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EC number: 460-490-0 | CAS number: 477218-42-1
- 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:
- 04-07-2005 to 26-08-2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: CTFA Safety Testing Guidelines
- Version / remarks:
- The Cosmetic, Toiletry and Fragrance Association, Inc., Washington, D. C. 20036; "Guidelines for Evaluating Photodermatitis", 1991.
- Qualifier:
- according to guideline
- Guideline:
- other: Klecak G., Geleick H. and Frey J.R. (1977). Screening of fragrance materials for allergenicity in the guinea pig. J. Soc. Cosmet. Chem. 28: 53-64.
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: DERMATOTOXICOLOGY, Ed. F.N. Marzulli & H.l. Maibach, 1982. Hemisphere Publ. Co., Chapter 9, Author: G. Klecak. pp. 213-219
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: November 2002 ; signature: March 2003
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- Study conducted prior to Regulation (EC) 1907/2006 and/or Regulation (EC) 1272/2008 publication and implementation.
Test material
- Reference substance name:
- -
- EC Number:
- 460-490-0
- EC Name:
- -
- Cas Number:
- 477218-42-1
- Molecular formula:
- C18H32O3
- IUPAC Name:
- 2-[(1S)-1-[(1R)-3,3-dimethylcyclohexyl]ethoxy]-2-methylpropyl cyclopropanecarboxylate; 2-[(1S)-1-[(1S)-3,3-dimethylcyclohexyl]ethoxy]-2-methylpropyl cyclopropanecarboxylate
- Test material form:
- liquid
- Details on test material:
- Physical state: Liquid
- Storage condition of test material: at room temperature (range of 20 ± 5 °C), light protected.
- Other: colourless liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- CRL:(HA)BR, SPF
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Recognised supplier
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 5-6 weeks.
- Weight at study initiation: 336 – 372 g
- Housing: individually in stainless steel suspended cages
- Diet (e.g. ad libitum): Standard maintenance/breeding diet for guinea pigs from a recognised supplier (details in the full study report).
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: The acclimatization period was at least 5 days before the start of treatment under laboratory conditions; identical to the test. One group (group 4) had no acclimatisation.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3 °C
- Humidity (%): 30 – 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12-hour light (with music) / 12-hour dark
IN-LIFE DATES: From: To: 29-06-2005 to 04-08-2005
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- - Topical: 0% test material (control group)
- Day(s)/duration:
- Day 1 - 26
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- - Topical: 25% test material
- Day(s)/duration:
- Day 1 - 26
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- - Topical: 50% test material
- Day(s)/duration:
- Day 1 - 26
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- - Topical: 75% test material
- Day(s)/duration:
- Day 1 - 26
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- - Topical: 100%
- Day(s)/duration:
- Day 1 - 26
- Adequacy of induction:
- highest technically applicable concentration used
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- - Challenge: 5%
- Day(s)/duration:
- day 29
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- - Challenge: 10%
- Day(s)/duration:
- day 29
- No.:
- #3
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- - Challenge: 15%
- Day(s)/duration:
- day 29
- No.:
- #4
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- - Challenge: 25%
- Day(s)/duration:
- day 29
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 6 ; Control group: 6
- Details on study design:
- RANGE FINDING TESTS:
A preliminary irritation study was conducted in order to select test substance concentrations to be used in the main study. By cutaneous route: Tested concentrations: 100%, 75%, 50%, and 25% (w/w). Cutaneous reactions were evaluated approximately 24 and 48 hours after the application.
At 24 and 48 hours: No non-irritating dose was observed. The minimal irritating concentration of the concentrations tested was 25%. Final concentrations for definitive testing based on preliminary irritation study:
- Induction: 0.1 mL of test item, undiluted (100%) and diluted to 25%, 50% and 75% in PEG 300.
- Control: 0.1 mL PEG 300 only.
- Challenge: All animals previously treated in induction, as well as control animals, were treated in the same procedure as the induction period, but with a 5%, 10%, 15% or 25% solution in PEG 300.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: epidermal, daily (5 times per week) for 4 weeks.
- Exposure period: Days 1-26.
- Test groups: I: Control group (PEG 300); II: Test Group 1 (induced with 25% solution); III: Test Group 2 (induced with 50% solution); IV: Test Group 3 (induced with 75% solution); V: Test Group 4 (induced with undiluted test item).
- Control group: PEG 300 (vehicle only).
- Site: epidermal application (clipped right flank);
- Frequency of applications:
- Duration: Daily application (5 days/week) over days 1-26.
- Concentrations: Topical induction: 0.1 mL test item, undiluted and diluted to 25%, 50% and 75% in PEG 300.
The control group were treated as described for the experimental group except that, instead of the test item, the vehicle was administered.
B. CHALLENGE EXPOSURE
- No. of exposures: 1 initial challenge
- Day(s) of challenge: day 29 (topical challenge)
- Exposure period: Days 1-26 (induction) ; Day 29 (topical challenge). The treated sites were assessed for challenge reactions 24, 48 and 72 hours after challenge procedure.
- Test groups: 1 control group, and 4 test groups, all challenged.
- Control group: 1; vehicle only application instead of induction with test item.
- Site: One flank (clipped)
- Concentrations: 5%, 10%, 15%, 25% in PEG 300.
- Evaluation (hr after challenge): 24, 48 and 72 hours after challenge (Day 30, 31, 32).
The control group were treated as described for the experimental group except that induction exposure had been with the vehicle rather than the test item.
OTHER: Mortality, toxicity and body weights along with irritation were examined as part of the study - Challenge controls:
- negative control group consisting of 6 females, consistent with the main study (the difference being that instead of the test item only the vehicle was administered during induction)
- Positive control substance(s):
- yes
- Remarks:
- Alpha-hexylcinnamaldehyde (HCA)
Results and discussion
- Positive control results:
- A reliability check was performed (presented in the full study report) to check the sensitivity of the test system and the reliability of the experimental techniques used. The study used the same conditions as the main study using alpha-hexylcinnamaldehyde (induced topically with 5%, 10% and 15% solutions in PEG 300, and challenged with 0.1 - 10% challenge concentrations) as positive control.
The highest challenge concentration of 10% chosen as well as the concentration of 5% were irritant as revealed by the positive challenge results obtained with the control group. The threshold for induction of skin sensitisation was approximately 5%. No sensitisation was induced with 1%, 0.3% and 0.1%. The challenge threshold was dependent on the induction concentration used. The declining frequency of positives indicated that the threshold was achieved at 3%.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0% (control group); challenge concentration 5%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0% (control group); challenge concentration 10%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0% (control group); challenge concentration 15%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0% (control group); challenge concentration 25%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 25%; challenge concentration 5%
- No. with + reactions:
- 2
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 25%; challenge concentration 10%
- No. with + reactions:
- 4
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 25%; challenge concentration 15%
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 25%; challenge concentration 25%
- No. with + reactions:
- 5
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 50%; challenge concentration 5%
- No. with + reactions:
- 2
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 50%; challenge concentration 10%
- No. with + reactions:
- 2
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 50%; challenge concentration 15%
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 50%; challenge concentration 25%
- No. with + reactions:
- 2
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 75%; challenge concentration 5%
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 75%; challenge concentration 10%
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 75%; challenge concentration 15%
- No. with + reactions:
- 5
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 75%; challenge concentration 25%
- No. with + reactions:
- 5
- Total no. in group:
- 6
- Clinical observations:
- No clinical observations noted.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 100%; challenge concentration 5%
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Clinical observations:
- One animal was humanely terminated on day 1, due to emaciation and diarrhoea. No clinical observations were noted in the survivors
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 100%; challenge concentration 10%
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Clinical observations:
- One animal was humanely terminated on day 1, due to emaciation and diarrhoea. No clinical observations were noted in the survivors
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 100%; challenge concentration 15%
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Clinical observations:
- One animal was humanely terminated on day 1, due to emaciation and diarrhoea. No clinical observations were noted in the survivors
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction concentration 100%; challenge concentration 25%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- One animal was humanely terminated on day 1, due to emaciation and diarrhoea. No clinical observations were noted in the survivors
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- PC induction concentration 10%; PC challenge concentration 10%
- No. with + reactions:
- 5
- Total no. in group:
- 6
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test item was found to be a skin sensitiser.
- Executive summary:
The study was performed using an Open Epicutaneous Test method under GLP. The method was consistent with Klecak G. et. al., (1977). Screening of fragrance materials for allergenicity in the guinea pig. J. Soc. Cosmet. Chem. 28: 53-64, test to assess the skin sensitisation potential of the test item. The concentrations selected for the main study were based on the results of a preliminary study. In the main study, induction was via daily topical application of the test item diluted with polyethylene glycol to 0% (control), 25%, 50%, 75%, and 100% for 5 days/week between days 1 -26. A treatment group of 6 per concentration and a control group of 6, respectively were on day 26, challenged with 5%, 10%, 15% or 25% test item in PEG 300 vehicle. Skin reactions were evaluated 24 to 72 hours after challenge treatment. No clinical signs were reported, with the exception of one animal in the 100%-induction group, which was euthanised on day 1 due to emaciation and diarrhoea. Bodyweight gain in the treated group was comparable to controls, and all survivors gained bodyweight during the study. The maximum score in control was zero. All test groups showed positive results in at least 2 animals. Under the conditions of this study, the test item is considered to be a contact skin sensitiser.
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