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EC number: 247-568-8 | CAS number: 26266-57-9
- 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:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature (no data on test substance purity, limited documentation, tested product only contained 4% test substance)
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, Vol4, 3, 1985, p 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:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- 28-days dermal toxicty study, where 4 male and 4 female rabbits received an application of 0.3 and 0.9 mL/kg per 75 cm² body surface area, respectively, of a product containing 4% test substance.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 26266-57-9 [purity: 4%]
- IUPAC Name:
- 26266-57-9 [purity: 4%]
- Details on test material:
- - Analytical purity: no data, but the product was assumed to contain 4% of the test substance
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino
- Sex:
- male/female
Administration / exposure
- Details on exposure:
- TEST SITE
- Area of exposure: 75 cm² on the back
- Preparation of test site: shaved (all), abraded (2 animals)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 and 0.9 mL/kg per 75 cm² body surface area
- Concentration (if solution): 4% in technical product - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- daily, 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.3, 0.9 mL product/kg bw/day
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
0.012, 0.036 mL/kg bw/day
Basis:
other: based on the information that the product contains 4% of the test substance
- Remarks:
- Doses / Concentrations:
13, 39.24 mg/kg bw/day
Basis:
other: calculated on a density of 1.09 g/cm³ (see chapter 4.4)
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
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
URINALYSIS: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, animals were necropsied 2 days after the last application
- Organ weights of liver, kidney, heart, spleen, thyroid, adrenals, testes, ovaries were taken and body to organ weight ratios were performed
HISTOPATHOLOGY: Yes
- Examinations of liver, kidney, heart, spleen, thyroid, adrenals, testes, ovaries, thymus, urinary bladder, stomach, duodenum, jejenum, ileum, colon, straited muscles, treated skin
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- one control and one animal of the low-dose group became anorectic but recovered within a week; no deaths occured
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- edema and erythema developed in animals of both dose groups with more severe effects in the animals of the high dose group
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- one control and one animal of the low-dose group became anorectic but recovered within a week; no deaths occured
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No mortality was noted during the study. One control and one low-dose animal became anorectic but recovered within a week. Animals treated with 0.3 mL/kg bw developed mild to moderate skin erythema during the first 2 weeks of treatment. Mild to moderate edema and scaly desquamation developed during the second week. Two animals had severe erythema during the last week of treatment. Similar but more severe dermatitis developed in the high-dose group.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 39.24 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.