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EC number: 228-536-2 | CAS number: 6290-17-1
- 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:
- 11 March 2002 - 22 March 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- An in vivo study was performed at 2002.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate
- EC Number:
- 228-536-2
- EC Name:
- Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate
- Cas Number:
- 6290-17-1
- Molecular formula:
- C9H16O4
- IUPAC Name:
- ethyl 2-(2,4-dimethyl-1,3-dioxolan-2-yl)acetate
- Test material form:
- liquid
1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino rabbits (Chbb:HM)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: stock Chbb:HM(SPF) - Littlerussian, BI Pharma KG
- Age at study initiation: not indicated
- Weight at study initiation: 2.5 - 3.1 kg
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet: complete rabbit diet "Altromin 2123" from Altromin, ad libitum
- Water: free access to bottles with domestic quality drinking water acidified
with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: no
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55 % ± 15 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: not indicated
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Ethanol/Diethylphthalate 1:1
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 0% (vehicle), 1%, 10%, 25%, 50% and 100% (v/v) in the vehicle.
0.5 mL of the test substance or vehicle was applied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: adhesive Gothaplast tape
REMOVAL OF TEST SUBSTANCE
- Washing: with mild soap and lukewarm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS: 1 hour, 24 hours, 48 hours and 72 hours after termination of exposure.
SCORING SYSTEM: according to the scale shown in table 1 and 2 ('Any other information on materials and methods, incl. tables').
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- 1, 24, 48 and 72 hours after the termination of exposure none of the animals showed skin reactions.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not a skin irritant
- Remarks:
- According to EU CLP (EC. No. 1272/2008 and its amendments).
- Conclusions:
- Under the experimental conditions described in this report, no skin irritation was observed in rabbits after exposure to the substance.
- Executive summary:
In this study performed according to OECD TG 404 guideline and GLP principles, 4 female rabbits were observed for skin irritation after exposure to the substance. Concentrations of 0% (EtOH/DEP, vehicle), 1%, 10%, 25%, 50% were tested with vehicle and 100% (v/v) was used undiluted. An amount of 0.5 mL substance was applied to clipped skin with a surface of 2.5 x 2.5 cm. After 4 hours of exposure, the substance was removed and the skin was washed. Observations were made for 72 hours after exposure. The animals were scored for erythema and oedema formation. No skin irritation was observed and the mean erythema and oedema scores for all animals were 0. Based on the results, the substance is considered not to be a skin irritant and does not need to be classified for skin irritation according to Regulation (EC) No. 1272/2008 and its amendments.
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