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EC number: 202-888-7 | CAS number: 100-79-8
- 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
- Study period:
- From 21 July 2009 to 06 November 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline 404 without any deviation.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 19 November 2008
Test material
- Reference substance name:
- 2,2-dimethyl-1,3-dioxolan-4-ylmethanol
- EC Number:
- 202-888-7
- EC Name:
- 2,2-dimethyl-1,3-dioxolan-4-ylmethanol
- Cas Number:
- 100-79-8
- Molecular formula:
- C6H12O3
- IUPAC Name:
- (2,2-dimethyl-1,3-dioxolan-4-yl)methanol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): PEX-01; 2,2-Dimetil-4-Hidroximetil-1,3-Dioxolano
- Physical state: Clear liquid
- Analytical purity: 99.5%
- pH of test substance = 6
- Composition of test material, percentage of components: 99.9% 2,2-Dimethyl-1,3-dioxolane-4-methanol; water: 0.02%; Acidity (Acetic acid): 0.0021%
- Lot/batch No.: 081001
- Expiration date of the lot/batch: 01 October 2009
- Stability under test conditions: Stable at room temperature and under normal conditions of use
- Storage condition of test material: at room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Natanael Alves Ferreira
- Age at study initiation: Approximately 3 months
- Weight at study initiation: At least 1.5 kg
- Housing: galvanized metal cages (Gaiolas Ipanema, 50 x 50 x 50 cm)
- Diet: Commercial diet for the species (Guabi, Santa Fé), ad libitum
- Water: filtered water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: from 19ºC to 21ºC
- Humidity: 68%
- Air changes: No data
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: 24 August 2009 To: 27 August 2009.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Non-treated area of the right flank was used as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (weight with unit): 0.5 mL
- Concentration (if solution): Undiluted test item - Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Area of approximately 6 cm2 of the left flank of the animals.
- Type of wrap if used: Test item (0.5 mL) was applied to the shaved skin covered with an aluminum foil and gauze patch held in place with a non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- At the end of 4 hours, residual test substance was removed using deionized water.
SCORING SYSTEM: According to the Draize method (OECD, 2002)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Neither edema nor erythema was observed during the observation period in the treated areas of all rabbits at 24, 48 and 72 hours.
- Other effects:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance PEX-01 is not classified for skin irritation according to the Regulation (EC) N° 1272-2008 (CLP) and GHS UN.
- Executive summary:
In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three male New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted 2,2-Dimethyl-1,3-dioxolane-4-methanol under a semi-occlusive gauze dressing. The test item was applied to the shaved skin under a gauze patch held in place for 4 hours. Animals were observed at 1, 24, 48 and 72 hours after removal of test substance for signs of erythema and edema.
Neither edema nor erythema was observed during the observation period in the treated areas of all rabbits at 24, 48 and 72 hours. In this study, 2,2-Dimethyl-1,3-dioxolane-4-methanolis not a skin irritant on male rabbits.
Under the test conditions, the submitted substance 2,2-Dimethyl-1,3-dioxolane-4-methanol is not classified for skin irritation according to the Regulation (EC) N° 1272-2008 (CLP) and GHS UN.
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