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Diss Factsheets
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EC number: 201-781-2 | CAS number: 87-89-8
- 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
- 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:
- no guideline followed
- Principles of method if other than guideline:
- The primary dermal irritation of the test substance was examined in guinea pigs.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Myo-inositol
- EC Number:
- 201-781-2
- EC Name:
- Myo-inositol
- Cas Number:
- 87-89-8
- Molecular formula:
- C6H12O6
- IUPAC Name:
- cyclohexane-1,2,3,4,5,6-hexol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Purity: not reported
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC, Inc. (3371-8 Koto-cho, Harnamatsu-shi, Shizuoka, Japan)
- Age at study initiation: 6 weeks
- Weight at study initiation: not reported
- Housing: Aluminum cages (W 350 mm x D 400 mm x H 230 mm). Animals were kept in groups of 5 or 6 per cage during the quarantine period and in groups of 5 per cage during the study period.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±2°C
- Humidity (%): 50±10%
- Air changes (per hr): 17 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours/dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
VEHICLE
- Amount(s) applied (volume or weight with unit): physiological saline
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): physiological saline
POSITIVE CONTROL: No - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 3, 24, and 48 hours after patch removal
- Number of animals:
- 5
- Details on study design:
- TEST SITE
- Area of exposure: lateral abdomen (normal and abraded skin)
- % coverage: not reported
- Type of wrap if used: non-permeable adhesive plaster and elastic adhesive plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
OBSERVATION TIME POINTS: 3, 24, and 48 hours
SCORING SYSTEM:
- Method of calculation: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2, 3, 4, 5
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2, 3, 4,5
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 2, 3, 4, 5
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 2, 3, 4, 5
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 2, 3, 4, 5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2, 3, 4, 5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin reaction was observed at any observation time in either the normal skin or abraded skin similarly to the control group.
- Other effects:
- No abnormality was observed in general conditions dnring the stndy period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritation was observed.
- Executive summary:
Skin irritability of the test substance was examined using five albino Hartley guinea pigs. Normal and abraded skin regions were provided on the shaven lateral abdomen of each animal. The pure test substance as a white powder was used in the study with dropping physiological saline on it in order to improve contact with the skin. For administration, 0.1 g of the test substance was placed on the cloth portion of the adhesive plaster for patch test with a drop of physiological saline on it and applied as a 24-hour closed patch using an adhesive sponge plaster and elastic plaster. Irritation reactions were observed at 3, 24 and 48 hours after removal of the patch in accordance with the Draize’s assessment criteria. As a result, no abnormality was observed in general conditions during the study period. No skin reaction was observed at any observation time in either the normal skin or abraded skin similarly to the control group, and the primary irritation index (P.I.I.) was 0.
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