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EC number: 251-717-2 | CAS number: 33885-51-7
- 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
- Study period:
- The study was conducted between 15 June 2009 and 14 July 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Historical in vivo previously available before new regulation requirements came into force
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 6,6-dimethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde
- EC Number:
- 251-717-2
- EC Name:
- 6,6-dimethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde
- Cas Number:
- 33885-51-7
- Molecular formula:
- C12H18O
- IUPAC Name:
- 3-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl)propanal
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Jackson Laboratories, Bar Harbor, ME 04609
- Age at study initiation: 8 weeks
- Weight at study initiation: 19 to 23 g
- Housing: 5 animals/cage (randomly allocated)
- Diet (e.g. ad libitum): ad libitum (Harlan Teklad Certified Rodent Chow 7012C)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 44-62
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: Ethanol/diethyl phthalate 1:3
- Concentration:
- 2.5 %, 5%, 10%, 25% or 50% v/v in EtOH/DEP 1:3
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
Test Item Administration
Groups of five mice were treated with the test item at concentrations of 2.5 %, 5%, 10%, 25% or 50% v/v in EtOH/DEP. No justification on the choice of vehicle is provided. The doses were chosen on the basis of avoiding systemic toxicity and overtly induced skin irritation, according to reported uses of the test material. The mice were treated by daily application of 25 µl of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of five mice received the vehicle alone in the same manner.
The positive control animals were similarly treated to the test animals except that 25 µl of the positive control item, α Hexylcinnamaldehyde, at a concentration of 5%, 15% and 35% v/v in ethanol/diethyl phthalate 1:3 was applied to the dorsal surface of each ear.
3H-Methyl Thymidine Administration
On day 6, all mice were injected via the tail vein with 250 µl of phosphate buffered saline (PBS) containing 3H methyl thymidine (3HTdR:80µCi/ml, specific activity 2.0 Ci/mmol, ARC UK Ltd) giving a total of 20 µCi to each mouse.
Observations
Clinical Observations: All animals were observed before and after dosing, and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded. The animals were also examined daily for erythema and edema on the site of application.
Bodyweights: The bodyweight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).
Terminal Procedures
Termination: Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation. For each individual animal of each group the draining auricular lymph nodes were excised and processed.
Preparation of Single Cell Suspension: A single cell suspension of the lymph node cells for each individual animal was prepared. The lymph node cells were rinsed with PBS and precipitated with 5% trichloroacetic acid during night. The lymph node cells suspension was transferred to a centrifuge tube and thereafter, the pellets were resuspended in 1 ml TCA and transferred to scintillation fluid vials for the measurement of the radioactive material. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate. Increases in the radioactivity compared to the vehicle control were recorded. Individual DPM values were analyzed with log values. Dunett's test was used to determine significance when required. The EC3 was calculated as follows:
EC3=c+[(3-d)/(b-d)](a-c),
data points between the SI=3 lie in the coordinates (a,b) and (c,d)
Results and discussion
- Positive control results:
- The positive control item, α-Hexylcinnamaldehyde, gave a Stimulation Index of greater than 3 when tested at a concentration of 25 % v/v.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- 25
- Parameter:
- SI
- Value:
- 1.8
- Remarks on result:
- other: 2.5%
- Parameter:
- SI
- Value:
- 1.1
- Remarks on result:
- other: 5%
- Parameter:
- SI
- Value:
- 1.7
- Remarks on result:
- other: 10%
- Parameter:
- SI
- Value:
- 3
- Remarks on result:
- other: 25%
- Parameter:
- SI
- Value:
- 4.5
- Remarks on result:
- other: 50%
- Cellular proliferation data / Observations:
- No erythema or edema was noted. There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Substance is a skin sensitiser (1B)
- Remarks:
- in accordance with EU CLP (1272/2008 and its amendments)
- Conclusions:
- The test item was considered to be a sensitiser under the conditions of the test and resulted in an EC3 value of 25%.
- Executive summary:
The skin sensitisation potential of the test substance has been tested according to OECD TG 429 (Local Lymph Node Assay). At 2.5, 5, 10, 25 and 50% the substance showed SI values of 1.8, 1.1, 1.7, 3.0 and 4.5, respectively. An EC3 value of 25% was derived. The substance was found to be a skin sensitiser under the conditions of this test.
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