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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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles. No data on analytical purity of the test substance.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Determination of skin irritation potential in the human 4-h patch test
- Author:
- Basketter, D.A. et al.
- Year:
- 2 004
- Bibliographic source:
- Contact Dermatitis 51(1): 1-4
Materials and methods
- Type of study / information:
- A single application closed patch epicutaneous test under occlusion was performed in 29 volunteers for a period of up to 4 h to determine the skin irritating potential of the test substance.
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Guidelines for the Assessment of Skin Tolerance of Potentially Irritant Cosmetic Ingredients (COLIPA, 1997)
- Deviations:
- yes
- Remarks:
- no data on analytical purity of the test substance; a volume of 0.2 mL of the test substance instead of the recommended 0.07 to 0.1 mL was applied to the skin
- GLP compliance:
- not specified
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): Tween 80
- Analytical purity: no data
Constituent 1
Constituent 2
Method
- Ethical approval:
- not specified
- Details on study design:
- The patch test procedure involved application of 0.2 mL of the test substance on a 25 mm plain Hill Top Chamber containing a Webril pad (Hill Top Companies, Cincinnati, Ohio, USA) to the skin of the upper outer arm of 29 human volunteers for up to 4 h. To avoid the production of unacceptably strong reactions, the test substance was applied progressively from 15 and 30 min through 1, 2, 3 and 4 h. Each progressive application was performed at a new skin site.
Treatment sites were assessed for the presence of irritation using a 4 point scale (Table 1 under “Any other information on materials and methods incl. tables) at 24, 48 and 72 h after patch removal.
A volunteer with a (+) or greater reaction at any of the assessments was considered to have demonstrated a positive irritant reaction, and treatment with the causative substance did not proceed on that person.
For panellists with a (+) or greater response at application times of less than 4 h to a particular test substance, it was assumed that they would present a stronger irritant reaction if exposed for 4 h. However, once a + or greater response was obtained, there was no need to subject these panellists to further treatment with that substance. In evaluating the results, what was measured was the number of panellists who had, or would have had, a positive irritant reaction after a 4-h exposure.
The interpretation of the results was done by statistical comparison of the data with a concurrent positive control (20% sodium dodecyl sulphate (SDS)) in the same panel of volunteers.
The basis for the classification decisions on the prospective human data was as follows: where the incidence of positive irritation reactions to the undiluted test substance was significantly greater than or not significantly different (using Fisher’s exact test) than the level of reaction in that same panel of volunteers to 20% SDS, the substance should be classified as irritant to skin; where the level of reaction was substantially and significantly lower than the response to SDS, then the substance was not classified. - Details on exposure:
- TYPE OF EXPOSURE: epicutaneous, occlusive
EXPOSURE LEVELS: undiluted test substance
EXPOSURE PERIOD: up to 4 h (applied progressively from 15 and 30 min through 1, 2, 3 and 4 h)
POSTEXPOSURE PERIOD: 24, 48 and 72 h
DESCRIPTION OF EXPOSURE GROUPS:
- Number of subjects exposed: 29 healthy volunteers
Results and discussion
- Results:
- Only in 1/29 (ca. 3%) individuals a positive irritant reaction to the test material was observed. In contrast, 24/29 (ca. 83%) individuals from the same panel showed a positive irritant reaction to the 20% sodium dodecyl sulphate control. As the reactions to the test substance were substantially and significantly lower than the response to SDS, the substance was not considered to be a human skin irritant.
Applicant's summary and conclusion
- Conclusions:
- After the 4-h exposure period, the undiluted test substance was not irritating to human skin.
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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