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EC number: 432-500-3 | CAS number: -
- 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:
- key study
- Study period:
- January 27 to March 12, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated Insult Patch test according to an internal protocol as outlined in the Fedral Register vol. 46, no. 17, 1981.
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- not specified
- Details on test material:
- No data
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: initially 114, 107 completed the study
- Sex: male and female
- Age: 6 to 79 years
- Race: not indicated - Clinical history:
- - History of allergy or casuistics for study subject or populations: excluded
- Symptoms, onset and progress of the disease: absence of any visible skin desease
- Exposure history: no use of topical or systemic steroids or antihystamines seven days prior to the start of the test
- Aggravating factors both in home and workplace: None defined
- Family history: Not defined
- Medical history (for respiratory hypersensitivity): Not relevant
- Any other allergic or airway disorders: If present, not included - 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: 3/4"x 3/4"absorbent pad portion of an adhesive dressing
- Concentrations: 100%
- Volume applied: 0.2 g
- Dermal dosage: 55 mg/cm2
- Induction period: Patches applied three times a week for a total of nine applications
- Challenge phase: Approx. 2 weeks after the final Induction patch application, a challenge patch was applied to a virgin test siteadjecent to the original patch site and after removal scored for reaction after 24 and 72 h.
EXAMINATIONS
- Grading/Scoring system:
0= No visible skin reaction
+= Barely perceptible or spotty erythema
1= Mild erythema
2= Moderate erythema + possible mild edema
3= Marked erythema + possible edema
4= Severe erythema, possible edema, vesiculation, bullae and/or ulceration
Results and discussion
- Results of examinations:
- RESULT OF CASE REPORT: Observations remained completely negative for all participants throughout the test interval.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, Ceraphyl MTE did not indicate a potential for dermal irritation or allergic contact sensitization at a dermal dose of 55 mg/cm2.
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