Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 941-893-5 | CAS number: 15229-79-5
- 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:
- 17-01-2018 to 23-02-2018
- 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:
- 2 018
- Report date:
- 2018
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 50, Protection of Human Subjects
- Deviations:
- no
- Qualifier:
- equivalent or similar 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:
- US FDA Regulation: CFR Title 21, Part 312, Investigational New Drug Application
- 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:
- no
- Remarks:
- Testing was conducted under laboratory/clinical Quality Assurance procedures (raw data retailed at the named laboratory/clinic)
Test material
- Reference substance name:
- (3E,7E)-cyclododeca-3,7-dien-1-one; (4E,8Z)-cyclododeca-4,8-dien-1-one; (4Z,8E)-cyclododeca-4,8-dien-1-one
- EC Number:
- 941-893-5
- Cas Number:
- 15229-79-5
- Molecular formula:
- C12H18O
- IUPAC Name:
- (3E,7E)-cyclododeca-3,7-dien-1-one; (4E,8Z)-cyclododeca-4,8-dien-1-one; (4Z,8E)-cyclododeca-4,8-dien-1-one
- 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: pale yellow
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 117 (a sufficient number to provide 100 completed subjects ; 1 discontinued due to protocol deviation and 8 discontinued for personal reasons; no subjects discontinued due to test material / test item reaction)
- Sex: 41 Male / 67 Female (n = 108 total) completed the study ; 3 males and 6 females (n = 8) discontinued the study
- Age: 20 – 69 years old
- Race: Not reported.
- Demographic information: Not reported.
- Other: The subjects chosen were dependable and able to read and understand instructions. The subjects did not exhibit any physical or dermatological or medical 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”. The laboratory/clinic reported SOPs and protocols match the above (documented in the full study report).
- 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: webril/adhesive patch occlusive patch
- Vehicle / solvent: non-per se ; the test item was reported as 2.4% [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 ; 2.4%
- Volume applied: 0.3 mL
- Testing/scoring schedule: (1) Induction phase: 0.3 mL was placed onto the patch and applied to the left side of the back with the test site indelibly marked and the test site recorded on the subjects individual data form. Each subject was instructed that the patch was to remain in place and kept dry for approximately 24 hours, at which time the patch was to be removed by the subject. An approximately 24-hour period, during which no test material was applied, followed the weekday patch removals; an approximately 48-hour period followed the weekend patch removals. A series of nine (9) Induction patchings were completed over a period of approximately three weeks. (2) Challenge phase: After a rest phase of ca. 2 weeks (no applications) the challenge patch was applied to a previously unpatched (virgin) site typically the opposite side of the back. The site was scored at 24 , 48, 72 and 96 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 scale, with additional footnotes as applicable :
0 = No visible reaction
± = Faint, minimal erythema
1 = Erythema
2 = Intense erythema, induration
3 = Intense erythema, induration, vesicles
4 = Severe reaction with erythema, induration, vesicles, pustules (may be weeping)
E = Edema
- = No reading
N9R = No 9th reading
All other observed dermal reactions/events (e.g. edema, dryness, hypo- or hyperpigmentation) would be when applicable, be appropriately recorded on the datasheet and described.
- Statistical analysis: None.
- Other: Not applicable.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: 107/108 indicated score = 0 ; 1/108 indicated score ± (Faint, minimal erythema) during the 9th induction only, this was not considered an adverse effect/event ; 9 individuals did not complete the study due to protocol deviation or due personal reasons unrelated to the study conduct
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/108
- Number of subjects with negative reactions: 108/108
- 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 reaction considered to be skin irritation or show evidence of induced contact dermatitis in human subjects. No adverse reactions or adverse events were reported in any of the subjects
OTHER RESULTS: Nine (9/117) subjects discontinued due to protocol deviation or due personal reasons unrelated to the study conduct. 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 |
Challenge Phase |
|||||||||||
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
24h |
48h |
72h |
96h |
0 |
115 |
114 |
114 |
112 |
112 |
111 |
111 |
110 |
108 |
108 |
108 |
108 |
108 |
± |
|
|
|
|
|
|
|
|
1 |
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
1E |
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
2E |
|
|
|
|
|
|
|
|
|
|
|
|
|
3E |
|
|
|
|
|
|
|
|
|
|
|
|
|
4E |
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
N9R |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9 out of 117 subjects discontinued for reasons unrelated to the study (all score = 0 prior to discontinuing)
108 out of 108 subjects that concluded the study indicated a maximum score = 0 during challenge with only one (1) other observations noted Faint, minimal erythema during induction reading 9 in one subject.
Note: subject 44 Male with the induction reading 9: ± (Faint, minimal erythema) continued into challenge phase and presented 0 scores at all challenge time points
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, there was no evidence of sensitisation and/of significant irritation to the test item (which consisted of the test substance at 2.4% concentration in vehicle).
- Executive summary:
The study was conducted as a human repeat insult patch test under occlusive dressing according or equivalent or similar to to: US FDA Regulation: CFR Title 21, Parts 50, 56 and 312. 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. The test article (consisting of the test substance at 2.4% 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 117 volunteer subjects, 44 males and 73 females ranging in age from 20 to 69 years, were empanelled for the test which were a sufficient number to provide 100 completed subjects ; 1 discontinued due to a protocol deviation and 8 discontinued for personal reasons; no subjects discontinued due to test material / test item reaction. The induction phase consisted of placing 0.3 mL test item onto the occlusive patch and applied to the left side of the back with the test site indelibly marked and the test site recorded on the subjects individual data form. Each subject was instructed that the patch was to remain in place and kept dry for approximately 24 hours, at which time the patch was to be removed by the subject. An approximately 24-hour period, during which no test material was applied, followed the weekday patch removals; an approximately 48-hour period followed the weekend patch removals. A series of nine (9) Induction patchings were completed over a period of approximately three weeks. The challenge phase was conducted after a rest phase of ca. 2 weeks (no applications) whereby, the challenge patch was applied to a previously unpatched (virgin) site typically the opposite side of the back. The site was scored at 24 , 48, 72 and 96 hours after application. 108 out of 108 subjects that concluded the study indicated a maximum score zero (0) during challenge with only one other observation noted: faint, minimal erythema during induction reading 9 in one subject. No adverse reactions or adverse events were reported in any of the subjects. 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 2.4% 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.