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EC number: 941-809-7 | CAS number: -
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-03-07 to 2016-04-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- adopted: February 04, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Direct Peptide Reactivity Assay (DPRA) for Skin Sensitization Testing, DB-ALM Protocol n°154
- Version / remarks:
- January 12, 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- The Direct Peptide Reactivity Assay (DPRA) is accepted as a reliable and relevant replacement test for in vivo skin sensitisation testing.
Test material
- Reference substance name:
- (8Z)-16-{[(2R,4S,5S)-6-[(acetyloxy)methyl]-3-{[(2S,4S,5S)-6-[(acetyloxy)methyl]-3,4,5-trihydroxyoxan-2-yl]oxy}-4,5-dihydroxyoxan-2-yl]oxy}heptadec-8-enoic acid; [(1S,4S,5S,8R,17Z,27S,31R)-28-[(acetyloxy)methyl]-4,5,30,31-tetrahydroxy-10-methyl-25-oxo-2,7,9,26,29-pentaoxatricyclo[25.2.2.0³,⁸]hentriacont-17-en-6-yl]methyl acetate
- EC Number:
- 941-809-7
- IUPAC Name:
- (8Z)-16-{[(2R,4S,5S)-6-[(acetyloxy)methyl]-3-{[(2S,4S,5S)-6-[(acetyloxy)methyl]-3,4,5-trihydroxyoxan-2-yl]oxy}-4,5-dihydroxyoxan-2-yl]oxy}heptadec-8-enoic acid; [(1S,4S,5S,8R,17Z,27S,31R)-28-[(acetyloxy)methyl]-4,5,30,31-tetrahydroxy-10-methyl-25-oxo-2,7,9,26,29-pentaoxatricyclo[25.2.2.0³,⁸]hentriacont-17-en-6-yl]methyl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Preparation of the Test Item
The test item was freshly prepared immediately prior to use, unless stability data demonstrate the acceptability of storage. The test item was pre-weighted into a glass vial and was dissolved in an appropriate solvent previously determined in a pre-experiment. A stock solution with a concentration of 100 mM was prepared.
In chemico test system
- Details on the study design:
- The DPRA is supposed to address the molecular initiating event of the adverse outcome pathway (AOP), namely protein reactivity, by quantifying the reactivity of test chemicals towards synthetic model peptides containing either lysine or cysteine. The percentage depletion value of the cysteine and lysine peptide is used to categorize a substance in one of four reactivity classes to support discrimination between skin sensitisers and non-sensitisers.
The correlation of protein reactivity with skin sensitisation potential of a chemical is well established and represents the first and initial key event in the skin sensitisation process as defined by the AOP. It is therefore a crucial step for the sensitising potential of a chemical.
This test may be used for the hazard identification of sensitising chemicals in accordance with UN GHS “Category 1”. It does not allow the classification of chemicals to the subcategories 1A and 1B as defined by UN GHS nor predict potency for safety assessment decisions. Therefore, all substances giving a positive result in the DPRA will be classified into UN GHS “Category 1”.
For detailed information on experimental procedure, materials, methods, controls, prediction model and acceptance criteria please see section “any other details on materials and methods incl. tables”.
Results and discussion
- 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 62.90 %.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Both Cysteine and Lysine
- Parameter:
- other: mean peptide depletion [%]
- Value:
- 2.03
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Run / experiment:
- other: Cysteine
- Parameter:
- other: mean peptide depletion [%]
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Values were set to zero due to negative depletion
- Run / experiment:
- other: Lysine
- Parameter:
- other: mean peptide depletion [%]
- Value:
- 4.07
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: not reported
ACCEPTANCE OF RESULTS: all criteria were fulfilled. For details, please see Tables 10 and 11 in section “any other details on results incl. tables”.
Any other information on results incl. tables
Pre-Experiments
Solubility of the test item was determined prior to the main experiment. All test item solutions were freshly prepared immediately prior to use. The test item was not soluble in acetonitrile but completely soluble in water. No turbidity, precipitation and phase separation were observed for the test item solutions. All test item preparations of the main experiment were prepared using water.
Precipitation and Phase Separation
All test item solutions were freshly prepared immediately prior to use.
For the 100 mM stock solution of the test item no turbidity or precipitation was observed when diluted with the cysteine peptide solution.
For the 100 mM stock solution of the test item no turbidity or 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 of the cysteine peptide run were inspected for precipitation, turbidity or phase separation. Precipitation was observed for the test item samples, positive control, RC A, RC B, RC C and for STD 1 and 2. Samples were not centrifuged prior to the HPLC analysis.
After the 24 h ± 2 h incubation period but prior to the HPLC analysis samples of the lysine peptide run were inspected for precipitation, turbidity or phase separation. No precipitation, turbidity or phase separation was observed for the any test item samples. Slight phase separation was observed for the positive control and the respective co-elution control.
After the HPLC run samples of the cysteine peptide run were inspected for precipitation, turbidity or phase separation. Precipitation was observed for the test item samples, positive control, RC A, RC B, RC C and for STD 1, 2 and 3.
After the HPLC run samples of the lysine peptide run were inspected for precipitation, turbidity or phase separation. No precipitation, turbidity or phase separation was observed for the any test item samples. Slight phase separation was observed for the positive control and the respective co-elution control.
Co-elution with the peptide peak
No co-elution of the test item with any of the peptide peaks was observed.
Results Calibration Curve
Table 6: Cysteine and Lysine Values of the Calibration Curve
Sample |
Cysteine Peptide |
Lysine Peptide |
||
Peak Area |
Peptide Concentration [mM] |
Peak Area |
Peptide Concentration [mM] |
|
STD1 |
3495.8242 |
0.5340 |
3675.5410 |
0.5340 |
STD2 |
1805.4337 |
0.2670 |
1867.7395 |
0.2670 |
STD3 |
944.5201 |
0.1335 |
985.2802 |
0.1335 |
STD4 |
466.7887 |
0.0667 |
516.4465 |
0.0667 |
STD5 |
237.0339 |
0.0334 |
282.1445 |
0.0334 |
STD6 |
116.4341 |
0.0167 |
179.8809 |
0.0167 |
STD7 |
0.0000 |
0.0000 |
0.0000 |
0.0000 |
Based on these results, linear regression was performed and the following calibration curves were determined:
Cysteine Peptide Calibration Curve : y = 6546.17x + 26.29 ; R2= 0.9995
Lysine Peptide Calibration Curve : y = 6805.79x + 50.30 ; R2= 0.9996
Results of the Cysteine Peptide Depletion
Table 7: Depletion of the Cysteine Peptide. * Values were set to zero due to negative depletion.
Cysteine Peptide |
||||||
Sample |
Peak Area |
Peptide Conc. [mM] |
Peptide Depletion [%] |
Mean Peptide Depletion [%] |
SD of Peptide Depletion [%] |
CV of Peptide Depletion [%] |
Positive Control |
906.7542 |
0.1345 |
71.54 |
72.27 |
0.90 |
0.01 |
892.3105 |
0.1323 |
71.99 |
||||
851.7282 |
0.1261 |
73.27 |
||||
Test Item |
3217.3611 |
0.4875 |
0.00* |
0.00 |
0.00 |
- |
3224.2549 |
0.4885 |
0.00* |
||||
3206.4368 |
0.4858 |
0.00* |
Results of the Lysine Peptide Depletion
Table 8: 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 |
1608.7321 |
0.2290 |
53.57 |
53.53 |
0.22 |
0.00 |
1618.3588 |
0.2304 |
53.29 |
||||
1603.4867 |
0.2282 |
53.72 |
||||
Test Item |
3266.0764 |
0.4725 |
4.10 |
4.07 |
0.10 |
0.02 |
3271.2881 |
0.4733 |
3.95 |
||||
3264.7769 |
0.4723 |
4.14 |
Detailed results about the reference controls can be found in Table 15.
Categorization of the Test Item
Based on the results of the peptide depletion, categorization according to the prediction model was performed. In case that no co-elution was detected, the prediction model based on the combination of cysteine and lysine peptide should be used. Since no co-elution was observed the prediction model of cysteine and lysine was used.
Table 9: Categorization of the Test Item
Predicition Model |
Prediction Model 1 |
Prediction Model 2 |
||||
Test Substance |
Mean Peptide Depletion [%] |
Reactivity Category |
Prediction |
Mean Peptide Depletion [%] |
Reactivity Category |
Prediction |
Test Item |
2.03 |
Minimal reactivity |
No sensitiser |
0.00 |
Minimal reactivity |
No sensitiser |
Positive Control |
62.90 |
High reactivity |
sensitizer |
72.27 |
Moderate reactivity |
sensitizer |
Acceptance Criteria
Table 10: Acceptance Criteria for Cysteine Peptide
Cysteine Peptide Run |
|||
Acceptance Criterion |
Range |
Value |
pass/fail |
coefficient of determination |
R2> 0.99 |
0.9995 |
pass |
mean peptide concentration of RC A |
0.45 ≤ x ≤ 0.55 mM |
0.4969 |
pass |
mean peptide concentration of RC C (PC) |
0.45 ≤ x ≤ 0.55 mM |
0.4827 |
pass |
mean peptide concentration of RC C (TI) |
0.45 ≤ x ≤ 0.55 mM |
0.4584 |
pass |
CV of the peak area of RC B |
< 15 % |
2.38 |
pass |
CV of the peak area of RC C (PC) |
< 15 % |
0.85 |
pass |
CV of the peak area of RC C (TI) |
< 15 % |
9.07 |
pass |
mean peptide depletion of the PC |
60.8 % < x < 100 % |
72.27 |
pass |
SD of peptide depletion of the PC replicates |
< 14.9 % |
0.90 |
pass |
SD of peptide depletion of the TI replicates |
< 14.9 % |
0.00 |
pass |
Table 11: Acceptance Criteria for Lysine Peptide
Lysine Peptide Run |
|||
Acceptance Criterion |
Range |
Value |
pass/fail |
coefficient of determination |
R² > 0.99 |
0.9996 |
pass |
mean peptide concentration of RC A |
0.45 ≤ x ≤ 0.55 mM |
0.5067 |
pass |
mean peptide concentration of RC C (PC) |
0.45 ≤ x ≤ 0.55 mM |
0.5017 |
pass |
mean peptide concentration of RC C (TI) |
0.45 ≤ x ≤ 0.55 mM |
0.4930 |
pass |
CV of the peak area of RC B |
< 15 % |
0.54 |
pass |
CV of the peak area of RC C (PC) |
< 15 % |
0.61 |
pass |
CV of the peak area of RC C (TI) |
< 15 % |
0.54 |
pass |
mean peptide depletion of the PC |
40.2 % < x < 69.0 % |
53.53 |
pass |
SD of peptide depletion of the PC replicates |
< 11.6 % |
0.22 |
pass |
SD of peptide depletion of the TI replicates |
< 11.6 % |
0.00 |
pass |
Table 12: Historical Data Cysteine Peptide
Cysteine Peptide |
|||
|
mean |
SD |
N |
linearity of the calibration curve |
0.9991 |
0.0006 |
8 |
mean peptide concentration of reference A [mM] |
0.52 |
0.00 |
8 |
mean peptide concentration of reference C [mM] |
0.50 |
0.00 |
10 |
CV of the peak area of control B [%] |
2.10 |
0.34 |
8 |
CV of the peak area of control C [%] |
1.60 |
0.85 |
10 |
mean peptide depletion of the PC [%] |
74.67 |
2.32 |
8 |
SD of peptide depletion of the PC replicates [%] |
0.84 |
0.72 |
8 |
SD of peptide depletion of the test items [%] |
4.60 |
14.80 |
20 |
Table 13: Historical Data Lysine Peptide
Lysine Peptide |
|||
|
mean |
SD |
N |
linearity of the calibration curve |
0.9998 |
0.0001 |
7 |
mean peptide concentration of reference A [mM] |
0.49 |
0.02 |
7 |
mean peptide concentration of reference C [mM] |
0.49 |
0.24 |
9 |
CV of the peak area of control B [%] |
1.26 |
0.24 |
7 |
CV of the peak area of control C [%] |
0.81 |
0.89 |
9 |
mean peptide depletion of the PC [%] |
59.54 |
6.09 |
7 |
SD of peptide depletion of the PC replicates [%] |
2.58 |
1.90 |
7 |
SD of peptide depletion of the test items [%] |
1.02 |
1.08 |
21 |
Table 14: Exemplary Analysis Sequence
Run 1 Run 2 Run 3 Run 4 Run 5 Run 6 Run 7 Run 8 Run 9 Run 10 Run 11 |
STD1 STD2 STD3 STD4 STD5 STD6 SDT7 (DB) Reference Control A, replicate 1 Reference Control A, replicate 2 Reference Control A, replicate 3 |
Run 12 Run 13 |
Co-Elution Control Positive Control Co-Elution Test Item 1 |
Run 14 Run 15 Run 16 |
Reference Control B, replicate 1 Reference Control B, replicate 2 Reference Control B, replicate 3 |
Run 17 Run 18 Run 19 |
Reference Control C, replicate 1 Positive Control, replicate 1 Test Item 1, replicate 1 |
Run 20 Run 21 Run 22 |
Reference Control C, replicate 2 Positive Control, replicate 2 Test Item 1, replicate 2 |
Run 23 Run 24 Run 25 |
Reference Control C, replicate 3 Positive Control, replicate 3 Test Item 1, replicate 3 |
Run 26 Run 27 Run 28 |
Reference Control B, replicate 4 Reference Control B, replicate 5 Reference Control B, replicate 6 |
Table 15: Results of the Reference Controls for the Cysteine Peptide
Cysteine Peptide Run |
|||||||||
Sample |
Peptide Peak Area |
Peptide Concentration [mM] |
|||||||
PA |
Mean |
SD |
CV [%] |
Peptide Concentration |
Mean |
SD |
CV [%] |
||
Reference A 1 |
3295.67 |
3278.9512 |
26.0108 |
0.79 |
0.4994 |
0.4969 |
0.0040 |
0.80 |
|
Reference A 2 |
3292.20 |
0.4989 |
|||||||
Reference A 3 |
3248.98 |
0.4923 |
|||||||
Reference B 1 |
3211.87 |
3162.2388 |
74.5299 |
2.36 |
0.4866 |
0.4791 |
0.0114 |
2.38 |
|
Reference B 2 |
3253.24 |
0.4930 |
|||||||
Reference B 3 |
3222.13 |
0.4882 |
|||||||
Reference B 4 |
3097.92 |
0.4692 |
|||||||
Reference B 5 |
3090.32 |
0.4681 |
|||||||
Reference B 6 |
3097.95 |
0.4692 |
|||||||
Reference C 1 (PC solvent) |
3208.51 |
3186.06 |
26.9566 |
0.85 |
0.4861 |
0.4827 |
0.0041 |
0.85 |
|
Reference C 2 (PC solvent) |
3193.52 |
0.4838 |
|||||||
Reference C 3 (PC solvent) |
3156.16 |
0.4781 |
|||||||
Reference C 1 (TI solvent) |
3205.63 |
3027.02 |
272.2805 |
8.99 |
0.4857 |
0.4584 |
0.0416 |
9.07 |
|
Reference C 2 (TI solvent) |
2713.64 |
0.4105 |
|||||||
Reference C 3 (TI solvent) |
3161.80 |
0.4790 |
Table 16: Results of the Reference Controls for the Lysine Peptide
Lysine Peptide Run |
|||||||||
Sample |
Peptide Peak Area |
Peptide Concentration [mM] |
|||||||
PA |
Mean |
SD |
CV [%] |
Peptide Concentration |
Mean |
SD |
CV [%] |
||
Reference A 1 |
3484.17 |
3498.5079 |
12.6544 |
0.36 |
0.5046 |
0.5067 |
0.0019 |
0.37 |
|
Reference A 2 |
3508.10 |
0.5081 |
|||||||
Reference A 3 |
3503.26 |
0.5074 |
|||||||
Reference B 1 |
3472.14 |
3482.0649 |
18.3933 |
0.53 |
0.5028 |
0.5042 |
0.0027 |
0.54 |
|
Reference B 2 |
3506.05 |
0.5078 |
|||||||
Reference B 3 |
3497.27 |
0.5065 |
|||||||
Reference B 4 |
3473.01 |
0.5029 |
|||||||
Reference B 5 |
3487.77 |
0.5051 |
|||||||
Reference B 6 |
3456.15 |
0.5004 |
|||||||
Reference C 1 (PC solvent) |
3445.89 |
3465.01 |
20.6789 |
0.60 |
0.4989 |
0.5017 |
0.0030 |
0.61 |
|
Reference C 2 (PC solvent) |
3462.18 |
0.5013 |
|||||||
Reference C 3 (PC solvent) |
3486.96 |
0.5050 |
|||||||
Reference C 1 (TI solvent) |
3426.42 |
3405.85 |
18.0704 |
0.53 |
0.4961 |
0.4930 |
0.0027 |
0.54 |
|
Reference C 2 (TI solvent) |
3392.54 |
0.4911 |
|||||||
Reference C 3 (TI solvent) |
3398.60 |
0.4920 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Expert judgement: no indication of sensitisation
- Conclusions:
- In this study under the given conditions the test item showed minimal reactivity towards the peptides. The test item can be considered as “non-sensitizer”. The data generated with this method may be not sufficient to conclude on the absence of skin sensitisation potential of chemicals and will be considered in the context of integrated approach.
- Executive summary:
The in chemico direct peptide reactivity assay (DPRA) enables detection of the sensitising potential
of a test item by addressing the molecular initiating event of the adverse outcome pathway (AOP),
namely protein reactivity, by quantifying the reactivity of test chemicals towards synthetic peptides
containing either lysine or cysteine. The percentage depletion value of the cysteine and lysine
peptide is used to categorize a substance in one of four reactivity classes to support discrimination
between skin sensitiser and non-sensitisers.
In the present study, the test item was dissolved in water and 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 analysis.
After the 24 h ± 2 h incubation period but prior to the HPLC analysis samples of the cysteine and lysine peptide run were inspected for precipitation, turbidity or phase separation. Precipitation was observed for the test item samples, RC A, RC B, RC C, positive control and for STD 1 and 2 of the cysteine run. No centrifugation was necessary to perform the HPLC analysis. Slight phase separation was observed for the positive control and the respective co-elution control of the lysine run.
After the HPLC run samples of the cysteine peptide run were inspected for precipitation, turbidity or phase separation. Precipitation was observed for the test item samples, RC A, RC B, RC C, positive control and for STD 1, 2 and 3 of the cysteine runs. Slight phase separation was observed for the positive control and the respective co-elution control of the lysine run.
Since the turbidity noted for the test item samples was also observed for reference controls, positive controls and standard solutions it can be considered that it is related to the peptide and that it is not a precipitation of the test substance. Additionally, the turbidity did not change during the HPLC analysis period. Since stability of the cysteine peptide in the used acetonitrile batch was demonstrated successfully, the reactivity of the positive control towards the cysteine peptide and peptide depletion were identified correctly and the validity of the cysteine run was acceptable the precipitation was considered as not relevant.
No co-elution of test item with the peptide peaks was observed. Sensitizing potential of the test item was predicted from the mean peptide depletion of both analysed peptides (cysteine and lysine) by comparing the peptide concentration of the test item treated samples to the corresponding reference control C (RC C).
The 100 mM stock solution of the test item showed minimal reactivity towards the synthetic peptides. The mean depletion of both peptides was ≤6.38 % (2.03 %). Based on the prediction model 1 the test item can be considered as non-sensitiser.
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 62.90 %.
The controls confirmed the validity of the study for both, the cysteine and lysine run. For the cysteine run the coefficient of determination for the calibration curve was >0.99 (0.9995). The mean peptide depletion of the cysteine peptide by the positive control was between 60.8 % and 100 % (72.27 %).
The mean peptide concentration of reference control A and reference control C (acetonitrile and water) was between >0.45 and <0.55 mM (RC A: 0.4969 mM, RC C (acetonitrile): 0.4827 mM, RC C (water): 0.4584 mM). The coefficient of variation (CV) of the peak area (PA) of reference control B and reference control C (acetonitrile and water) was <15 %. (RC B: 2.38 %, RC C (acetonitrile): 0.85 %, RC C (water): 9.07 %). The SD of the peptide depletion for the replicates of the positive control as well as for the tested test item samples was <14.9 % (PC: 0.90 %; test item 0.00 %).
For the lysine run the coefficient of determination for the calibration curve was >0.99 (0.9996). The mean peptide depletion of the lysine peptide by the positive control was between 40.2 % and 69.0 % (53.53 %). The mean peptide concentration of reference control A and reference control C (acetonitrile and water) was between >0.45 and < 0.55 mM (RC A 0.5067 mM, RC C (acetonitrile): 0.5017 mM, RC C water): 0.4930 mM). The coefficient of variation (CV) of the peak area (PA) of reference control B and reference control C (acetonitrile and water) was <15 %. (RC B: 0.54 %, RC C (acetonitrile: 0.61 %, RC C water): 0.54 %). The SD of the peptide depletion for the replicates of the positive control as well as for the tested test item samples was <11.6 % (PC: 0.22 %; test item: 0.10 %).
The test item can be considered as non-sensitiser. The data generated with this test will be considered in the context of an integrated approached such as IATA, combining this result with other complementary information.
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