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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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EC number: 701-203-3 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Original report not available and documentation insufficient for assessment (analytical purity of test substance not specified, repeated treatment, 0.3 g application amount/treatment, scoring system not traceable).
Data source
Reference
- Reference Type:
- publication
- Title:
- Dermatitic Effect of Nonionic Surfactants I Gross, Microscopic, and Metabolic Changes in Rabbit Skin Treated with Nonionoc Surface-active Agents
- Author:
- Mezei, M. et al.
- Year:
- 1 966
- Bibliographic source:
- J Pharm Sci 55(6): 548-590
Materials and methods
- Principles of method if other than guideline:
- The test substance was applied daily to the clipped trunks of New Zealand White rabbits for a total of 81 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sorbitan monooleate, ethoxylated
- EC Number:
- 500-019-9
- EC Name:
- Sorbitan monooleate, ethoxylated
- Cas Number:
- 9005-65-6
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Sorbitan, C18-unsat, fatty acid esters, ethoxylated (1 - 6.5 moles ethoxylated)
- Reference substance name:
- Tween 80
- IUPAC Name:
- Tween 80
- Details on test material:
- - Name of test material (as cited in study report): polyoxyethylene (20) sorbitan monooleate (Polysorbate 80)
- Analytical purity: no data
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- open
- Preparation of test site:
- clipped
- Vehicle:
- other: water, hydrophilic ointment U.S.P. (H.O.)
- Controls:
- other: not required, untreated site and site treated with ointment base of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 g
- Concentration (if solution): 100% (undiluted), 10% in water, 10% in H.O., 5% in water and 5% in H.O.
VEHICLE
- Amount(s) applied: not specified - Duration of treatment / exposure:
- daily application without washing for a total of 81 days
- Observation period:
- up to 81 days
Reading time points: 3 and 10 days, 1 month - Number of animals:
- 50
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the whole experiment (on the 81st day)
Results and discussion
In vivo
- Irritant / corrosive response data:
- After 3 days, slight erythema and edema were observed in all treatment groups, except for treatment with 5% of the test substance in water which resulted in no visible change on the skin. After 10 days, moderate erythema and edema were observed after treatment with the undiluted test substance and the test substance diluted at 10% in H.O., whereas only slight erythema and edema were found after application of the test substance at 10% in water and 5% in H.O., respectively. Consistent with the 3-day reading time point, no visible change on the skin was observed after treatment with 5% of the test substance in water.
Applicant's summary and conclusion
- Interpretation of results:
- other: inconclusive
- Remarks:
- Criteria used for interpretation of results: EU
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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