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EC number: 247-569-3 | CAS number: 26266-58-0
- 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:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Unsuitable test system (test substance can not be specifically incriminated, because a product containing 5% test substance was evaluated, limited documentation).
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Final Report on the Safety Assessment of Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Triolate
- Author:
- Elder, R.L., ed.
- Year:
- 1 985
- Bibliographic source:
- Journal of the American College of Toxicology 4(3): 65-121
- Reference Type:
- secondary source
- Title:
- Final Report on the Safety Assessment of Sorbitan Caprylate, Sorbitan Cocoate, Sorbitan Diisostearate, Sorbitan Dioleate, Sorbitan Distearate, Sorbitan Isostearate, Sorbitan Olivate, Sorbitan Sesquiisostearate, Sorbitan Sesquistearate, and Sorbitan Tri...
- Author:
- Lanigan RS, Yamarik TA; Cosmetic Ingredient Review Expert Panel
- Year:
- 2 002
- Bibliographic source:
- International Journal of Toxicology 21(suppl. 1): 93-112
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
- Principles of method if other than guideline:
- 93-days dermal toxicty study, where 5 male and 5 female rabbits received an application of 0.36 mL/260 cm² per 3 kg rabbit of a product containing 5% test substance.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 26266-58-0 [purity: 5%]
- IUPAC Name:
- 26266-58-0 [purity: 5%]
- Details on test material:
- - Analytical purity: no data, but the product was assumed to contain 5% of the test substance
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Details on exposure:
- TEST SITE
- Area of exposure: 260 cm² on the back
- Preparation of test site: clipped
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.36 mL/3 kg rabbit
- Concentration (if solution): 5% in technical product - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 93 days
- Frequency of treatment:
- daily, 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.36 mL product/3 kg rabbit/day
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
0.018 mL/3 kg rabbit/day
Basis:
other: based on the information that the product contains 5% of the test substance
- Remarks:
- Doses / Concentrations:
6.54 mg/kg bw/day
Basis:
other: based on a density of 1.09 g/cm³
- No. of animals per sex per dose:
- 5
- Control animals:
- other: yes, water
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule for examinations: daily
DERMAL IRRITATION (if dermal study): Yes
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: before start of the study, after 48 treatments, and at termination
- Parameters checked: hematocrit, hemoglobin, erythrocyte, total and differential leukocyte counts
URINALYSIS: Yes
- Time schedule for collection of blood: before start of the study, after 48 treatments, and at termination
- Parameters checked: pH and specific gravity of urine, urinary glucose, protein, and occult blood - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, on study day 94
- Abdominal and thoracic viscera, kidneys, liver, spleen, thyroid, heart, adrenals, gonads, skin from application site, cecum, thymus, pancreas, salivary glands, lymph nodes, lungs, urinary bladder, gallbladder, stomach, duodenum, jejunum, ileum, colon, and straited muscle
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- one treated female animal (not further specified) became moribund and was killed on day 57
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- slight erythema and desquamation was observed in all treated animals
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- one treated female animal (not further specified) became moribund and was killed on day 57
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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:
- not examined
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
One treated female animal (not further specified) became moribund and was killed on day 57. At necropsy, the animal showed empyema.
In treated animals, very slight erythema developed after 1 week of treatment; irritation intensified to slight erythema with occasional slight edema. After 4 to 6 weeks of treatment, scaly desquamation occured and persisted through the end of the study. The skin of water-treated animals was normal.
BODY WEIGHT
No substance-related effects noted.
FOOD CONSUMPTION
No substance-related effects noted.
HAEMATOLOGY
No substance-related effects noted.
URINALYSIS
No substance-related effects noted.
ORGAN WEIGHTS
No substance-related effects noted.
GROSS PATHOLOGY
No substance-related effects noted.
HISTOPATHOLOGY
No substance-related effects noted.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 6.54 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No systemic effects were noted.
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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