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EC number: 617-606-1 | CAS number: 84656-75-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jun 06 2000 - Jun 30 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo assay OECD 406 was performed before the OECD 429 assay was mandatory.
Test material
- Reference substance name:
- (trans(trans))-4'-vinyl-4-(4-methylphenyl)bicyclohexyl
- EC Number:
- 439-730-3
- EC Name:
- (trans(trans))-4'-vinyl-4-(4-methylphenyl)bicyclohexyl
- Cas Number:
- 155041-85-3
- Molecular formula:
- Hill formula: C21H30 CAS formula: C21H30
- IUPAC Name:
- (trans(trans))-4'-Vinyl-4-(4-methylphenyl)bicyclohexyl
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: about 6 weeks (beginning of treatment)
- Weight at study initiation: 372 g (range from 316 g to 415 g)
- Housing: single Makrolon cage type with a shelter placed on mobile racksbedding conventional softwood granulate bedding change twice weekly
- Diet: ad libitum; exclusive diet for guinea pigs No. 845, Eberle Nafag
- Water: ad libitum; community tap water from Makrolon drinking bottles
- Acclimation period: At least 7 days prior to the start of dosing under test conditions after health examination. The guinea pigs were identified by color mark.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 27 °C
- Humidity: 46 - 84 %
- Air changes (per hr): not specified
- Photoperiod: 12 hours light / 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5 g/L
- Day(s)/duration:
- on Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50 g/L
- Day(s)/duration:
- on Day 8/ 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 10 g/L
- Day(s)/duration:
- on Day 22/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Total: 35 females
Pre-test: 5 females
Control group: 10 females (negative control)
Test group 20 females (test material) - Details on study design:
- RANGE FINDING TESTS:
- intradermal injection: 0, 1, 5, 10, 25, 50 g/L given to one animal
- topical applications, no pretreatment: 1, 10, 50, 100, 200, 400 g/L given to four animals
- topical applications, pretreatment with FCA: 1, 5, 10, 25 g/L given to two animals
MAIN STUDY
A1.
INDUCTION EXPOSURE (intradermal injection)
- No. of exposures: 6 injections of 0.1 mL each, three on each side of the spinal column)
- Test groups: 0.1 mL FCA + NaCl, 5g/L test item ad liquid paraffin, FCA + 5 g/L test item + NaCl
- Control group: 0.1 mL FCA + NaCl, 0.1 mL liquid paraffin, 0.1 mL FCA + NaCl
- Site: cranial, medial, caudal- Frequency of applications: single
- Concentrations: 5 g/L
A2.
INDUCTION EXPOSURE (topical application)
- No. of exposures: one week after injection (A1) single topical application of a filter plate soaked with either test solution, or vehicle
- Test groups: Test item (50 g/L) in liquid paraffin
- Control group: liquid paraffin- Site: cranial, medial, caudal (8 cm^2)
- Frequency of applications: single
- Duration: 48 h, occlusive
- Concentrations: 50 g/LB.
CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 1d
- Exposure period: 2 weeks after topical application
- Test groups: 10 g/L test item
- Control group: liquid paraffin
- Site: cranial, medial, caudal (4 cm^2)
- Concentrations: 10 g/L
- Evaluation (hr after challenge): 48 and 72 h - Challenge controls:
- Data from the GLP study. Experimental part: April 11 until May 05, 2000.
- Positive control substance(s):
- yes
- Remarks:
- Hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no signs of toxicity
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of toxicity
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no signs of toxicity
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 10 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of toxicity
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 g/L
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 10 g/L
- No. with + reactions:
- 4
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the given experimental conditions, the test material induced no reactions. According to the Regulation (EC) No 1272/2008, the test material is not to be classified as a skin sensitizer.
- Executive summary:
The purpose of this assay was to identify the contact allergenic potential of the test item in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man. The test item as investigated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). 10 females were treated with the vehicles liquid paraffin (group 1) and 20 females were treated with the test material (group 2). The induction included intradermal injection of test material preparation in liquid paraffin (5 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation in liquid paraffine (50 g/L) for 48 hours on experimental day 8. The challenge was performed by topical application of the test material preparation (10 g/L) for 24 hours, two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment. After challenge no positive reactions were seen 48 or 72 hours after treatment with the test material. Under the given experimental conditions, the test material induced no reactions. Therefore, the test material is not considered to be a skin sensitizer.
It should be noted that this study was already evaluated by the German competent authority BAUA during the registration under ChemG. BAUA agreed with the scientific interpretation of the results presented here.
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.
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