Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 911-296-4 | 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
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
- 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.
Referenceopen allclose all
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.
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.