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Diss Factsheets
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EC number: 203-973-1 | CAS number: 112-45-8
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- The Freund's Complete Adjuvant Test and the Open Epicutaneous Test- A Complementary Test Procedure for Realistic Assessment of Allergenic Potential
- Author:
- G. Klecak
- Year:
- 1 985
- Bibliographic source:
- Curr. Probl. Derm., vo1.14, pp.152-171 (Karger, Basel 1985)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- An Open Epicutaneous Test (OET) was performed on guinea pigs to assess the skin sensitization potential of test chemical
- GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- Undec-10-enal
- EC Number:
- 203-973-1
- EC Name:
- Undec-10-enal
- Cas Number:
- 112-45-8
- Molecular formula:
- C11H20O
- IUPAC Name:
- undec-10-enal
- Details on test material:
- IUPAC name:Aldehyde C11 Undecyclenic
Mol. formula: C11H20O
Molecular Weight: 168.278
Smiles: C(CCCCC=O)CCCC=C
InChI:1S/C11H20O/c1-2-3-4-5-6-7-8-9-10-11-12/h2,11H,1,3-10H2
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- - Weight at study initiation: 300-450g
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol, acetone, H20, petroleum, PEG and/or other suitable vehicles
- Concentration / amount:
- Concentration:1%
Amount: 0.1ml - Day(s)/duration:
- 3 weeks (0-21 days)
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol, acetone, H20, petroleum, PEG and/or other suitable vehicles
- Concentration / amount:
- Concentration:1%
Amount: 0.025ml - Day(s)/duration:
- 72 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 6–8 male and female guinea pigs
- Details on study design:
- RANGE FINDING TESTS: The Pretest was performed to establish the primary irritating threshold concentration of test substance. For this, a single application of 0.025 ml of each test concentration (e.g, 100, 30, 10 and 3%) is simultaneously performed on one of the areas measuring 2 cm2 of the flank skin previously clipped and marked with a circular stamp. Reactions are read 24 h after the application of the test material. On the basis of preliminary study, the maximal non-irritating concentration selected was 1%. Thus the sensitization test was conducted at a dose of 1% of test chemical.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Exposure period:24 hours
- Test groups:6-8 guinea pigs
- Control group:3 guinea pigs
- Site: an area measuring 8 cm2 on the clipped flank skin of the guinea pigs
- Frequency of applications: The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks
- Duration: 21 days (3 weeks)
- Concentrations: 1% in vehicle.
Amount: 0.1ml
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: on days 21 and 35
- Exposure period:24 hours
- Test groups: 6-8 guinea pigs
- Control group: 3 guinea pigs
- Site: contralateral flank measuring 2 cm2
- Concentrations: Concentration:1%
Amount: 0.025ml
- Evaluation (hr after challenge): 24,48 and/or 72h. - Challenge controls:
- The 10 controls were either left untreated or treated with 0.1 ml aliquot of the vehicle for 21 days
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1% (0.025ml)
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- No signs of dermal sensitization reactions were observed.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No signs of dermal sensitization reactions were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test chemical was considered to be not sensitizing on skin of guinea pigs at concentration of 1% in an Open Epicutaneous Test (OET).
- Executive summary:
An Open Epicutaneous Test (OET) was performed on guinea pigs to assess the skin sensitization potential of test chemical. The Pretest was performed to establish the primary irritating threshold concentration of test substance. For this, a single application of 0.025 ml of each test concentration (e.g, 100, 30, 10 and 3%) is simultaneously performed on one of the areas measuring 2 cm2 of the flank skin previously clipped and marked with a circular stamp. Reactions are read 24 h after the application of the test material. On the basis of preliminary study, the maximal non-irritating concentration selected was 1%. Thus the sensitization test was conducted at a dose of 1% of test chemical.
On day 1 during induction, 0.1 ml of test chemical was applied at concentrations of 1% in vehicle to an area measuring 8 cm2 on the clipped flank skin of the guinea pigs. The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, usually on the same skin sites. The application sites were left uncovered and the reactions, if continuous daily applications were performed, can be read 24 h after each application, or at the end of each week. To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days, as well as 10 untreated, or only pretreated with the vehicle, controls are tested on days 21 and 35 on the contralateral flank with the test material. This test was performed by applying with a pipette 0.025 ml of each concentration to skin areas measuring 2 cm2. The reactions were read after 24, 48 and/or 72h.
It was observed that none of the guinea pigs induced contact sensitization at challenge concentration of 1%.Thus, the test chemical was considered to be not sensitizing on skin of guinea pigs at concentration of 1% in an Open Epicutaneous Test (OET).
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