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Diss Factsheets
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EC number: 807-137-2 | CAS number: 110528-94-4
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The most standardised method used today, to establish the sensitizing potency of chemicals, is the local lymph node assay (LLNA). Historically the Human Repeated Insult Patch Test (HRIPT), a test conducted in healthy controls, has been widely used, particularly in the US. As the end-point is prevention of human disease, human data, if available, have a particular importance and impact for the final decisions. The test numbers were restricted in this case to nine individuals, which is probably not sufficient for the test to be truly representative hence the reliability score of 2 rather than 1.
- Qualifier:
- according to guideline
- Guideline:
- other: Human Repeated Insult Patch Test (HRIPT)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The upper arm served as the treatment area. Approximately 0.5 ml of the test material was applied to the 1” X 1/2” absorbent pad portion of an adhesive dressing. This was then applied to the treatment site to form a semi-occlusive patch.
Patches were applied three times per week (e.g., Monday, Wednesday, and Friday) for a total of nine applications. The site was marked to ensure the continuity of patch application. Participants were instructed to remove all patches 24 hours after application. If any site exhibited a moderate (2-level) reaction during the induction phase, application was moved to an adjacent area.
Rest periods consisted of twenty-four hours following each Tuesday and Thursday removal, and forty-eight hours following each Saturday removal.
Approximately two weeks after the final induction patch application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site, following the same procedure described for induction. The patch was removed and the site was evaluated twenty-four and seventy-two hours after application. - GLP compliance:
- no
- Type of study:
- patch test
- Species:
- human
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 10% active material
- Concentration / amount:
- 10% active material
- No. of animals per dose:
- Nine persons took part in the testing
- Details on study design:
- Use repetitive epidermal contact to determine the potential of the title compound to induce primary or cumulative irritation and/or allergic contact
sensitization. - Challenge controls:
- Approximately two weeks after the final induction patch application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site, following the same procedure described for induction. The patch was removed and the site was evaluated twenty-four and seventy-two hours after application.
- Positive control substance(s):
- not required
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Approximately 0.5 ml of the 10% active test material was applied to the 1” X 1/2” absorbent pad portion of an adhesive dressing. This was then applied to the treatment site to form a semi-occlusive patch.
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Approximately 0.5 ml of the 10% active test material was applied to the 1” X 1/2” absorbent pad portion of an adhesive dressing. This was then applied to the treatment site to form a semi-occlusive patch.. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- ~0.5ml of 10% active material
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: ~0.5ml of 10% active material. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: none.
- Reading:
- other: 9th reading
- Hours after challenge:
- 216
- Group:
- test chemical
- Dose level:
- ~0.5ml of 10% active material
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- Barely perceptible or spotty erythema
- Remarks on result:
- other: Reading: other: 9th reading. . Hours after challenge: 216.0. Group: test group. Dose level: ~0.5ml of 10% active material. No with. + reactions: 1.0. Total no. in groups: 9.0. Clinical observations: Barely perceptible or spotty erythema.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the conditions of this study, test material Cola®Moist 200, lot # 21035J08, did not indicate a potential for dermal irritation or allergic contact sensitization.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Similar tests carried out on a larger sample of humans (200) using a solution of a read-across substance (choline chloride) also suggested that there was no sensitisation effect from this type of substance.
Migrated from Short description of key information:
Under the conditions of this study, test material Cola®Moist 200, lot # 21035J08, did not indicate a potential for dermal irritation or allergic contact sensitization.
Justification for selection of skin sensitisation endpoint:
Key study conducted on humans usng the HRIPT test method and a 70% active solution of the ColaMoist 200 material
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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