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EC number: 429-580-7 | CAS number: -
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 06 2000 - June 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No LLNA study was conducted as an in vivo study according to OCED 406 was conducted in 2000, before the first version of the LLNA (OECD 429) was issued in 2002.
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
- Females nulliparous and non-pregnant: not specified
- 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.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-27
- Humidity (%): 46-84
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Remarks:
- or Sodium chloride (NaCl) solution with Freund's complete adjuvant (FCA)
- Concentration / amount:
- Amount: 0.1 mL
liqiud paraffin: 5 g test material/L
NaCl+FCA: 5 g test material/L - Day(s)/duration:
- on day 1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Amount: 1 mL
50 g test material/L liquid paraffin - Day(s)/duration:
- on day 8, treatement for 48 h
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Amount: 0.5 mL
10 g test material/L liquid paraffin - Day(s)/duration:
- on day 22, treatement for 24 h
- 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/L
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day of challenge: day 22
- Exposure period: 24 h
- 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
Other:
During the induction phase, the guinea pigs were examined on days 2, 3, 7, 11, 12, 15 and 22 for local skin reactions.
The behavior and general condition of all animals were monitored daily.
The body weight of the guinea pigs was determined prior to the start of the experimental part, on days 8, 15, 22, and at the end of the experimental part. - Challenge controls:
- Data from the GLP study with Experimental part: April 11 until May 05, 2000.
- Positive control substance(s):
- yes
- Remarks:
- Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Positive control data from a different GLP study showed a rate of skin sensitisation reaction of 80 %.
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
- Remarks on result:
- no indication of skin sensitisation
- 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
- Remarks on result:
- no indication of skin sensitisation
- 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
- Remarks on result:
- no indication of skin sensitisation
- 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
- Remarks on result:
- no indication of skin sensitisation
- 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
Any other information on results incl. tables
Results of the pre-test:
Vehicle: Liquid paraffin
Intradermal induction: 5 g test material/L: slightly irritant
Topical induction: 50 g test material/L: slightly irritant
Topical challenge: 10 g test material/L: not irritant
Findings in the induction phase
After intradermal injection, the common signs of irritation after injection of Freund's complete adjuvant were observed. The injection sites were swollen and red, later on, scabs developed. The median with test material treated injection sites were swollen and red.
After removal of the patches, swollen application sites and scabs were observed at the application sites.
Findings after challenge
Group 1: negative control group
After challenge with liquid paraffin, no erythema or edema were observed at the readings.
Single treatment was performed with the test material (10 g/L liquid paraffin) to exclude the primary irritation potential of the test material. No positive reactions were observed in the treated areas at any reading.
Group 2: test material group
The challenge was performed on the right flank with liquid paraffin and with the test material preparation in liquid paraffin.
No positive reactions were observed in the areas treated with liquid paraffin at any reading.
After challenge with the test material (10 g/L preparation in liquid paraffin) no positive skin reactions were observed at the readings. This results in 0 % positive reactions at challenge.
Clinical findings and mortality
The clinical behavior of the guinea pigs was normal during the experimental part. All animals survived the experimental part.
Body weight
The body weight development corresponded to that of the animals of the vehicle group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the given experimental conditions, the test material induced no reactions and showed no skin sensitisation potential.
- Executive summary:
An in vivo study in guinea pigs according to OECD 406 was conducted to evaluate the skin sensitsation potential of the test substance. 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 paraffin (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. Based on the study results the test substance showed no skin sensitization potential.
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