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Diss Factsheets
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EC number: 203-427-2 | CAS number: 106-72-9
- 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
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 20 December 2016 and 24 January 2017.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2,6-dimethylhept-5-enal
- EC Number:
- 203-427-2
- EC Name:
- 2,6-dimethylhept-5-enal
- Cas Number:
- 106-72-9
- Molecular formula:
- C9H16O
- IUPAC Name:
- 2,6-dimethylhept-5-enal
- Reference substance name:
- 6-methylhept-5-en-2-one
- EC Number:
- 203-816-7
- EC Name:
- 6-methylhept-5-en-2-one
- Cas Number:
- 110-93-0
- Molecular formula:
- C8H14O
- IUPAC Name:
- 6-methylhept-5-en-2-one
- Reference substance name:
- (1R,2R,5R)-2-methyl-5-(prop-1-en-2-yl)cyclopentan-1-ol
- Cas Number:
- 83059-39-6
- Molecular formula:
- C9H16O
- IUPAC Name:
- (1R,2R,5R)-2-methyl-5-(prop-1-en-2-yl)cyclopentan-1-ol
- Reference substance name:
- (1R,2S,5R)-2-methyl-5-(prop-1-en-2-yl)cyclopentan-1-ol
- Cas Number:
- 83026-65-7
- Molecular formula:
- C9H16O
- IUPAC Name:
- (1R,2S,5R)-2-methyl-5-(prop-1-en-2-yl)cyclopentan-1-ol
- Reference substance name:
- 2-(3-methylcyclopent-2-en-1-yl)propan-2-ol
- Molecular formula:
- C9H16O
- IUPAC Name:
- 2-(3-methylcyclopent-2-en-1-yl)propan-2-ol
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
- Specific details on test material used for the study:
- Identification: Melonal
Appearance: Colourless to pale yellow liquid
Batch: PE0016691
In vitro test system
- Details on the study design:
- N/A
In chemico test system
- Details on the study design:
- N/A
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Mouse, CBA/J strain, inbred, SPF-Quality.
Recognized by the international guidelines as the recommended test system (e.g. OECD, EC, EPA).
Source: Janvier, Le Genest-Saint-Isle, France
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 or 100%
- No. of animals per dose:
- 5
- Details on study design:
- Three groups of five animals were treated with one test item concentration per group. The highest test item concentration was selected from the pre-screen test.
One group of five animals was treated with the vehicle.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 2.1
- Test group / Remarks:
- 25% Concentration
- Parameter:
- SI
- Value:
- 4.6
- Test group / Remarks:
- 50% Concentration
- Parameter:
- SI
- Value:
- 5.5
- Test group / Remarks:
- 100% Concentration
- Key result
- Parameter:
- EC3
- Value:
- 34
Any other information on results incl. tables
Pre-screen Test
Very slight erythema was noted for the animals treated at 50% and 100% between Day 1 and Day 6.
Variations in ear thickness during the observation period were less than 25% from Day 1 pre-dose values.
Based on these results, the highest test item concentration selected for the main study was a 100% concentration.
Main Study
Skin Reactions / Irritation
The very slight erythema of the ears as shown by several animals treated at 50% and all animals treated at 100% on Days 2 and/or 3 was considered not to have a toxicologically significant effect on the activity of the nodes.
Systemic Toxicity
No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Macroscopic Examination of the Auricular Lymph Nodes and Surrounding Area
All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted for any of the animals.
Radioactivity Measurements and SI Values
Mean DPM/animal values for the experimental groups treated with test item concentrations 25, 50 and 100% were 990, 2144 and 2591 DPM, respectively. The mean DPM/animal value for the vehicle control group was 467 DPM. The SI values calculated for the test item concentrations 25, 50 and 100% were 2.1, 4.6 and 5.5, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The SI values calculated for the test item concentrations 25, 50 and 100% were 2.1, 4.6 and 5.5, respectively.
These results indicate that the test item could elicit a SI ≥ 3. The data showed a dose-response and an EC3 value (the estimated test item concentration that will give a SI =3) of 34% was calculated.
The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at Charles River Den Bosch is an appropriate model for testing for contact hypersensitivity (see Appendix 2 of study report). - Executive summary:
The SI values calculated for the test item concentrations 25, 50 and 100% were 2.1, 4.6 and 5.5, respectively.
These results indicate that the test item could elicit a SI ≥ 3. The data showed a dose-response and an EC3 value (the estimated test item concentration that will give a SI =3) of 34% was calculated.
The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at Charles River Den Bosch is an appropriate model for testing for contact hypersensitivity.
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