0.13



*



Test Item



0.98



1.08



1.01



1.22



1.10



0.11



 



1.95



0.86



0.90



1.05



0.94



0.10



 



3.91



0.78



0.92



0.87



0.86



0.07



 



7.81



0.84



0.95



0.92



0.90



0.06



 



15.63



1.20



1.21



0.97



1.13



0.14



 



31.25



1.33



1.73



1.37



1.47



0.22



 



62.50



1.30



1.44



1.19



1.31



0.13



 



125.00



1.52



1.59



1.52



1.54



0.04



*



250.00



1.96



2.17



1.87



2.00



0.15



*



500.00



2.05



1.99



1.55



1.86



0.27



*



1000.00



-0.01



0.00



0.00



0.00



0.00



 



2000.00



-0.01



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



Solvent Control



-



1.00



1.00



1.00



1.00



0.00



 



Positive Control



4.00



1.24



1.20



1.12



1.19



0.06



 



8.00



1.09



1.21



1.11



1.13



0.06



 



16.00



1.98



1.50



1.78



1.75



0.24



*



32.00



2.36



2.86



2.55



2.59



0.25



*



64.00



4.72



5.11



5.00



4.94



0.20



*



Test Item



21.18



1.51



1.58



1.53



1.54



0.04



*



28.23



1.63



1.49



2.17



1.76



0.36



*



37.63



1.37



1.70



1.66



1.58



0.18



*



50.16



1.54



1.74



1.72



1.67



0.11



*



66.86



2.61



2.48



2.40



2.50



0.11



*



89.12



2.52



3.00



2.60



2.71



0.25



*



118.80



3.15



3.29



3.24



3.23



0.07



*



158.36



3.28



3.52



3.39



3.40



0.12



*



211.10



4.13



4.23



4.79



4.38



0.36



*



281.39



5.37



5.80



5.90



5.69



0.28



*



375.09



5.94



6.59



7.29



6.61



0.68



*



500.00



19.48



22.63



23.23



21.78



2.02



*



* = significant induction according to Student’s t-test, p < 0.05         


 


 


 


 


 

Interpretation of results:
GHS criteria not met
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 as sensitiser.

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.

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2018-07-02 to 2018-09-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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.
Vehicle / solvent control:
DMSO
Negative control:
other: DMSO
Positive control:
dinitrochlorobenzene (DNCB) [442E]
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 (371 % experiment 1; 312 % experiment 2) and
200 % for CD54 (237 % experiment 1; 412 % experiment 2) were clearly exceeded.
Key result
Run / experiment:
run/experiment 1
Parameter:
other: relative fluorescence intensity CD86 [%]
Value:
139 %
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: At concentration 0.146 mM
Key result
Run / experiment:
run/experiment 1
Parameter:
other: relative fluorescence intensity CD54 [%]
Value:
71 %
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: At concentration 0.071 mM
Key result
Run / experiment:
run/experiment 2
Parameter:
other: relative fluorescence intensity CD86 [%]
Value:
98 %
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: At concentration 0.146 mM
Key result
Run / experiment:
run/experiment 2
Parameter:
other: relative fluorescence intensity CD54 [%]
Value:
83 %
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: At concentration 0.059 mM
Outcome of the prediction model:
negative [in vitro/in chemico]
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.

Results of the Dose Finding Assay

Sample

Experiment 1

Experiment 2

Concentration applied [µg/mL]

Cell Viability [%]

Concentration applied [µg/mL]

Cell Viability [%]

Medium Control

--

--

95.90

--

96.50

Solvent Control

DMSO

--

95.80

--

96.30

Test material

C8

7.81

95.80

7.81

95.30

C7

15.63

94.70

15.63

94.60

C6

31.25

94.40

31.25

93.30

C5

62.50

92.80

62.50

92.40

C4

125.00

82.30

125.00

87.90

C3

250.00

39.40

250.00

42.60

C2

500.00

15.30

500.00

7.20

C1

1000.00

13.50

1000.00

6.50

Calculated CV75 [µg/mL]

140.65

152.28

Mean CV75 [µg/mL]

146.46

SD CV 75 [µg/mL]

8.22

CD54 and CD86 Expression Experiment 1

Sample

Conc.
[μg/mL]

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

-

96.2

95.2

95.1

2101

939

511

1590

428

119

86

411

184

Solvent Control

0.20%

96.8

95.8

95.3

1840

1003

507

1333

496

100

100

363

198

DNCB

4.00

85.6

84.6

84.9

5532

1761

584

4948

1177

371

237

947

302

Test Material

175.76

17.7

18.9

18.7

1532

888

676

856

212

64

43

227

131

146.47

54.3

53.0

53.2

2499

895

645

1854

250

139

50

387

139

122.06

70.1

68.6

69.8

2183

913

611

1572

302

118

61

357

149

101.71

79.7

80.3

79.9

1972

895

592

1380

303

104

61

333

151

84.76

86.7

86.9

86.0

1782

878

594

1188

284

89

57

300

148

70.63

90.2

89.0

88.9

1872

915

564

1308

351

98

71

332

162

58.86

90.8

90.7

90.2

1767

886

561

1206

325

90

66

315

158

49.05

92.1

91.1

91.2

1792

907

554

1238

353

93

71

323

164

CD54 and CD86 Expression Experiment 2

Sample

Conc.
[μg/mL]

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

-

96.4

96.4

95.5

1915

1062

541

1374

521

78

103

354

196

Solvent Control

0.20%

95.1

94.7

94.5

2297

1033

528

1769

505

100

100

435

196

DNCB

4.0

85.5

85.2

84.1

6126

2685

602

5524

2083

312

412

1018

446

Test material

175.76

42.1

41.7

41.3

2311

960

618

1693

342

96

68

374

155

146.47

66.5

68.7

68.8

2336

999

605

1731

394

98

78

386

165

122.06

76.8

76.8

76.9

2260

996

586

1674

410

95

81

386

170

101.71

85.2

85.6

85.6

1900

926

558

1342

368

76

73

341

166

84.76

87.6

86.8

87.5

2038

923

550

1488

373

84

74

371

168

70.63

89.5

89.6

89.1

1812

911

549

1263

362

71

72

330

166

58.86

92.4

92.4

92.5

1822

954

536

1286

418

73

83

340

178

49.05

91.7

92.9

92.0

1869

911

555

1314

356

74

71

337

164
Interpretation of results:
GHS criteria not met
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 might 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.
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 to classified according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.