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Diss Factsheets
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EC number: 202-943-5 | CAS number: 101-43-9
- 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
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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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Cyclohexyl methacrylate
- EC Number:
- 202-943-5
- EC Name:
- Cyclohexyl methacrylate
- Cas Number:
- 101-43-9
- Molecular formula:
- C10H16O2
- IUPAC Name:
- cyclohexyl 2-methylprop-2-enoate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, FRG
- Age at study initiation: about 8 weeks
- Weight at study initiation: 16.9 g - 20.9 g
- Housing: single housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 29 days before the first test substance application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 -70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: acetone
- Concentration:
- 3, 10, 30 %
- No. of animals per dose:
- 6
- Details on study design:
- The study comprised three treatment groups and a vehicle control group.
Each group consisted of 6 mice. A check for dead or moribund animals was made twice each workday and once on Saturdays, Sundays and on public holidays.
No detailed clinical examination of the individual animals was performed but any obvious signs of systemic toxicity and/or local inflammation at the application sites were noted in the raw data.
Body weights of the individual animals were determined on study day 0 prior to the first application and on day 5 prior to the sacrifice of the animal.
Percutaneous application is simulating dermal contact with the compound which is possible to occur under practical use conditions.
Application volume: 25 µL per ear
Site of application: dorsal part of both ears
Frequency of application: 3 consecutive applications (day 0- day 2) to the same application site
The animals were sacrificed on study day 5 by cervical dislocation.
Immediately after the death of each animal a circular piece of tissue (diameter 0.8 cm) was punched out of the apical part of each ear. The weight of the pooled punches wasdetermined for each animal.
Immediately after removal of the ear punches the left and right auricular lymph nodes were dissected. The weight of the pooled lymph nodes from both sides was determined for each animal.
A concurrent positive control (reliability check) with a known sensitizer was not included into this study.
Studies using the positive control substance Alpha-Hexylcinnamaldehyde,techn. 85% are performed twice a year in the laboratory in order to show that the test system is able to detect sensitizing compounds under the test conditions chosen.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- other: Lymph node Weight Index
- Value:
- 1.29
- Test group / Remarks:
- 3 % in acetone
- Key result
- Parameter:
- other: Cell count Index
- Value:
- 1.48
- Test group / Remarks:
- 3 % in acetone
- Key result
- Parameter:
- other: Ear Weight Index
- Value:
- 0.95
- Test group / Remarks:
- 3 % in acetone
- Parameter:
- other: Lymph node Weight Index
- Value:
- 1.47
- Test group / Remarks:
- 10 % in acetone
- Parameter:
- other: Cell count Index
- Value:
- 1.68
- Test group / Remarks:
- 10 % in acetone
- Parameter:
- other: Ear Weight Index
- Value:
- 1.05
- Test group / Remarks:
- 10 % in acetone
- Parameter:
- other: Lymph node Weight Index
- Value:
- 1.78
- Test group / Remarks:
- 30 % in acetone
- Parameter:
- other: Cell count Index
- Value:
- 1.93
- Test group / Remarks:
- 30 % in acetone
- Parameter:
- other: Ear Weight Index
- Value:
- 1.18
- Test group / Remarks:
- 30 % in acetone
Any other information on results incl. tables
No signs of systemic toxicity were noticed. The test substance induced a statistically significant and biologically relevant response of the auricular lymph nodes when applied as 3 %, 10 % or 30 % preparations in acetone. The concentration dependent statistically significant increases in ear weights induced by the test substance when applied as 10 % and 30 % preparation indicate some irritation of the ear skins.
In conclusion, Cyclohexylmethacrylat has a skin sensitizing effect in the Murine Local Lymph Node Assay. The threshold concentration for sensitization induction was < 3 % under the test conditions chosen.
Based on the available data, Cyclohexylmethacrylate is a skin sensitizer of strong potency. However, taking into account the observed irritating effects on the ears, and the missing dose-dependency of the lymph node proliferation, the sensitising effect cannot be clearly discriminated from at least partly possible lymph node proliferation based on skin irritancy.
Test group |
Treatment |
Lymph node Weight Index |
Cell count Index |
Ear Weight Index |
1 |
Vehicle acetone |
1.00 |
1.00 |
1.00 |
2 |
3 % in acetone |
1.29 ## |
1.48 ## |
0.95 |
3 |
10 % in acetone |
1.47 ## |
1.68 ## |
1.05 ## |
4 |
30 % in acetone |
1.78 ## |
1.93 ## |
1.18 ## |
The statistical evaluations were performed using the WILCOXON-test (# for p<= 0.05, ## for p<= 0.01
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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.
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