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Diss Factsheets
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EC number: 255-485-3 | CAS number: 41669-30-1
- 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: Acceptable, well documented study report which meets basic scienific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- The test substance was applied to the skin of 25 healthy human volunteers of both sexes under occlusive patches. For induction, the patches remained on the skin for 48 h or for the first 2 weekends for 72 h, and the challenge patches were removed after 48 h. Macroscopic examination of the application sites were then conducted about 24 and 48 hours after challenge patch removal.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isooctadecyl isooctadecanoate
- EC Number:
- 255-485-3
- EC Name:
- Isooctadecyl isooctadecanoate
- Cas Number:
- 41669-30-1
- Molecular formula:
- C36H72O2
- IUPAC Name:
- 2-methylheptadecyl 3-methylheptadecanoate
- Details on test material:
- - Name of test material (as cited in study report): Isostearate Isostearyle
- Physical state: very light yellow liquid
- Analytical purity: no data
- Lot/batch No.: 13782
- Storage condition of test material: protected from heat (between + 5°C and + 25°C and light
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 25
- Sex: 20 women, 5 men
- Age: 20 - 56 - Controls:
- not required, untreated sites of the same volunteer served as control
- 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: Finn Chambers on Scanpor, it is composed of an aluminium 8 mm in diameter covering a contact surface of 50 mm2. Each capsule was individually mounted onto an adhesive tape and was applied in such a manner to exert equal equal pressure on all capsules.
- Vehicle / solvent: Kernel stone oil
- Concentrations: 30%
- Volume applied: 0.02 mL
- Testing/scoring schedule: 9 application allocated on 3 weeks as follows:
1st week: day 1 (Monday: 1st application), day 3 (Wednesday), day 5 (Friday),
2nd week: day 8 (Monday), day 10 (Wednesday), day 12 (Friday)
3rd week: day 15 (Monday), day 17 (Wednesday), day (Friday)
EXAMINATIONS
- Grading/Scoring system: no visible cutaneous reaction - 0, very slight and hardly visible erythema - 1, erythema with small infiltration and sometimes papulae (no vesicles, no bullae), erythema with infiltration, papulae, vesicles -3, and severe erythema with infiltration, coalescent vesicles leading to bullae -4.
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions:
Induction + Challenge : none
- Number of subjects with negative reactions:
Induction + Challenge : 24. One volunteer abandonned during the induction phase therefore only results from 24 are available
- Number of subjects with irritating reactions: none
Applicant's summary and conclusion
- Conclusions:
- CLP: not classified
DSD: not classified
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