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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 13 April1987 to 1 May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test:
Comedogenicity Assay
- Short description of test conditions: After a 6 day adaptation period, 6 uniquely identified rabbits were treated with the test material as a 6% w/w
solution in cottonseed oil. The test material was applied to the internal base of the right ear of each animal daily on 5 consecutive days per week for 3 weeks. The left ear was treated with cottonseed oil only and served as the positive control. The test material was applied at approximately the same time each day in a manner to ensure complete coverage of the test site.
- Parameters analysed / observed: Prior to each application, the test site and the positive control ear were scored for hyperkeratosis and comedone formation according to the in vivo Comedone scoring scale. - GLP compliance:
- not specified
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farms, Belvidere, NJ
- Age at study initiation:
- Weight at study initiation:
- Housing: individually in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow ad-libitum.
- Water (e.g. ad libitum): Tap water supplied by automatic water system
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64-84°C.
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- other: Cottonseed oil
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 6% w/w solution in cottonseed oil - Duration of treatment / exposure:
- The test material was applied to the internal base of the right ear of each animal daily on 5 consecutive days per week for 3 weeks.
- Observation period:
- None, all animals were sacrificed after the last evaluation.
- Number of animals:
- Six rabbits (6 male, 0 female)
- Details on study design:
- TEST SITE
- Area of exposure: internal base of the right ear
- % coverage: N/A
- Type of wrap if used: None
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: N/A
OBSERVATION TIME POINTS
Prior to each application, the test site and the positive control ear were scored for hyperkeratosis and comedone formation.
SCORING SYSTEM:
- Method of calculation: Degree of Comedone Formation
Score Deqree of Comedone Formation
0 No increase in visible follicular hyperkeratosis
1 An increase in visible hyperkeratosis
2 An increase in visible hyperkeratosis extending to the possible presence of comedones
3 Significant comedones
4 Significant comedones
5 Severe lesions
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Comedone score
- Basis:
- mean
- Time point:
- other: 20 days
- Score:
- 0.4
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- other: Non-Comedogenic as a 6% w/w solution in cottonseed oil.
- Irritant / corrosive response data:
- SUMMARY OF DATA
IN-LIFE
Average Comedone Score: 0.4 test solution; 0.08 control.
Number of Comedones at termination: 0 test solution; 0 control.
HISTOLOGY:
Average Comedone Score: 0.9 test solution; 0.5 control.
Number of Comedones: 0 test solution; 0 control.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Comedogenicity Assay was conducted using the test substance as a 6% w/w solution in cottonseed oil. Based on the average in-life and histological scores, the test material, was considered to be non-comedogenic.
- Executive summary:
The Comedogenicity Assay was conducted using the test substance as a 6% w/w solution in cottonseed oil. The right ear of six young adult New Zealand White rabbits were treated with the test material and the left ear was dosed with cottonseed oil (positive control) on 5 consecutive days per week for 3 consecutive weeks. The ears were scored for hyperkeratosis and comedone formation each day prior to application of the test material. At termination, the control and treated ears were excised and subsequently subjected to histological examination for comedones.
All rabbits appeared active and healthy throughout the test period. All gained weight. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. Transient, mild hyperkeratosis (scores 1-2) was noted during the second and third weeks of dosing. The average "in-life" scores for the test and control ears were 0.19 and 0.16, respectively. The total number of visible comedones at test termination was zero for treated and control ears. Histological examination showed that all ears (treated and control) were negative with respect to comedone formation although hyperkeratosis with scores of 1-2 was noted in all but one treated section and in 6 out of 12 control sections. The average group histology scores for treated and control ears were 1.1 and 0.5, respectively. The total number of comedones identified histologically was zero for both treated and control ears. Based on the average in-life and histological scores, the test material, applied as a 6% w/w solution in cottonseed oil, is considered to be non-comedogenic.
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