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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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 15-02-2006 to 12-04-2006
- 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:
- 2 006
- Report date:
- 2006
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- US FDA Regulation: CFR Title 21, Part 312, Investigational New Drug Application
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- US FDA Regulation: CFR Title 21, Part 50, Protection of Human Subjects
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- US FDA Regulation: CFR Title 21 Part 56, Institutional review Boards
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other:
- Version / remarks:
- The RFIM human repeated insult patch test protocol ; V.T. Politano & A.M. Api, Regulatory Toxicology and Pharmacology 52 (2008) 35–38
- Deviations:
- yes
- Remarks:
- Utilised an occlusive patch rather than semi-occlusive (typically used to enhance the sensitivity of the test method)
- GLP compliance:
- yes
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: Not reported. Presumed to be ambient conditions in original container.
- Other: clear liquid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 110 (a sufficient number to provide 100 completed subjects)
- Sex: 20 Male / 90 Female
- Age: 18 – 74 years old
- Race: Not reported.
- Demographic information: Not reported.
- Other: The subjects chosen were dependable and able read and understand instructions. The subjects did not exhibit any physical or dermatological condition that would precluded application test article or determination potential effects of the test item. - Clinical history:
- - History of allergy or casuistics for study subject or populations: None reported. Per: The RFIM human repeated insult patch test protocol ; V.T. Politano & A.M. Api, Regulatory Toxicology and Pharmacology 52 (2008) 35–38 wherein it indicates: “The subjects should not exhibit any physical or dermatological condition which would preclude application of the test articles. The subjects must fit all of the inclusion and exclusion criteria listed”.
- Symptoms, onset and progress of the disease: Not applicable.
- Exposure history: None.
- Aggravating factors both in home and workplace: Not applicable.
- Family history: Not reported ; however will be screened for and excluded per the aforementioned standard methodology.
- Medical history (for respiratory hypersensitivity): Not applicable.
- Any other allergic or airway disorders: however will be screened for and excluded per the aforementioned standard methodology.
- Smoking history: Not applicable.
- Other: See table 1: Inclusion and exclusion criteria within V.T. Politano & A.M. Api, Regulatory Toxicology and Pharmacology 52 (2008) 35–38 for further information on the utilised protocols of the HRIPT. - Controls:
- None
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: modified Parke-Davis Readi-Bandage occlusive patch
- Vehicle / solvent: non-per se ; the test item was reported as 15% [test item name] ; it can be presumed that the vehicle utilised (85%) will be a standard vehicle such as Ethanol or DEP or similar commonly utilised within the HRIPT test ; The preferred vehicle of the RIFM is 75% diethyl phthalate (DEP)/25% EtOH as referenced within: Politano & Api, Regulatory Toxicology and Pharmacology 52 (2008) 35–38
- Concentrations: Single ; 15%
- Volume applied: 0.2 mL
- Testing/scoring schedule: (1) Induction phase: 0.2 mL was placed onto the patch and applied to the upper arm. The subjects were instructed to remove the patch 24 hours after application. Twenty-four hour rest periods followed the Tuesday and Thursday removals and 48-hour rest periods followed each Saturday removal. Subjects returned to the Testing Facility and the site was scored by a trained examiner just prior to the next patch application. If a subject developed a positive reaction of a level 2 erythema or greater during the Induction phase or if, at the discretion of the Study Director, the skin response warranted a change in site, the patch was applied to a previously unpatched, adjacent site for the next application. If a level 2 reaction or greater occurred at the new site, no further applications were made. However, any reactive subjects were subsequently Challenge patch tested. (2) Challenge phase: After a rest phase of ca. 2 weeks (no applications) the challenge patch was applied to a previously unpatched (virgin) site. The site was scored at 24 and 72 hours after application. All subjects were instructed to report any delayed skin reactivity that occurred after the final challenge patch reading.
- Removal of test substance: None, see above
- Other: Not applicable.
EXAMINATIONS
- Grading/Scoring system: Dermal responses for both the Induction and Challenge phases of the study were scored according to the following 6-point scale:
0 = No evidence of any effect
+ = Barely perceptible (Minimal, faint, uniform or spotty erythema)
1 = Mild (Pink, uniform erythema covering most of the contact site)
2 = Moderate (Pink-red erythema uniform in the entire contact site)
3 = Marked (Bright red erythema with/without petechiae or papules)
4 = Severe (Deep red erythema with/without vesiculation or weeping)
All other observed dermal sequelae (e.g. edema, dryness, hypo- or hyperpigmentation) were appropriately recorded on the datasheet and described as mild, moderate or severe.
- Statistical analysis: None.
- Other: Not applicable.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: 97/110 indicated score = 0 ; 13 individuals did not complete the study due to personal reasons unrelated to the study conduct
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/97
- Number of subjects with negative reactions: 97/97
- Number of subjects with equivocal reactions: Not applicable
- Number of subjects with irritating reactions: Not applicable
RESULT OF CASE REPORT: Negative ; the test item was “dermatologist-tested” and did not induce skin irritation or show evidence of induced contact dermatitis in human subjects.
OTHER RESULTS: Thirteen (13/110) subjects discontinued for personal reasons unrelated to the conduct of the study. Discontinued panellist data are shown up to the point of discontinuation, but are not used in the conclusions section of the final report.
Any other information on results incl. tables
Table 1. summary of dermatologic response data for the main study is the provided in the following table:
Response |
Induction evaluation number |
Total |
Challenge Phase |
|||||||||
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
|
24h |
72h |
Negative |
97 |
97 |
97 |
97 |
97 |
97 |
97 |
97 |
97 |
97 |
97 |
97 |
Equivocal |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Positive |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
13 out of 110 panelist discontinued for reasons unrelated to the study (all score = 0 prior to discontinuing)
97 out of 97 panelists that concluded the study indicated a maximum score = 0 with no other observations noted
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, there was no evidence of sensitisation and of irritation to the test item (which consisted of the test substance at 15% concentration in vehicle).
- Executive summary:
The study was conducted as a human repeat insult patch test under occlusive dressing according to: US FDA Regulation: CFR Title 21, Parts 50, 56 and 312 under GLP conditions. The test article (consisting of the test substance at 15% concentration) was tested was to determine the irritation and/or sensitisation potential of the test article after repeated application under occlusive patch test conditions to the skin of human subjects (exclusive panel). A total of 110 volunteer subjects, 20 males and 90 females ranging in age from 18 to 74 years, were empanelled for the test. Applicant assessment indicates that the test protocol could be considered: equivalent or similar to the RFIM human repeated insult patch test protocol cited in: V.T. Politano & A.M. Api, Regulatory Toxicology and Pharmacology 52 (2008) 35–38. 0.2 mL of the test article was applied every Monday, Wednesday and Friday until 9 applications had been made with the use of occlusive dressing to increase test sensitivity applied to the upper arm in the induction phase. The subjects were instructed to remove the patch 24 hours after application. Twenty-four hour rest periods followed the Tuesday and Thursday removals and 48-hour rest periods followed each Saturday removal. Subjects returned to the Testing Facility and the site was scored by a trained examiner just prior to the next patch application.If a subject developed a positive reaction of a level 2 erythema or greater during the Induction phase or if, at the discretion of the Study Director, the skin response warranted a change in site, the patch was applied to a previously unpatched, adjacent site for the next application. If a level 2 reaction or greater occurred at the new site, no further applications were made. However, any reactive subjects were subsequently Challenge patch tested. In the challenge phase: after a rest phase of ca. 2 weeks (no applications) the challenge patch was applied to a previously unpatched (virgin) site. The site was scored at 24 and 72 hours after application. All subjects were instructed to report any delayed skin reactivity that occurred after the final challenge patch reading. 13 out of 110 panellist discontinued for reasons unrelated to the study (all score = 0 prior to discontinuing). 97 out of 97 panellists that concluded the study indicated a maximum score = 0 with no other observations noted. There was no skin reactivity observed at any time during the course of the study.Under the conditions of this study, there was no evidence of sensitisation and of irritation to the test item (which consisted of the test substance at 15% concentration in vehicle).
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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