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EC number: 604-582-2 | CAS number: 1472-93-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 10 January 2012 to 24 January 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across from GLP guideline study. Read-across justification: A comparison target substance (9DDAME) and the read-across substance (9DAME) shows that the two substances share structural similarities, increasing from a chain length of C10 to C12 with similar functional groups and also have ‘mechanistic action’ similarities.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection 2011-07-19 to 2011-07-21; Date of signature 2011-08-31
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- methyl 9-decenoate
- EC Number:
- 662-772-0
- Cas Number:
- 25601-41-6
- Molecular formula:
- C11H20O2
- IUPAC Name:
- methyl 9-decenoate
- Details on test material:
- - Name of test material (as cited in study report): 9-decenoic acid, methyl ester (9DAME)
- Physical state: Clear colourless liquid
- Analytical purity: 99%
- Lot/batch No.: 184-109
- Date received: 2011-04-01
- Storage conditions: room temperature in the dark under nitrogen
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- This vehicle was chosen as it produced the most suitable formulation at the required concentration.
- Concentration:
- 25%, 50% and 100% v/v in acetone/olive oil 4:1.
- No. of animals per dose:
- 4 animals per dose
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The stimulation index was 4.05. Therefore, ?-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitiser under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.61
- Remarks on result:
- other: Concentration (% v/v) in acetone/ olive oil 4:1, 25 %: 1.61
- Parameter:
- SI
- Value:
- 3.02
- Remarks on result:
- other: Concentration (% v/v) in acetone/ olive oil 4:1, 50 %: 3.02
- Parameter:
- SI
- Value:
- 2.42
- Remarks on result:
- other: Concentration (% v/v) in acetone/ olive oil 4:1, 100 %: 2.42
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- The radioactive disintegrations per minute per lymph node are as follows: - Concentration (% v/v) in acetone/ olive oil 4:1, Vehicle: 12665.97 - Concentration (% v/v) in acetone/ olive oil 4:1, 25 %: 20382.35 - Concentration (% v/v) in acetone/ olive oil 4:1, 50 %: 38258.42 - Concentration (% v/v) in acetone/ olive oil 4:1, 100 %: 30617.01
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item returned a borderline response under the conditions of the test. An expert review of these study results (Basketter, 2012) indicated that 9-decenoic acid, methyl ester (9DAME) does not contain any structural alerts for reactivity associated with skin sensitisation and is a long chain unsaturated fatty acid. Published work has indicated that unsaturated fatty acids have the potential to generate false positive results in the LLNA. Several long chain unsaturated fatty acids, such as oleic acid, have proven to be positive in the LLNA but were clear negatives in guinea pig maximisation test conducted in parallel, an outcome which was consistent with their absence of skin sensitising effects in humans.
Based upon the above considerations, the very borderline nature of the single positive result and the absence of a dose response in this test it is feasible that a false positive result may have been obtained and hence 9-decenoic acid, methyl ester (9DAME) is not considered to be a skin sensitiser. - Executive summary:
A study was performed to assess the skin sensitisation potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear, according to OECD Guideline 429, in compliance with GLP. Three groups, each of four animals, were treated with 50 μL (25 μL per ear) of the undiluted test item (100%) or the test item as a solution in acetone/olive oil 4:1 at concentrations of 50% or 25% v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone. The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group were 1.6.1, 3.02 and 2.42 for concentrations of 25%, 50% and 100%, respectively. The test item returned a borderline response under the conditions of
the test. An expert review of these study results (Basketter, 2012) indicated that 9-decenoic acid, methyl ester (9DAME) does not contain any structural alerts for reactivity associated with skin sensitisation and is a long chain unsaturated fatty acid. Published work has indicated that unsaturated fatty acids have the potential to generate false positive results in the LLNA. Several long chain unsaturated fatty acids, such as oleic acid, have proven to be positive in the LLNA but were clear negatives in guinea pig maximisation test conducted in parallel, an outcome which was consistent with their absence of skin sensitising effects in humans. Based upon the above considerations, the very borderline nature of the single positive result and the absence of a dose response in this test it is feasible that a false positive result may have been obtained and hence 9-decenoic acid, methyl ester (9DAME) is not considered to be a skin sensitiser (Harlan Laboratories Ltd, 2012).
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