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EC number: 231-493-2 | CAS number: 7585-39-9
- 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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Report with some details lacking
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The purpose of the test was to determine the irritation and / or sensitization potential of the test product after repeated application under occlusive patch test conditions to the skin of human subjects (non-exclusive panel). The 9 Repeated Insult (occlusive) Patch Test (9 RIPT) was conducted as follows:
The amount of test material applied to each test patch was approximately 0.2 g.
Th. test material was placed onto Parke-Davis Readi-Bandage occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.
The subjects removed the patch 24 hours after application. Twenty-four hour rest peri-ods followed the Tuesday and Thursday removals and 48-hour rest periods followed the Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated until nine (9) applications of the test material had been made.
Procedural ly, if a subject develops a positive reaction of a 2-level erythema or greater during the Induction Phase or, at the discretion of the Study Director, if the skin re-sponse warrants a change in site, the patch would be applied to a previously unpatched adjacent site for the next application. If a 2-level reaction (or greater) occurs on the new site, no further applications would be made. However, any reactive subjects would be subsequently challenged with the test material.
After a rest period of 15 to 19 days (no further application of the test material, the chal-lenge patch was applied to a previously unpatched (virgin) site. The site was scored 24 and 48 hours after application. The panelists were asked to report to the laboratory any delayed reaction which might have occurred after the last reading. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Cycloheptapentylose
- EC Number:
- 231-493-2
- EC Name:
- Cycloheptapentylose
- Cas Number:
- 7585-39-9
- Molecular formula:
- C42H70O35
- IUPAC Name:
- 5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.2~3,6~.2~8,11~.2~13,16~.2~18,21~.2~23,26~.2~28,31~]nonatetracontane-36,37,38,39,40,41,42,43,44,45,46,47,48,49-tetradecol (non-preferred name)
- Details on test material:
- not available
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 55
- Sex: 1 male, rest female
- Age: not confirmed
- Race: no data
- Demographic information: no data - Clinical history:
- no data
- Controls:
- no
- Route of administration:
- dermal
- Details on study design:
- The purpose of the test was to determine the irritation and / or sensitization potential of the test product after repeated application under occlusive patch test conditions to the skin of human subjects (non-exclusive panel). The 9 Repeated Insult (occlusive) Patch Test (9 RIPT) was conducted as follows:
The amount of test material applied to each test patch was approximately 0.2 g.
Th. test material was placed onto Parke-Davis Readi-Bandage occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.
The subjects removed the patch 24 hours after application. Twenty-four hour rest peri-ods followed the Tuesday and Thursday removals and 48-hour rest periods followed the Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated until nine (9) applications of the test material had been made.
Procedural ly, if a subject develops a positive reaction of a 2-level erythema or greater during the Induction Phase or, at the discretion of the Study Director, if the skin re-sponse warrants a change in site, the patch would be applied to a previously unpatched adjacent site for the next application. If a 2-level reaction (or greater) occurs on the new site, no further applications would be made. However, any reactive subjects would be subsequently challenged with the test material.
After a rest period of 15 to 19 days (no further application of the test material, the chal-lenge patch was applied to a previously unpatched (virgin) site. The site was scored 24 and 48 hours after application. The panelists were asked to report to the laboratory any delayed reaction which might have occurred after the last reading.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: no evidence of any effect.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: all
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- A total of 55 subject. completed the test; 3 subjects discontinued for personal reasons unrelated to the conduct of the study.
Discussion or Conclusions portions of the study.
Scattered, transient. barely perceptible to mild (1-level) non-specific patch test re-sponses were observed on 3/55 test panelists (subject nos.6, 39, 41) during the induc-tion or challenge phase of the study. Non. of the non-specific response were irritant or allergic in nature.
Under the conditions of a repeated insult occlusive patch test beta Cyclodextrin did not induce irritation or allergic contact dermatitis in human subjects.
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