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EC number: 700-591-1 | CAS number: 82203-23-4
- 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: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-01-20 - 2012-04-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B46
- Deviations:
- no
- Principles of method if other than guideline:
- - Commission Regulation (EC) No. 761/2009, Method B.46, adopted 23. July 2009: “In Vitro Skin Irritation: Reconstructed human epidermis model test”
- OECD Guideline for the Testing of Chemicals, Version 439, 22. July 2010, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”
- ECVAM international validation study on in vitro tests for acute skin irritation: Report on the validity of the EPISKIN and EpiDerm assays and on the Skin Integrity Function Test (Altern Lab Anim. 2007 Dec; 35 (6): 559-601).
- Protocol for IN VITRO EpiDerm™ SKIN IRRITATION TEST (EPI-200-SIT), Rev. 3/23/2009, MatTek Corporation, Ashland, MA 01721, USA - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- EC Number:
- 700-591-1
- Cas Number:
- 82203-23-4
- Molecular formula:
- C20H20Cl2O6
- IUPAC Name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Details on test material:
- - Name of test material (as cited in study report): (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Physical state: solid (white powder)
- Expiration date of the lot/batch: December 2012
- Storage condition of test material: Room Temperature: (20 ± 5°C); Keep away from humidity
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- other: serum-free DMEM medium
- Details on test system:
- TEST SITE
- % coverage: 100 %
REMOVAL OF TEST SUBSTANCE
- Washing (if done): DPBS-Buffer
- Time after start of exposure: 35 min.. 60 min
SCORING SYSTEM: formazan production is calculated as % photometric absorption compared with the mean of the negative control - Control samples:
- not required
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
13.4 mg (tissue 1)
22.9 mg (tissue 2)
24.3 mg (tissue 3)
VEHICLE
- Lot/batch no. (if required): 030112TMC - Duration of treatment / exposure:
- 1h
- Duration of post-treatment incubation (if applicable):
- 35 - 60 min
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: % Formazan production
- Value:
- 135.1
- Remarks on result:
- other: threshold for irritation (>50% of negative control = non-irritant)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol showed no skin irritation potential [values are well above the treshold for irritation potential (50%)].
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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