Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-849-3 | CAS number: 86404-04-8
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 11 Feb - 20 Mar 2009
- 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:
- 2 009
- Report date:
- 2009
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A repeated insult human patch test was conducted in 50 subjects. 0.2 mL of the test substance was applied to the skin under occlusive conditions.
- GLP compliance:
- no
- Remarks:
- according to Good Clinical Practice
Test material
- Reference substance name:
- (5R)-5-[(1S)-1,2-dihydroxyethyl]-4-ethoxy-3-hydroxy-2,5-dihydrofuran-2-one
- EC Number:
- 617-849-3
- Cas Number:
- 86404-04-8
- Molecular formula:
- C8H12O6
- IUPAC Name:
- (5R)-5-[(1S)-1,2-dihydroxyethyl]-4-ethoxy-3-hydroxy-2,5-dihydrofuran-2-one
- Details on test material:
- - Name of test material (as cited in study report): VCE-1
- Substance type: Clear colorless, liquid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 50
- Sex: male and female
- Age: 18 - 79 years - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: repeated insult patch test
INDUCTION EXPOSURE
- Type of application: Occlusive
- No. of exposures: 9
- Testing/scoring schedule: Subjects were treated every Monday, Wednesday and Friday.
- Description of patch: Parke-Davis Readi-Bandage occlusive patch
- Test site: The test substance was applied to the skin on the back of each subject, between the scapulae and waist, adjacent to the spinal mid-line.
- Concentrations: Not specified
- Volume applied: 0.2 mL
- Removal of test substance: The patch was removed 24 h after application.
- Evaluation (hr after induction): 48 h after patch removal (following application on Monday and Wednesday), 72 h after patch removal (following application on Friday)
CHALLENGE EXPOSURE
- Testing/scoring schedule: Subjects were challenged approximately 2 weeks after the last induction treatment.
- Test site: The test substance was applied to a previously unpatched (virgin) test site.
- Evaluation (hr after challenge): 24 and 72 h
EXAMINATIONS
- Grading/Scoring system: The dermal responses for both the induction and challenge exposure were scored according to the following 6-point scale:
0 = No evidence of any effect
+ = Barely perceptible (minimal, faint, uniform or spotty erythema)
1 = Mild (pink, uniform erythema covering most of the contact site)
2 = Moderate (pink-red erythema uniform in the entire petechiae or papules)
3 = Marked (bright red erythema with/without petechiae or papules)
4 = Severe (deep red erythema with/without vesiculation or weeping)
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No skin reaction was observed at any time during the course of the study.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/50
- Number of subjects with negative reactions: 50/50
- Number of subjects with irritating reactions: 0/50
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test, the test substance did not cause any skin irritation or skin sensitisation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.