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EC number: 218-002-7 | CAS number: 2035-93-0
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Human repeat insult patch test performed under Good Clinical Practice (GCP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Standard clinical methodology
- GLP compliance:
- yes
- Remarks:
- Conducted to GCP
Test material
- Reference substance name:
- 4-methyl-4-phenylpentan-2-ol
- EC Number:
- 218-002-7
- EC Name:
- 4-methyl-4-phenylpentan-2-ol
- Cas Number:
- 2035-93-0
- Molecular formula:
- C12H18O
- IUPAC Name:
- 4-methyl-4-phenylpentan-2-ol
- Test material form:
- other: Skin patch
- Details on test material:
- - Chemical name: 4-Methyl-4-phenylpentan-2-ol
- CAS number: 2035-93-0
- EC number: 218-002-7
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: Fifty-six (56)
- Sex: Male and female
- Age: 21-79 years of age
- Race: Not reported
- Demographic information: Not reported - Clinical history:
- Inclusion criteria:
1. Male and female subjects age 16 and over
2. Absence of any visible skin disease which might be confused with a skin reaction from the test material
3. Prohbition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation
4. Completion of a Medical History form and the understanding and signing of an Informed Consent form
5. Considered reliable and capable of following directions
Exclusion criteria:
1. Ill health
2. Under adoctor's care or taking medication(s) which could influence the outcome of the study
3. Females who were pregnant or nursing
4. A history of adverse reactions to cosmetics or other personal care products - Controls:
- There were no specific control individuals
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test) ; prick test; RAST; other immunological tests: Patch test
ADMINISTRATION
- Type of application: occlusive / semiocclusive /other: Occlusive
- Description of patch: 3/4" x 3/4" absorbent pad of an adhesive dressing manufactured by TruMed Technologies, Inc., Burnsville, MN, USA
- Vehicle / solvent: Not reported
- Concentrations: Not reported
- Volume applied: 0.2 mL of test material
- Testing/scoring schedule: The skin was assessed at each removal/replacement of the patch
- Removal of test substance: No washing of the skin following patch emoval was required
EXAMINATIONS
- Grading/Scoring system: 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; 4=Severe erythema, possible edema, vesiculation, bullae and/or ulceration
- Statistical analysis: Not performed
Results and discussion
- Results of examinations:
- All observations remained negative throughout the test interval.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material, Skin Lotion (AM1-0024), did not indicate a potential for dermal irritation or allergic contact sensitisation.
- Executive summary:
The objective of this study was to determine by repetitive epidermal contact, the potential of AM1-0024 to induce primary or cumulative irritation and/or allergic contact sensitisation in a group of 56 subjects comprising males and females between the ages of 21 and 79 years. Following an induction phase consisting of 9 patches, each containing 0.2 mL AM1-0024 being applied to the same area of skin in the interscapular region, a similar challenge patch was applied, 24 hours following the final induction patch, to a new area of skin. The examination of the skin sites following removal of each patch after 24 hours in situ revealed no changes to the skin suggestive of an irritant response or allergic contact sensitisation.
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