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EC number: 251-090-5 | CAS number: 32539-83-6
- 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
- Study period:
- Between 2000-09-25 and 2000-10-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP test following OECD test guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran
- EC Number:
- 251-090-5
- EC Name:
- 3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran
- Cas Number:
- 32539-83-6
- Molecular formula:
- C15H26O1
- IUPAC Name:
- 2H,3H,4H,5H,6H,7H,8H,9H,10H,11H,12H,13H,14H-cyclododeca[b]pyran
- Details on test material:
- - Name of test material (as cited in study report): HR 00/690946
- Substance type: active
- Physical state: liquid
- Lot/batch No.: 20081508
- Expiration date of the lot/batch: 360 days
- Stability under test conditions: yes
- Storage condition of test material: cool and dry
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Chbb:HM(SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, DE-88397 Biberach
- Weight at study initiation: 2.8-3.0 kg
- Housing: rabbits caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet (e.g. ad libitum): ad libitum "Altromin 2123" from Altromin, D-32791 Lage, Lippe
- Water (e.g. ad libitum): free access to bottles with domestic quality drinking water acidified with hydrochloric acid (pH 2.5) in order to prevent microbial growth
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): animals where in a room with filtered air
- Photoperiod (hrs dark / hrs light): 12 hours light (6 a.m. to 6 p.m.) and 12 hours darkness
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Ethanol/Diethylphthalat: 1:1
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of test article or vehicle
- Concentration (if solution): 1 %, 10 %, 25 %, 50 % and 100 %
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- skin reactions were read one hour, 24, 48 and 72 hours as well as 7, 14 and 21 days after termination of exposure
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 10*10 cm on the back
- % coverage: no data
- Type of wrap if used: layer gauze patches
REMOVAL OF TEST SUBSTANCE
- Washing (if done): mild soap and lukewarm water
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in the depth): 4
Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Well-defined oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm, extending beyond area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Erythema-formation
- Basis:
- mean
- Time point:
- other: mean individual scores 24, 48 and 72 hours-reading
- Score:
- > 0 - < 2.8
- Max. score:
- 2.8
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean individual scores 24, 48 and 72 hours-reading
- Score:
- >= 0 - <= 2.8
- Max. score:
- 2.8
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- plese, see the tables in "Attached background materials"
- Other effects:
- no effects
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the directive of the 98/98/EEC the test material in concentrations 100 % and 50 % shall be classified as skin irritating.
According to the directive of the 98/98EEC the test material in concentrations 25 %, 10 % and 1% shall not be classified as skin irritating. - Executive summary:
According to the directive of the 98/98/EEC the test material in concentrations 100 % and 50 % shall be classified as skin irritating.
According to the directive 98/98/EEC the test material in concentrations 25 %, 10 % and 1% shall not be classified as skin irritating.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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