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EC number: 248-742-6 | CAS number: 27939-60-2
- 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:
- 24-10-2001 to 30-11-2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- not a guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- - Principle of test: 9 Repeated Insult (occlusive) Patch Test (9-RIPT)
- Short description of test conditions: During the induction phase a sufficient amount of test article was placed to the back of each subject, every Monday, Wednesday and Friday till 9 applications had been made. The patch was removed after 24 hours. During the challenge phase (after a rest period of 2 weeks), the challenge patch was applied to a previously unpatched test site.
- Parameters analyzed / observed: During the induction phase positive reactions of a level 2 erythema or greater results in a change of application site. After the challenge, the site was scored after 24, 48 and 72 hours for erythema. All subjects were instructed to report any delayed skin reactivity. - GLP compliance:
- no
- Remarks:
- according to GCP regulations
Test material
- Reference substance name:
- Dimethylcyclohex-3-ene-1-carbaldehyde
- EC Number:
- 248-742-6
- EC Name:
- Dimethylcyclohex-3-ene-1-carbaldehyde
- Cas Number:
- 27939-60-2
- Molecular formula:
- C9H14O
- IUPAC Name:
- (1R,6R)-3,6-dimethylcyclohex-3-ene-1-carbaldehyde; (1R,6R)-4,6-dimethylcyclohex-3-ene-1-carbaldehyde
- Test material form:
- liquid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 110
- Sex: 18 (M)/ 92 (F)
- Age: 21-69
- Clinical history:
- The subjects did no exhibit any physical or dermatological condition that would have precluded application of the test article or determination of potential effects of the test article.
- Route of administration:
- dermal
- Details on study design:
- ADMINISTRATION
- Type of application: occlusive
- Description of patch: Park-Davis Readi-Bandage
- Vehicle / solvent: not specified
- Concentrations: 1% (v/v)
- Volume applied: 0.2 mL
- Testing schedule:
During the induction phase a sufficient amount of test article was placed to the back of each subject, every Monday, Wednesday and Friday till 9 applications had been made. 2 weeks after the final application a challenge patch was applied to a previously unpatched test site.
-Scoring schedule:
The site was scored 24, 48 and 72 hours after application. The subjects were instructed to report any delayed skin reactivity.
- Removal of test substance: The subjects removed the bandage 24 hours after application
EXAMINATIONS
- Grading/Scoring system: 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
RECHALLENGE
- One subject returned approximately 6 weeks after the study for a rechallenge with the substance under previously unpatched test sites under occlusive (back patch), semi-occlusive (back patch) and open (forearm) application. is not associated with an allergic dermatitis response.
Results and discussion
- Results of examinations:
- SYMPTOMS
- At 1% which was used in this study, no responses were noted on any subject during the induction phase. During the challenge phase 1 (1/106) mild (level 1) response was observed at the 48 hour evaluation. At the 72 hour evaluation the response decreased to a barely perceptible (+) and no response was noted at the 96 hour evaluation. Due to the transient nature, the responses were not considered to be evidence for sensitisation.
OTHER RESULTS:
- 4 subjects (4/110) discontinued for personal reasons unrelated to the conduct of the study
- One subject, who showed a mild and transient response, was re-challenged (approximately 6 weeks after the end of the study). The results indicated that the substance is not associated with an allergic dermatitis response.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test 1% test substance was not sensitising.
- Executive summary:
An HRIPT test was performed with 1% test substance. 106 volunteers finished the study and they were exposed to 0.2 mL solution mainly under occlusive conditions. The subjects removed the bandages 24 hours after application. The basic schedule was kept in the induction phase every Monday, Wednesday and Friday till 9 applications had been made. The test patch was applied to the same site each time, unless reaction to sample rendered this inadvisable, in which case the test patch was applied to a distant site. After two weeks a challenge patch was applied to a site not previously exposed and removed after 24 hours. Reactions to the challenge were assessed after 24, 72 and 96 hours. None of the 106 subjects tested was sensitized by the sample. In addition, for one subject who showed a mild and transient response, a re-challenge was performed 6 weeks after the study. From occlusive, semi-occlusive and open application it was concluded that under the conditions of the test 1% test substance is not sensitizing.
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