Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: - | 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- march 25 - April 3rd, 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No analytical certificate, no inclusion of phototype I skin, no explanation on final grading method for skin compatibility (in the conclusion)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
- Type of study / information:
- Patch test in human volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Draize JH, Appraisal of the safety of chemicals in food, drugs and cosmetics. FDA (ed), USA, 1959, pp 46-48
Frosch PJ & Kligman AM, The Duhring Chamber: an improved technique for epicutaneous testing of irritant and allergic reactions, Contact Dermatitis, 1979, 5, pp 73-81
Matthies W, Test startegies for development of cosmetic products using dermatological test models, Seifen-Öle-Fette-Wachse, 1991, 117, pp 42-43
Mikulowska A, Reactive changes in human epidermius following simple occlusion with water, Contact dermatitis, 1992, 26, pp 224-227 - GLP compliance:
- no
- Remarks:
- GLP: not applicable / GCP: no certificate of analysis of test item: purity and stability unknown
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): CAE
- Physical state: brown-orange semi-liquid, oily
- Purity test date: not indicated
- Lot/batch No.: 1456
- Expiration date of the lot/batch: not indicated
- Stability under test conditions: not indicated
- Storage condition of test material: not indicated
Method
- Ethical approval:
- not specified
- Details on study design:
- Monocentric study in open, in 20 volunteers (final number after 2 exclusions). Inclusion and exclusion criteria were defined. Subject used as its own control.
- Exposure assessment:
- measured
- Details on exposure:
- EXPOSURE:
- Patch test on the back
- 160 µL of test item/person (exposure measured using micropipette)
- Negative control site: patch with distilled water
- skin contact for 48h
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:
- Skin phototypes II to IV included
- 17 women, 3 men
Results and discussion
- Results:
- Very slight erythema in 1/20 volunteer, Slight erythema in 1/20 volunteer : 10% of volunteers are reactive
Mdis = 0.075
The interpretation method enables to grade as "very good / good / quite good / moderate / bad skin compatibility", but the thresholds values (Mdis) for these classes are not indicated.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions adopted, the test item has a good skin compatibility.
- Executive summary:
Identical to "Results". NB: the substance being an intermediate in strictly controlled conditions, it is not used as a cosmetic raw material
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