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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: human patch testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To determine by epidermal contact the primary irritation potential of the test material, ColaMoist.
53 subjects, male and female age range 16 - 77 years were selected for this evaluation. 52 out of the 53 completed the study. The remaining person discontinued for personal reasons unrelated to the study.
Participants had to be over 16 and have no visible skin disease or skin complaint which might be confused with a reaction.
They were prohibited to use topical or systemic steroids and/or antihistamines for at least 7 days prior to the study initiation.
Completion of a medical history form and a consent form were required.
Exclusion criteria included; ill health, taking medication, pregnancy or nursing, a history of adverse reactions with cosmetics or personal care products. - GLP compliance:
- no
Test material
- Reference substance name:
- 2-hydroxy-N,N'-bis(2-hydroxyethyl)-N,N,N',N'-tetramethylpropane-1,3-diaminium dichloride
- EC Number:
- 807-137-2
- Cas Number:
- 110528-94-4
- Molecular formula:
- 2-hydroxy-N,N'-bis(2-hydroxyethyl)-N,N,N',N'-tetramethylpropane-1,3-diaminium dichloride
- IUPAC Name:
- 2-hydroxy-N,N'-bis(2-hydroxyethyl)-N,N,N',N'-tetramethylpropane-1,3-diaminium dichloride
- Test material form:
- other: aqueous solution
- Details on test material:
- No batch data available. Test material assumed to be the 70% active commercially available material undiluted.
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: male and females age range 16 - 77 years
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: no preparation noted. Cleanliness assumed.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.2 ml of the ColaMoist 70% active solution was applied to the 3/4 x 3/4 inch absorbent pad of an adhesive dressing. (The dressings were supplied by TruMed Technologies of Burnsville, MN, USA). The patch was applied to the upper back between the scapulae of each individual.
- Duration of treatment / exposure:
- The test material remained in contact with the skin for a total of 48 hours.
- Observation period:
- The site was observed after 48 hours following removal of the patch and then re-evaluated after 72 hours
- Number of animals:
- 52 humans
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: No subject showed any visible skin reaction from the test after 48 hours and also after 72 hours
- Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the conditions of the test, ColaMoist 200 at 70% active solution did not indicate a potential for dermal irritation
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