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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 28 February 1977 to 8 April 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
- Remarks:
- Skin irritation and Skin sensitization study results in one study report.
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 0.1 ml. of the test sample instilled into the right eye with no further treatment. as its own control. The untreated left eye of each animal served Both the treated and control eyes were examined every twenty-four hours for four days and then again on the seventh day. The scorings recorded were made according to the Draize scale for scoring ocular lesions.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No information reported.
- Vehicle:
- other: Mineral oil
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 20 % - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Draize scale for scoring ocular lesions.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation observed.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test substance in 20% mineral oil did not produce irritating effects.
- Executive summary:
Three normal, healthy, albino rabbits were used in this experiment. The method of procedure is that suggested by Dr. Draize.
Each animal had 0.1 ml. of the test sample instilled into the right eye with no further treatment as its own control. The untreated left eye of each animal served Both the treated and control eyes were examined every twenty-four hours for four days and then again on the seventh day. The scorings recorded were made according to the Draize scale for scoring ocular lesions. Exposure to the test substance did not produce any irritation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Induction phase: The patch was occlusive and remained in situ for twenty-four hours.
Skin Scoring scale:
0 - No visible erythema.
1 - Erythema.
2 - Erythema plus swelling.
3 - Erythema, swelling, plus papules.
4 - Severe irritation consisting of erythema, swelling, papules, and necrosis and extension beyond the boundaries of contact.
If the reaction was not substantial, i.e., not in excess of a grade of 1, the test material was reapplied to the same site for twenty-four hours. This procedure was repeated on Wednesday and Thursday for a total of four consecutive exposures each week for three weeks. After the fourth patch was removed and read each Friday, the patch sites were rested on Saturday and Sunday. If any patch site developed a reaction of 2 or greater, the investigator could, at his discretion, continue subsequent applications on that same site or on a new site, and continue the same type of patch (occlusion) or change to semioccluded or open applications. In all, a total of twelve applications and readings were scheduled for the induction period.
Challenge Phase: On the 36th day of the study, after a rest period of slightly more than two weeks, the test material was applied on a new site as a challenge. At the end of twenty-four hours, the occluded patch was removed and the site was read for the immediate response. Followup readings were made twenty-four, forty-eight, and seventy-two hours later. - GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Historical skin sensitisation data already available to fulfill endpoint requirement.
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
In vivo test system
Test animals
- Species:
- other: Human volunteers
- Strain:
- other: Human volunteers
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 20%, 40%, 60%, 80%, and 100% concentration with a density of application of approximately 0.1 rnL of the test material per square centimeter.
- Day(s)/duration:
- 24
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Applied on day 36 to a virgin site
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 53
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- N/A
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: Application No. 1
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 - 100% concentration
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- The test material, at concentrations ranging from 20% to 100%, did not elicit any visible evidence of irritation in any of the individuals under test.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Application Nos. 2 - 4
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 - 100% concentration
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- The test material, tested at 100%, did not elicit any visible evidence of irritation in any of the individuals under test.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Application Nos. 5 - 12
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% concentration
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- The test material, at conc. ranging from 20% to 100%, did not elicit any visible evidence of irritation in any of the individuals. On the basis of these results, it was decided that all subsequent applications were at 100% concentrations.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Application No. 13, Challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% concentration
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- The test material, tested at 100%, did not elicit any visible evidence of irritation in any of the individuals under test.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No visible skin damage was observed in any of the individuals participating in this test. This evidence of apparent innocuousness enables the investigator to express an opinion that there is nothing in the results which could be construed to be a contraindication to the use of this material in a general human population.
- Executive summary:
53 human volunteers were used in the skin sensitization study with the test material applied occlusively between 20 - 100% concentration. No visible skin damage was observed in any of the individuals participating in this test. This evidence of apparent innocuousness enables the investigator to express an opinion that there is nothing in the results which could be construed to be a contraindication to the use of this material in a general human population.
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