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EC number: 423-630-1 | CAS number: 62435-71-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The animal test was performed to meet requirements in China
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 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Remarks:
- China National Accreditation Services for Conformity Assessment (CNAS) and proved to be in compliance with CNAS/CL01:2006 'Accreditation Criteria for Testing and Calibration Laboratories
Test material
- Reference substance name:
- -
- EC Number:
- 423-630-1
- EC Name:
- -
- Cas Number:
- 62435-71-6
- Molecular formula:
- C7H14O2
- IUPAC Name:
- 2-(ethoxymethyl)oxolane
- Details on test material:
- - Clear colourless liquid
- Sample no: ZL0902374
- Soluble in water and plant oil
- Supplied by Thomas Swan & Co,. Ltd. and kept in its original container at room temperature in the Test substance Store Room.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Supplier: Guangdong Medical Laboratory Animal Center [ certified animal number "SCXK (Gunagdong) 2008-0002"].
- Acclimatisation: Five days prior to the experiment in the opbservation room.
- Identification of animals: Tags marked with animal number and treatment details were attached to cages. Each animal was given a unique number.
- Body weight: 2.5 - 3.0kg
- Test Room: in the center
- Animal house condition: The test facility was an air-conditioned room with 12 hours artifical fluorescent light and 12 hours dark
- Temp range: 19~25°C
- Humidity Rabge: 40~70%
- Caging: Stainless steels grid rabbit cages were used, and the animals were housed individually.
- Water supply: Each cage was supplied with a stainless steel nozzle which would supply tap water in spots.
- Sanitation: Auto-flushing device was used to keep the condition clean.
- Food and Water: Standard pellet feed supplied by Guangdong Medical Laboratory Aniaml Center and tap water were provided to the animals
-Freq. of providing feed and drinking water: Both drinking water and feed were provided ad libitum.
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- - Known weight of 0.1mL of the test substance was administered to one eye of a rabbit and the opposite eye was applied as control (2/sex).
- Duration of treatment / exposure:
- - Following the dosing, the rabbits were observed for Eye Irritation on conjunctiva, iris and cornea at the 1st, 24th, 48th, 72nd hour and on the 4th , 7th day.
- Observation period (in vivo):
- - Following the dosing, the rabbits were observed for Eye Irritation on conjunctiva, iris and cornea at the 1st, 24th, 48th, 72nd hour and on the 4th , 7th day.
( The observation period can be prolonged to 21 days if lesion is not clear. ) - Number of animals or in vitro replicates:
- 2 Male and 2 Female
- Details on study design:
- - Prep. of test substance: Raw substance was used.
- Test Procedure: both eyes of animal were exmained and identified to be normal before test. 0.1ml of test material was administered to one eye of a rabbit and the opposite eye was applied as the control. The eyes were kept unwashed until 24 hours later and readings were made at the 1st, 24th, 48th, 72nd hour, and on the 4th, 7th day post application. The observation period can be prolonged to 21 days if lesion is not clear. Weighted integral, total integrals, average of total integrals and average of the highest total integrals in the first 4 days were figured out, then the eye irritation and its grade were evaluated according to the criterion on the Guidelines for the Testing of Chemicals.
- Dose Level: one group was set with the dose of 0.1ml, and the opposuite eye of the rabbits was applied as the control. 2 male and 2 female animals were invovled.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 29.5
- Reversibility:
- fully reversible within: 7d
- Remarks on result:
- probability of moderate irritation
- Remarks:
- Medium(++, 5th Grade)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 10
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 8
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Eye irritation:one hour after the application, excrete, engorgement and edema in conjunctiva were found in all tested eyes. The injury in conjunctiva had differente severity, and some animals recovered after 72h~4d, while the rest on the 7th day. Engorgement in tested irs was found in a few animals on hour after the application, and recovered on the 7th day; while some were found in a few animals 24 hours after the application, and recovered 48 hours later. Most animals had nubecula in more than 3/4 areas of the tested cornea 24 hours after application. The nubecula in a few animals recovered 72 hours later, while the rest got better 72h~4d later, and recovered on the 7th day. No irritation was observed in the controlled eyes.
Index of the score: The average of the highest total integrals in the forst 4 days was 29.5; the average of the total integrals was ZERO on the 7th day, and more than half of the animals had the total integrals less-than-or-equal-to 10.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The average of the highst total integrals in the first 4 days was 29.5; the average of total integrals was ZERO on the 7th day, and more than half of the animals had the total integrals less0than-or-equal-to 10.
Based on guidelines for the testing of chemicals, the irritancy potency of Ethyl Tetrahydrofurfuryl Ether to eyes is estimated to be MEDIUM (++, the 5th grade).
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