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EC number: 810-760-2 | CAS number: 149855-64-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-propylheptyl methacrylate
- EC Number:
- 810-760-2
- Cas Number:
- 149855-64-1
- Molecular formula:
- C14 H26 O2
- IUPAC Name:
- 2-propylheptyl methacrylate
- Reference substance name:
- 2-Propylheptyl methacrylate
- IUPAC Name:
- 2-Propylheptyl methacrylate
- Details on test material:
- - Name of test material (as cited in study report): 2-Propylheptyl methacrylate
- Physical state:liquid, colorless, clear
- Analytical purity: 99.4 g/100g
- Lot/batch No.: S731900107
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Horst/ The Netherlands
- Age at study initiation: main test: 9 - 10 weeks (pretest: 8 - 9 weeks / 10 - 11 weeks)
- Housing: group (Makrolon Type III, with wire mesh top)
- Diet (e.g. ad libitum): ad libitum (2018C Teklad Global 18% protein rodent diet (certified))
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 35-65 %
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Concentration:
- 5, 10, 25 %
- No. of animals per dose:
- 5
- Details on study design:
- Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 5, 10 and 25% in acetone:olive oil (4+1, v/v). The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (∅ ∼ 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone (control animals).
Five days after the first topical application (day 6) 250 μL of phosphate-buffered saline containing 19.7 μCi of 3H-methyl thymidine (equivalent to 78.9 μCi/mL 3HTdR) were injected into each test and control mouse via the tail vein.
Approximately five hours after treatment with 3HTdR all mice were euthanised by using CO2, which was, after harvesting of the lymph nodes, followed by cervical dislocation to ensure death.
After excision, the lymph nodes were pooled per animal and weighed immediately using an analytical balance. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables, for the ear weights, the lymph node weights and lymph node cell count, and for the DPM values (group mean DPM ± standard deviation). The Dean-Dixon-Test and the Grubb’s test were used for detection of possible outliers (performed with Microsoft Excel 2007).
Results and discussion
- Positive control results:
- The sensitivity and reliability of the experimental technique employed was assessed by use of α-hexyl cinnamaldehyde dissolved in acetone/olive oil (4+1, v/v) (compound listed in OECD 429 Guideline) which is known to have skin sensitisation properties in mice. The periodic positive control experiment was performed using CBA/CaOlaHsd mice in October 2013
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: test substance: 1.17 (5% 2-PHMA); 1.24 (10% 2-PHMA); 1.34 (25% 2-PHMA)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: test substance: 1485.2 (5% 2-PHMA); 1579.4 (10% 2-PHMA); 1703.8 (25% 2-PHMA); vehicle control: 1271.5
Any other information on results incl. tables
Lymph Node Weights and Cell Counts
The measured lymph node weights and –cell counts of all animals treated were recorded after sacrifice. A statistically significant or biologically relevant increase in lymph node weights or –cell counts was not observed in any of the test item treated groups in comparison to the vehicle control group. For BALB/c mice, a cut-off value for the lymph node cell count index of 1.55 was reported for a positive response (See Ref. 8). The indices determined for the lymph node cell count did not exceed this threshold.
Ear Weights
The measured ear weight of all animals treated was recorded on test day 6 (after necropsy). A statistically significant increase in ear weights was observed in the high dose group in comparison to the vehicle control group (p<0.05). Furthermore, the cut-off value (1.1) of the ear weight index for a positive response regarding ear skin irritation reported for BALB/c mice (see Ref. 9) was slightly exceeded in the high dose group (index of 1.12).
Test item concentration |
Group Calculation |
||
Mean DPM per animal (2 lymph nodes)a) |
SD |
S.I. |
|
Vehicle Control Group (acetone:olive oil (4+1, v/v)) |
1271.5 |
518.5 |
1.00 |
5% 2-Propylheptyl methacrylate |
1485.2 |
509.2 |
1.17 |
10% 2-Propylheptyl methacrylate |
1579.4 |
537.8 |
1.24 |
25% 2-Propylheptyl methacrylate |
1703.8 |
692.7 |
1.34 |
a) Mean DPM/animal was determined by dividing the sum of the measured values from lymph nodes of all animals within a group by the number of animals in that group (5 animals; except for the vehicle control group with 4 animals, as animal 3 was identified as an outlier and excluded from the calculation)
Applicant's summary and conclusion
- Executive summary:
The test item 2-Propylheptyl methacrylate was not a skin sensitiser under the test conditions of this study.
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