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EC number: 604-593-2 | CAS number: 147622-85-3
- 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:
- 2001-03-02 to 2001-05-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 07-1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed in 2001
Test material
- Reference substance name:
- 4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone
- EC Number:
- 604-593-2
- Cas Number:
- 147622-85-3
- Molecular formula:
- C18 H22 F2 O
- IUPAC Name:
- 4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: 315 - 384 g
- Housing: two animals per Makrolon cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 52 - 58
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: Days 1 to 25
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- Group 1 (control): cranial 0.1 mL FCA + NaCl solution; medial 0.1 mL vehicle; caudal 0.1 mL FCA + NaCl solution
Group 2 (test item): cranial 0.1 mL FCA + NaCl solution; medial 0.1 mL test item (5 g/L vehicle); caudal 0.1 mL FCA with test item + NaCl solution (5 g test item/L preparation) - Day(s)/duration:
- 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:
- Filter patch soaked with 1 mL of the test item preparation or vehicle.
Group 1: liquid paraffin
Group 2: Test item (200 g/L vehicle) - Day(s)/duration:
- day 8 (over 48 hours)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Filter paper soaked with 0.5 mL of the test item preparation or vehicle
Group 1: liquid paraffin
Group 2: Test item (10 g/L vehicle) - Day(s)/duration:
- day 22 (over 24 hours)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pretest: 5 f
Group 1 (vehicle controls): 10 f
Group 2 (test item): 20 f - Details on study design:
- During the induction phase, the guinea pigs were examined on days 2, 3, 7, 11, 12, 15, and 22 of the experimental part for local skin reactions.
Behavior and general condition of all animals were monitored daily.
The challenge sites were investigated for reactions 48 hours after start of the challenge. Further inspections followed 72 hours after start of the challenge.
Body weights were determined prior to the start of the experimental part, on experimental days 8, 15, 22, and at the end of the experimental part. - Positive control substance(s):
- yes
- Remarks:
- The control was carried out with alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- see above
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: 1st and 2nd reading (48 and 72 hrs after challenge)
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 1st and 2nd reading (48 and 72 hrs after challenge)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Study design
The test item was evaluated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). 10 female guinea pigs in the negative control group (group 1) treated with the vehicle liquid paraffin and 20 females in the test material group (group 2) were investigated. Induction included intradermal injection of test material preparation (5 g/L with and without FCA) on experimental day 1, and topical application of test material preparation (200 g/L) on day 8 of the experimental part. Challenge by topical application of the test material preparation (10 g/L) was performed two weeks after topical induction.
Results
After challenge no positive reactions in the test material treated skin sites at both readings were seen.
Conclusion
Under the given experimental conditions, the test item showed no positive responders and has not to be classified as a sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the given experimental conditions, the test item showed no positive responders and has not to be classified as a sensitizer.
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