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EC number: 830-086-2 | CAS number: 742087-48-5
- 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
- Remarks:
- Human Patch test survey
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 48 Hours Patch Test
- Deviations:
- not specified
- Principles of method if other than guideline:
- Determination by epidermal contact the primary irritation potential of a test material
- GLP compliance:
- no
- Remarks:
- These studies have been performed with adherence to ICH Guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR parts 50 and 56 and in accordance to standard operating procedures and applicable protocols
Test material
- Reference substance name:
- D-Glucopyranose, oligomeric, decyl octyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts
- EC Number:
- 830-086-2
- Cas Number:
- 742087-48-5
- Molecular formula:
- Substance is a UVCB - variable composition
- IUPAC Name:
- D-Glucopyranose, oligomeric, decyl octyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Prior to the initiation of this study, the test material was prepared as a 10% dilution, using distilled water
Test animals
- Species:
- human
- Strain:
- other: male / female
- Details on test animals or test system and environmental conditions:
- Fifty-three (53) subjects, male and female, ranging in age from 16 to 79 years, who qualified were selected for this evaluation. All (53) subjects completed this study.
The following criteria were used;
a. Male and female subjects, age I 6 and over.
b. Absence of any visible skin disease which might be confused with a skin reaction from the test material.
c. Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
d. Completion of a Medical History form and the understanding and signing of an Informed Consent form.
e. Considered reliable and capable of following directions
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: The upper back between the scapulae served as the treatment area. No specific preparation of the skin was detailed
- Vehicle:
- water
- Remarks:
- 10% dilution in distillated water
- Controls:
- yes
- Amount / concentration applied:
- Approximately 0.2 ml of the test material, or an amount sufficient to cover the contact surface, was applied to the l " x l" absorbent pad portion of a clear adhesive dressing*. When secured to the appropriate treatment site, this dressing formed a semi-occlusive patch.
The test material remained in contact with the skin for a total of forty-eight hours. This site was then evaluated for gross changes. Absence of any visible skin change was assigned a zero value. The test site was reevaluated at seventy-two hours. - Duration of treatment / exposure:
- 48 hours
- Observation period:
- 48 hours and 72 hours
- Number of animals:
- 53 subjects
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- based on visible skin reaction
- Basis:
- mean
- Remarks:
- 53 human subjects
- Time point:
- other: 48/72 hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no data
- Remarks:
- no effect seen so no reversibility required
- Remarks on result:
- no indication of irritation
- Remarks:
- Observations were carried out after 2 and 3 days
- Irritation parameter:
- edema score
- Remarks:
- based on visible skin reaction
- Basis:
- mean
- Remarks:
- 53 human subjects
- Time point:
- other: 48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable. No effect seen so no reversblity required
- Remarks on result:
- no indication of irritation
- Remarks:
- Observation taken 2 and 3 days after application
- Irritant / corrosive response data:
- The test material remained in contact with the skin for a total of forty-eight hours. This site was then evaluated for gross changes. Absence of any visible skin change was assigned a zero value - see scoring system below. The test site was re-evaluated at seventy-two hours.
Any other information on results incl. tables
The scoring system that was applied used the following descriptions
0: Barely perceptible or spotty erythema
1: Mild erythema covering most of the test site
2: Moderate erythema, possible presence of mild edema
3: Marked erythema, possible edema
4: Severe erythema, possible edema, vesiculation, bullae and/or ulceration
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No visible skin reaction.
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