Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 247-569-3 | CAS number: 26266-58-0
Toxicological information
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.
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.
