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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 231-885-3 | CAS number: 7775-00-0
- 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:
- 10 Jul 2000 to 26 Oct 2000
- 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:
- 2 000
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- - Principle of test: Repeated Insult (occlusive) Patch Test
- Short description of test conditions: During the induction phase patches were applied three times per week (e.g. Monday, Wednesday and Friday) for a total of nine applications. Approximately two weeks after the final induction patch application, challenge patches were applied to the virgin test sites adjacent to the original induction patch site.
- Scoring: the sites were scored for skin reactions at the clinic 24, 48 and 72 hours post application. - GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(p-cumenyl)propionaldehyde
- EC Number:
- 231-885-3
- EC Name:
- 3-(p-cumenyl)propionaldehyde
- Cas Number:
- 7775-00-0
- Molecular formula:
- C12H16O
- IUPAC Name:
- 3-(4-isopropylphenyl)propanal
- Test material form:
- liquid
1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 113
- Sex: male and female
- Age: 19 to 76
- Race: Not specified - Clinical history:
- - Healthy subjects were selected based on the absence of pre-existing skin disease which might be confused with a skin reaction from the the material or may be reasonable expected to affect the outcome of the study.
- Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to the study
- Subjects were excluded if under a doctors care or taking medication which could influence the outcome of the study. In addition, subjects with a history of adverse reactions to cosmetics or other personal care products were excluded. Females must be non-pregnant or nursing. - Controls:
- As a negative control distilled water in vehicle was applied
- 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: The test material was applied to the 3/4"x 3/4" (equivalent to 3.6 cm²) gauze portion of an adhesive dressing. These patches were allowed to air dry for 30 min, not exceeding 90 min before application.
- Vehicle / solvent: alcohol SD39C:DEP (75:25)
- Concentrations: 2% (w/w)
- Volume applied: 0.2 mL of each test material
- Testing/scoring schedule:
Induction phase: Patches were applied three times per week (e.g. Monday, Wednesday and Friday) for a total of nine applications. The evaluation of each site was made again just prior to re-application. If a participant was unable to report for an assigned test day, one makeup day was permitted. This day was added to the induction period. Rest periods consisted of 24 hours following each Tuesday and Thursday removal and 48 hours following each Saturday removal.
Challenge phase: Approximately two weeks after the final induction patch applications, challenge patches were applied to virgin test sites adjacent to the original induction patch sites, following the same procedure described for induction. The patches were removed and the sites were scored at the clinic 24, 48 and 72 hours pos-application.
- Removal of test substance: Following supervised removal and scoring of the first induction patches, participants were instructed to remove all subsequent induction patches at home, 24 hours after application. During the challenge phase, patches were removed and the sites scored at the clinic 24, 48 and 72 hours post-application.
- Other: The upper back between the scapulae served as treatment area.
EXAMINATIONS
The scoring system used:
0= No visible skin reaction
+= Barely perceptible or spotty erythema
1= Mild erythema covering most of the test site
2= Moderate erythema, possible presence of mild edema
3= Marked erythema, possible edema
Results and discussion
- Results of examinations:
- - At an application of 2% Cyclemax both treatment sites remained negative throughout the test interval.
- 99 subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test a test substance concentration of 2% test substance was not sensitising.
- Executive summary:
A HRIPT test was performed with 2% test substance in a vehicle of alcohol SD39C:DEP (75:25). 99 volunteers finished the study and were exposed to 0.2 mL solution under occlusive conditions. The subjects were instructed to remove the bandages 24 hours after application. Application sites were evaluated again just prior to re-application. During the induction phase, the subjects were administered 3 days a week (e.g. Monday, Wednesday and Friday) till 9 applications had been made. The test patch was applied to the same site each time. As a negative control, patches with distilled water in vehicle were applied. After approximately two weeks challenge patches were applied to a virgin test site, and removed after 24 hours. Reactions to the challenge were analyzed after 24, 72 and 96 hours. None of the 99 subjects showed reactions to the test material during the study. Therefore, under the conditions of the test 2% test, substance was concluded not to be sensitizing.
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.