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Diss Factsheets
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EC number: 261-819-9 | CAS number: 59587-44-9
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Insufficient for assessment (only a 5% formulation tested, test substance purity not specified, limited documentation, no ophthalmoscopic and neurobehavioural examination).
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
- Reference Type:
- secondary source
- Title:
- Final 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
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- only a 5% formulation tested, test substance purity not specified, limited documentation, no ophthalmoscopic and neurobehavioural examination
- GLP compliance:
- no
- Limit test:
- yes
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
- IUPAC Name:
- 63393-93-1
- Details on test material:
- - Name of test material (as cited in study report): isopropyl lanolate
- Physical state: yellow buttery solid
- Analytical purity: no data
- Composition of test material, percentage of components: 5% isopropyl lanolate and 3% glycol stearate in a liquid foundation
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: COBS CD (BR)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, In., Wilmington, Massachusetts
- Housing: Animals were individually housed in wire-mesh, stainless steel cages
- Diet: Teklad Mouse and Rat Died, ad libitum
- Water: tap water, ad libitum
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: 5% isopropyl lanolate and 3% glycol stearate in a liquid foundation
- Details on exposure:
- TEST SITE
- Time intervals for shavings or clipplings: Each rat was clipped weekly to remove dorsal hair. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks (animals received 65 applications in total)
- Frequency of treatment:
- once daily, 5 days a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 mg/kg bw
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 15
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily
BODY WEIGHT: Yes
- Time schedule for examinations: initially and weekly thereafter and on the day of necropsy
HAEMATOLOGY: Yes
- Time schedule for collection of blood: One week prior to the termination of the study, animals were fasted over night (16 hours).
- Anaesthetic used for blood collection: Yes
- Animals fasted: Yes
- How many animals: 15 animals
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: One week prior to the termination of the study, animals were fasted over night (16 hours).
- Animals fasted: Yes
- How many animals: 15 animals - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, at the end of the test, all animals were dissected, with a macroscopic assessment of the internal organs, these being weighed and preserved for histological investigations. The following organs were analyzed: thymus, trachea, esophagus, stomach, pancreas, small intestine, large intestine, ovary and bladder.
ORGAN WEIGHTS: Yes, brain, lung, heart, liver, spleen, kidney, adrenals and uterus
HISTOPATHOLOGY: Yes, tissues were subjected to histopathologic examination by A.A. Stein, M.D., Microscopy for Biological Research, Ltd., Albany, New York. The following organs were analyzed: bone marrow, liver, spleen, kidney, skin, brain, heart, lung and uterus.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- non adverse
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- non adverse
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- non adverse
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
All animals survived for the duration of the study.
External appearance of the skin at sites of application of the test substance was not different from that of control. All groups exhibited slight to moderate erythema and drying intermittently throughout the study.
During the period of application and at the end of the test, all animals were free from other symptoms.
BODY WEIGHT AND WEIGHT GAIN
The dose group exhibited higher body weights compared to the control group. After 14 days no significant differences were observed. Therefore, this finding was not believed to be compound-related.
HAEMATOLOGY
No deviations in comparison with the control animals.
CLINICAL CHEMISTRY
No deviations in comparison with the control animals.
ORGAN WEIGHTS
The kidney weight for the dose group was higher compared to the control value. The histopathology showed no deviations in comparison with the control anaimals. Therefore, this observation was not believed to be compound-related. All other organ weights were within the normal range.
GROSS PATHOLOGY
No deviations in comparison with the control animals.
HISTOPATHOLOGY: NON-NEOPLASTIC
No deviations in comparison with the control animals.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 100 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- other: clinical observations, body weight gains, hematology, clinical chemistry, organ weights, histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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