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Diss Factsheets
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EC number: 201-210-7 | CAS number: 79-50-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in full compliance with OECD 437 testing guideline and under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
- EC Number:
- 201-210-7
- EC Name:
- (±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
- Cas Number:
- 79-50-5
- Molecular formula:
- C6H10O3
- IUPAC Name:
- (±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
- Reference substance name:
- RS-Pantolactone
- IUPAC Name:
- RS-Pantolactone
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): RS-Pantolactone
- Analytical purity: 99.8%
- Lot/batch No.: Bx TL 00905003
- Expiration date of the lot/batch: June 30, 2011
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: bovine cornea
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 20% in saline
- Amount: 0.75 mL
CONTROLS:
- Concentration (negative control): pure saline
- Concentration (positive control): 10% (w/v) Benzalconium chloride in saline
- Amount: 1.0 mL - Duration of treatment / exposure:
- 240 minutes (± 5 minutes)
- Number of animals or in vitro replicates:
- 3 corneae per group (test item, negative & positive control)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): by replacing the test & control solutions by fresh cMEM
TOOL USED TO ASSESS SCORE:
1) Opacity measurement (Opacitometer)
2) Permeability (Incubation with Na-fluorescein solution for 90 minutes; OD measurement of the posterior compartment at 490 nm)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 16.07
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: in vitro irritation score (IVIS)
- Basis:
- mean
- Score:
- 0.13
- Reversibility:
- not specified
- Remarks on result:
- other: negative control
- Irritation parameter:
- other: in vitro irritation score (IVIS)
- Basis:
- mean
- Score:
- 124.56
- Reversibility:
- not specified
- Remarks on result:
- other: positive control
- Irritation parameter:
- other: In vitro irritation score (IVIS)
- Basis:
- mean
- Score:
- 16.07
- Reversibility:
- not specified
- Remarks on result:
- other: Test item
Any other information on results incl. tables
Test group | Opacity value | Permeability | In vitro score | Mean in vitro score | Proposed in vitro irritation scale (INVITTOX classifiaction) | ||
Mean | Mean | ||||||
Negative control | 0 | -0.67 | 0.050 | 0.053 | 0.76 | 0.13 | Non eye irritant |
0 | 0.049 | 0.73 | |||||
-2 | 0.060 | -1.10 | |||||
Positive control | 155.67 | 123.00 | 0.117 | 0.104 | 157.42 | 124.56 | Very severe eye irritant |
112.67 | 0.160 | 115.06 | |||||
100.67 | 0.036 | 101.20 | |||||
20% RS-Pantolactone in saline | 6.67 | 13.00 | 0.116 | 0.204 | 8.41 | 16.07 | Mild eye irritant |
14.67 | 0.187 | 17.47 | |||||
17.67 | 0.310 | 22.32 | |||||
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the results of this study, the test item RS-Pantolactone is not to be classified as Eye Damage Category 1 according to UN GHS.
Based on the results of this study, the test item RS-Pantolactone is not to be classified as Not Classified according to UN GHS. - Executive summary:
A Bovine Corneal Opacity and Permeability Test (BCOP) has been performed on the test item RS-Pantolactone. The test has been performed in compliance with the OECD 437 guideline and under GLP.
The test item produced a mean in vitro irritation score (IVIS) of 16.07. Appropriate positive and negative controls, which were carried along in parallel, behaved as expected.
Based on the classification criteria as in the current OECD 437 guideline (2013) and in UN GHS, the test item RS-Pantolactone is to be classified neither as Eye Damage Category 1 nor as Not classified.
Being not corrosive to the eye but producing a distinct effect in this BCOP assay, is highly likely that the test item RS-Pantolactone can be considered as eye irritant.
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