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Diss Factsheets

Administrative data

Description of key information

No study on skin sensitisation is available on the registered substance (reaction mass of C12 -C13 acrylate). However the data are available on an analogue substance (reaction mass of C12 -C14 acrylate). Indeed, Laurylacrylate (C12 -C14) is not skin sensitizer based on the three in vitro studies performed.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
In vitro sensitization: Dendritic Cell Line Activation Assay; Myeloid U 937 Skin Sensitization Test (MUSST).
The myeloid U937 skin sensitization test (MUSST) is a dendritic cell activation test to predict skin sensitizing potential. The test is performed using the human pro-monocytic cell line U937 as surrogate for dendritic cells. As readout, the change in the expression of the cell membrane marker CD86 measured by flow cytometry after 48 hours of the test substance exposure was determined.
GLP compliance:
yes
Remarks:
non-GLP, but study conducted under similar Quality assurance system.
Type of study:
activation of dendritic cells
Details on the study design:
The cytotoxicity of the test substance was evaluated by flow cytometry using propidium iodide staining after 48 hours exposure. For the purpose the CV75 value was derived from the concentration response curve. The CV75 is the estimated concentration that affords 75% cell viability and was determined to be 1297.8 µg/mL for Laurylacrylate 1214 under the chosen exposure conditions on U937 cells. In the main test, test substance was assessed at six final concentrations 2595.6 µg/mL, 1297.8 µg/mL, 648.9 µg/mL, 350.0 µg/mL and 324.0 µg/mL to be 162.2 µg/mL for Laurylacrylate 1214 under the chosen exposure conditions on U937 cells.
After 48 hours of exposure U937 cells were stained with FITC labeled anti-human-CD 86 antibody and propidium iodide and the fluorescence intensity was analyzed using flow cytometry. A test substance was predicted to have a dendritic cell activating potential when the marker expression exceeded the threshold of 1.2 with respect to vehicle treated cells (VC) at any tested sufficiently non-cytotoxic (cell viability >/= 70%) concentration in two experiments.
The strong sensitizer ethylene diamine (EDA, 70 µg/mL) was used as positive and lactic acid (LA, 200 µg/mL) as non-sensitizing negative control.
Key result
Run / experiment:
other: treated
Parameter:
other: CD86 expression
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Remarks on result:
no indication of skin sensitisation
Other effects / acceptance of results:
In summary, after 48 hours of exposure to test substance Laurylacrylate 1214 CD 86 expression was not induced in U937 cells at concentration between 162.2 to 2595.6 µg/mL affording at least 70% viability. From this it has to be concluded that test substance Laurylacrylate 1214 does not induce dendritic cell activation.
Interpretation of results:
other: no induction dendritic cell activation.
Conclusions:
In summary, after 48 hours of exposure to test substance Laurylacrylate 1214 CD 86 expression was not induced in U937 cells at concentration between 162.2 to 2595.6 µg/mL affording at least 70% viability. From this it has to be concluded that test substance Laurylacrylate 1214 does not induce dendritic cell activation.
Executive summary:

The myeloid U937 skin sensitization test (MUSST) is a dendritic cell activation test to predict skin sensitizing potential. The test is performed using the human pro-monocytic cell line U937 as surrogate for dendritic cells. As readout, the change in the expression of the cell membrane marker CD86 measured by flow cytometry after 48 hours of the test substance exposure was determined.

The cytotoxicity of the test substance was evaluated by flow cytometry using propidium iodide staining after 48 hours exposure. For the purpose the CV75 value was derived from the concentration response curve. The CV75 is the estimated concentration that affords 75% cell viability and was determined to be 1297.8 µg/mL for Laurylacrylate 1214 under the chosen exposure conditions on U937 cells. In the main test, test substance was assessed at six final concentrations 2595.6 µg/mL, 1297.8 µg/mL, 648.9 µg/mL, 350.0 µg/mL and 324.0 µg/mL to be 162.2 µg/mL for Laurylacrylate 1214 under the chosen exposure conditions on U937 cells.

After 48 hours of exposure U937 cells were stained with FITC labeled anti-human-CD 86 antibody and propidium iodide and the fluorescence intensity was analyzed using flow cytometry. A test substance was predicted to have a dendritic cell activating potential when the marker expression exceeded the threshold of 1.2 with respect to vehicle treated cells (VC) at any tested sufficiently non-cytotoxic (cell viability >/= 70%) concentration in two experiments. The strong sensitizer ethylene diamine (EDA, 70 µg/mL) was used as positive and lactic acid (LA, 200 µg/mL) as non-sensitizing negative control.

In summary, after 48 hours of exposure to test substance Laurylacrylate 1214 CD 86 expression was not induced in U937 cells at concentration between 162.2 to 2595.6 µg/mL affording at least 70% viability. From this it has to be concluded that test substance Laurylacrylate 1214 does not induce dendritic cell activation.

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
In vitro Sensitization: Direct Peptice Reactivity Assay (DPRA)
GLP compliance:
yes
Remarks:
non-GLP, but study conducted under similar Quality assurance system.
Type of study:
direct peptide reactivity assay (DPRA)
Details on the study design:
The test substance was solved at a 100 mM concentration in acetonitrile. Three samples of the test substance were incubated with each peptide in ratios of 1:10 (for C-peptide) or 1:50 (for K-peptide). Additionally triplicates of the concurrent vehicle control (= NC) were incubated with the peptides. The peptide depletion of test-substance incubated samples was compared to the peptide depletion of the NC samples and expressed as relative peptide depletion. For the test substance the mean peptide depletion as average of C- and K-peptide depletion is calculated and used for evaluation of the chemical reactivity.

The study is performed according to the methods described in the following publications:
Bauch C, Kolle SN, Ramirez-Hernandez T, Eltze T, Fabian E, Teubner W, Mehling A, van Ravenzwaay B, Landsiedel R. Putting the parts together: Combining in vitro methods to test for skin sensitizing. Regulatory Toxicology and Pharmacology 63(3), 489-504, 2012. 2 Gerberick GF, Vassallo JD, Foertsch LM, Price BB, Chaney JG, Lepoittevin JP. Quantification of Chemical Peptide Reactivity for Screening Contact Allergens: A Classification Tree Model Approach. Toxicological Sciences 97(2), 417-427, 2007.
Key result
Run / experiment:
other: treated
Parameter:
other: Mean cysteine and lysine peptide depletion (%)
Value:
16.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
94.2%
Positive controls validity:
not applicable
Remarks on result:
other: low reactivity
Run / experiment:
other: treated
Parameter:
other: cysteine -peptide reactivity (%)
Value:
30.1
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
100%
Positive controls validity:
not applicable
Remarks on result:
other: moderate reactivity
Run / experiment:
other: treated
Parameter:
other: lysine-peptide reactivity (%)
Value:
2.8
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
88.4%
Positive controls validity:
not applicable
Remarks on result:
other: minimal reactivity
Interpretation of results:
other: low chemical reactivity
Conclusions:
The test substance was solved in acetonitrile. However, when mixed with the peptide stock solutions the samples became opaque. Visual observation after the 24-hour incubation time revealed precipitates in all samples. Based on the observed results and applying the prediction model proposed in Geberick et. al (2007) it was concluded that Laurylacrylate 1214 shows low chemical reactivity in the DPRA under the conditons chosen.
Endpoint:
skin sensitisation: in vitro
Remarks:
other: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
In vitro Test LuSens (Bauch et al. 2012)
GLP compliance:
yes
Remarks:
non-GLP, but study conducted under similar Quality assurance system.
Type of study:
activation of keratinocytes
Details on the study design:
The cell line LuSens was treated with 6 test substance concentrations for 48 hours in at least two independent experiments with each 3 replicates. Cells were lysed and luciferase induction was evaluated by measuring luminescence signal after substrate addition (Steady Glo®, Promega). ln parallel a MTT assay was performed to assess cytotoxicity of the test substance. A test substance was considered to have an ARE induction potential if the fold induction of luciferase activity was > 1.5 and viability determined in the MTT assay was > 70% at any test concentration.
Key result
Run / experiment:
other: treated
Parameter:
other: luciferase activation (µg/ml)
Value:
6.82
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Other effects / acceptance of results:
ln summary, after 48 hours of exposure to test substance Laurylacrylate 1214 luciferase activity in LuSens cells was induced at concentration between 6.82 and 9.81 µg/mL affording at least 70% viability. From this it has to be concluded that test substance Laurylacrylate 1214 has an keratinocyte activating potential.
Interpretation of results:
other: keratinocyte activating potential
Conclusions:
ln summary, after 48 hours of exposure to test substance Laurylacrylate 1214 luciferase activity in LuSens cells was induced at concentration between 6.82 and 9.81 µg/mL affording at least 70% viability. From this it has to be concluded that test substance Laurylacrylate 1214 has an keratinocyte activating potential.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In the DPRA test, the test substance was solved in acetonitrile. However, when mixed with the peptide stock solutions the samples became opaque. Visual observation after the 24-hour incubation time revealed precipitates in all samples. Based on the observed results and applying the prediction model proposed in Geberick et. al (2007) it was concluded that Laurylacrylate 1214 shows low chemical reactivity in the DPRA under the conditions chosen.

ln the LuSens test, after 48 hours of exposure to test substance Laurylacrylate 1214 luciferase activity in LuSens cells was induced at concentration between 6.82 and 9.81 µg/mL affording at least 70% viability. From this it has to be concluded that test substance Laurylacrylate 1214 has an keratinocyte activating potential.

 

The myeloid U937 skin sensitization test (MUSST) is a dendritic cell activation test to predict skin sensitizing potential. The test is performed using the human pro-monocytic cell line U937 as surrogate for dendritic cells. As readout, the change in the expression of the cell membrane marker CD86 measured by flow cytometry after 48 hours of the test substance exposure was determined.

The cytotoxicity of the test substance was evaluated by flow cytometry using propidium iodide staining after 48 hours exposure. For the purpose the CV75 value was derived from the concentration response curve. The CV75 is the estimated concentration that affords 75% cell viability and was determined to be 1297.8 µg/mL for Laurylacrylate 1214 under the chosen exposure conditions on U937 cells. In the main test, test substance was assessed at six final concentrations 2595.6 µg/mL, 1297.8 µg/mL, 648.9 µg/mL, 350.0 µg/mL and 324.0 µg/mL to be 162.2 µg/mL for Laurylacrylate 1214 under the chosen exposure conditions on U937 cells.

After 48 hours of exposure U937 cells were stained with FITC labeled anti-human-CD 86 antibody and propidium iodide and the fluorescence intensity was analyzed using flow cytometry. A test substance was predicted to have a dendritic cell activating potential when the marker expression exceeded the threshold of 1.2 with respect to vehicle treated cells (VC) at any tested sufficiently non-cytotoxic (cell viability >/= 70%) concentration in two experiments. The strong sensitizer ethylene diamine (EDA, 70 µg/mL) was used as positive and lactic acid (LA, 200 µg/mL) as non-sensitizing negative control.

In summary, after 48 hours of exposure to test substance Laurylacrylate 1214 CD 86 expression was not induced in U937 cells at concentration between 162.2 to 2595.6 µg/mL affording at least 70% viability. From this it has to be concluded that test substance Laurylacrylate 1214 does not induce dendritic cell activation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, no classification for skin sensitisation is required for the reaction mass of C12 -C13 acrylate according to the Regulation EC n°1272/2008.