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EC number: 270-315-8 | CAS number: 68424-66-8
- 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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Remarks:
- Skin irritation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 28 February 1977 to 8 April 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- 53 human volunteers were used to test the irritation potential of the test material under conditions of a stringently supervised and monitored patch test. The test material was tested in concentrations of 20%, 40%, 60%, 80%, and 100%.
- GLP compliance:
- no
- Remarks:
- Not applicable
Test material
- Reference substance name:
- Lanolin, hydroxylated
- EC Number:
- 270-315-8
- EC Name:
- Lanolin, hydroxylated
- Cas Number:
- 68424-66-8
- IUPAC Name:
- Lanolin, hydroxylated
- Test material form:
- solid
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed:
- Age: 18 or over
- Known diseases: Absence of skin disease. General well-being. - Ethical approval:
- confirmed, but no further information available
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- 20%, 40%, 60%, 80%, and 100% concentration with a density of application of approximately 0.1 rnL/cm²
Group I - 11 Subjects - 60% in petrolatum.
Group II - 11 Subjects - 20% in petrolatum.
Group III - 11 Subjects - 100% as supplied.
Group IV - 11 Subjects - 80% in petrolatum.
Group V - 11 Subjects - 40% in petrolatum.
(2 subjects dropped out prior to the initiation of the study in groups III and V, leaving a total of 53 subjects during the remainder of the study). - Examinations:
- Evalutated after 24 hours to determine skin irritation.
Reactions were evaluated according to the following scale:
0 = No visible erythema
1 = Erythema
2 = Erythema plus swilling
3 = Erythema, swelling, plus papules
4= Severe irritation consisting of erythema, swelling, papules and necrosis and extension beyond the areas of contact.
Results and discussion
- Results of examinations:
- The test material at concentrations ranging from 20 % to 100 %, did not elicit any visible evidence of irritatyion in any of the individuals under the test.
Applicant's summary and conclusion
- Conclusions:
- The test material was tested in concentrations of 20%, 40%, 60%, 80%, and 100%, which produced no visible damage to the skin of any of the 53 individuals who completed the test. The test material was concluded to be incapable of acting as a primary skin irritant under the conditions of the test.
- Executive summary:
53 human volunteers were used to test the irritation potential of the test material under conditions of a stringently supervised and monitored patch test. The test material was tested in concentrations of 20%, 40%, 60%, 80%, and 100%, which produced no visible damage to the skin of any of the 53 individuals who completed the test. These observations would indicate that the use of this substance, even in the higher concentrations, should pose no significant hazard.
The test material was concluded to be incapable of acting as a primary skin irritant under the conditions of the test.
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