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Diss Factsheets
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EC number: 264-119-1 | CAS number: 63393-93-1
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
- Reference Type:
- secondary source
- Title:
- Fianl report of the safety assessment for Isopropyl Lanolate.
- Author:
- CIR
- Year:
- 1 980
- Bibliographic source:
- Journal of environmental pathology, toxicology and oncology;4/4, 121-132, 1980
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Maximization Test (Klingmann; Journal of Investigative Dermatology; No.5; 393-409; 1966): Occlusive skin exposure on the volar forearm or the back of all volunteers for five alternate-day 48-hour periods. Site was pretreated for 24 h with 2.5 % sodium lauryl sulfate under occlusion. Following a ten day rest period a challenge patch of the test material was applied to a different site for 48 hours. Prior to challenge SLS was again applied to test site for an hour. Observations were made after removal of the challenge patch and 24 hours thereafter.
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, lanolin, iso-Pr esters
- EC Number:
- 264-119-1
- EC Name:
- Fatty acids, lanolin, iso-Pr esters
- Cas Number:
- 63393-93-1
- Molecular formula:
- UVCB
- IUPAC Name:
- Fatty acids, lanolin, isopropyl esters
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Composition of test material, percentage of components: Two percent isopropyl lanolate in a soft, non-pourable cream with a low pH in a non-ionic oil-in-water emulsion
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 25
- Sex: 4 males, 21 females
- Age: 19 - 43
- Race: 3 black females, rest is given as white - Controls:
- none
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Testing/scoring schedule: five alternate day, 48-hour periods with patch on the volar forearm or the back; patch site pretreated with 2.5% SLS (24 hours), after ten days rest different site was pretreated with 5-10 % SLS for an hour and then patch test with test substance was applied for 48 hours; scores were determined immediately after removal of patch and 24 hours thereafter
- Other: a pre-test was done to determine use of SLS; 48 hour occlusive patch test on volar forearm or the back with test substance
EXAMINATIONS
- Grading/Scoring system: see Table1 under Any other information on materials and methods including tables
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms observed at both reading time points
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with negative reactions: 25
Applicant's summary and conclusion
- Conclusions:
- not sensitizing to human skin at 2%
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