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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 April 2002 - 12 April 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In vivo information of 2002 is used for the assessment of the eye irritation.
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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- January 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 / tissue source
- Species:
- rabbit
- Strain:
- other: albino female rabbits of the stock Chbb:GM(SPF) - Littlerussian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG
- Age at study initiation: not indicated
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: individually in PPO cages with perforated floor
- Diet: A pelleted complete rabbit diet "Altromin 2123" from Altromin, ad libitum
- Water: The animals had 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: 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after treatment
- Number of animals or in vitro replicates:
- The study was initiated with one rabbit. Since no marked eye irritation was seen in this animal three more rabbits were included in the study.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
After rinsing with 20 ml 0.9 % sodium chloride solution the eyes were examined again using UVlight to detect possible corneal damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- - One hour after the application of the test article all animals showed some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal. A diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge different from normal were observed in one animal.
- 24 hours after the application of the test article two animals showed some conjunctival vessels definitely injected and a swelling above normal. Some conjunctival vessels definitely injected were observed in the third animal, whereas the fourth animal did not show any signs of eye irritation.
- 48 and 72 hours after the application of the test article all animals were free of any signs of eye irritation.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not an eye irritant.
- Remarks:
- In accordance Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- Based on the results of an eye irritation study, performed according to OECD 405 guideline and under GLP, the substance is considered not to be an eye irritant.
- Executive summary:
A study, performed according to OECD 405 guideline and under GLP, was conducted to assess the potential for the substance to be eye irritating. Four albino rabbits were used: one rabbit initially was exposed to the substance and, since no marked eye irritation was seen in this animal, three more rabbits were included in the study. An amount of 0.1 mL of the substance was applied directly to one eye and the other, untreated, eye was used as control. Observations were made 1 hours, 24 hours, 48 hours and 72 hours after dosing. The effects were scored according to Draize. No effects were observed on the cornea and the iris. Effects on the conjunctivae were observed in all animals from 1 hour after treatment, these effects were fully reversed within 48 hours. Based on the results, the substance is considered not to be an eye irritant and does not need to be classified according to Regulation (EC) No. 1272/2008 and its amendments.
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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