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EC number: 271-794-6 | CAS number: 68608-66-2
- 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

Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- January 27, 2000 - March 17, 2000
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Not a validated method for determining skin irritation or skin sensitisation, but provides supporting information for “in-use” concentrations using a “standard practice” applied to ingredients for consumer formulations. It is a 9-days cumulative application for 24 hours, after which a rest period of approximately 2 weeks, a challenge patch was applied to a previously unpatched test site.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Remarks:
- (not applicable)
Test material
- Reference substance name:
- Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide
- EC Number:
- 271-794-6
- EC Name:
- Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide
- Cas Number:
- 68608-66-2
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C11 alkyl) derivs. and sodium hydroxide and chloroacetic acid
- Details on test material:
- - Physical state: aqueous solution
- Appearance: clear liquid
- Composition of test material, percentage of components: see section confidential details on test material
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- other: Informed Consent (CFR title 21, Part 50) was obtained from each human subject in the study
- Subjects:
- -A total of 109 human subjects started the study (14 males and 95 females ranging in age from 18 to 68 years)
-A total of 99 human subjects completed all phases of this study - Clinical history:
- No data
- Controls:
- Not applicable
- Route of administration:
- dermal
- Details on study design:
- - Amount(s) applied (volume or weight with unit): 0.2 mL
- Concentration (if solution):
Separately reported: 0.5% of the aqueous solution (solid content: 0.15%)
INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hours
CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hours
Results and discussion
- Results of examinations:
- no irritating nor sensitisation reactions observed
Any other information on results incl. tables
-Ten subjects (10/109) discontinued for personal reasons unrelated to the conduct of the study
-Scattered, transient, barely perceptible (+) to mild (1-level) non-specific patch test responses were observed on nine test panelists during the induction phase of the study
-During challenge phase, two test panelists exhibited barely perceptible responses at the 24- and/or 48-hour evaluations. There was no reactivity observed on either subject by the 96-hour evaluation
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of a repeated insult (occlusive) patch test procedure, a 0.5% aqueous dilution of the aqueous solution of the test material (solid content 0.15%) did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.
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