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EC number: 458-610-1 | CAS number: 60466-73-1
- 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:
- 20 December 2004 to 03 January 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD Guideline 405 with deviations: age at study initiation, feeding conditions not reported. These deviations do not affect the quality of the study and are not considered to be relevant. The substance is considered to be adequately characterised.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- yes
- Remarks:
- age at study initiation, feeding conditions not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive n° 2004/73/EC.
- Deviations:
- yes
- Remarks:
- age at study initiation, feeding conditions not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected 2004-07-01 / Signed 2004-09-13
Test material
- Reference substance name:
- (3R)-3-benzyloxane
- Molecular formula:
- C12 H16 O
- IUPAC Name:
- (3R)-3-benzyloxane
- Reference substance name:
- (3S)-3-benzyloxane
- Molecular formula:
- C12 H16 O
- IUPAC Name:
- (3S)-3-benzyloxane
- Test material form:
- liquid
- Remarks:
- clear
- Details on test material:
- - Physical state: Colourless translucent liquid, characteristic odour
- Storage conditions : room temperature
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste – F40260 Linxe - FRANCE
- Weight at study initiation: 2.34-2.75 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: No data
- Water: No data
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20-21 °C
- Humidity: 30-52 %
IN-LIFE DATES: 20 December 2004 to 03 January 2005
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye serving as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- No washing was done
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1, 24, 48, 72 h and Day 4 to Day 11 following treatment, according to a numerical evaluation.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- TREATMENT
A volume of 0.1 mL of the pure test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: According to OECD guideline 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: Day 11
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: Day 7
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: Day 8
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: Day 7
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: Day 4
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: Day 6
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: Day 5
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: Day 4
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: Day 7
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a moderate enanthema, noted 24 hours after the test product instillation and totally reversible between the 7th and the 9th day of the test, associated with a slight to moderate chemosis, noted 24 hours after the test product instillation and totally reversible between the 3rd and the 8th day of the test ;
- at the corneal level: a moderate opacity, registered 24 hours after the test product instillation, and totally reversible between the 5th and the 12th day of the test,
- at the iris level: a congestion, registered 24 hours after the test product instillation in 2 animals, and between the 5th and the 7th day of the test in one animal - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Individual and mean scores of conjunctivae, iris and cornea
Time / Animal
|
Cornea
|
Iris
|
Conjunctivae
|
|||||||||
redness
|
chemosis
|
|||||||||||
1 (A6389) |
2 (A6394) |
3 (A6395) |
1 (A6389) |
2 (A6394) |
3 (A6395) |
1 (A6389) |
2 (A6394) |
3 (A695) |
1 (A6389) |
2 (A6394) |
3 (A6395) |
|
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
1 |
1 |
1 |
1 |
24 h |
2 |
2 |
2 |
1 |
1 |
0 |
2 |
2 |
2 |
1 |
2 |
1 |
48 h |
2 |
2 |
1 |
0 |
0 |
0 |
1 |
2 |
1 |
1 |
1 |
0 |
72 h |
2 |
1 |
1 |
0 |
0 |
0 |
1 |
2 |
1 |
1 |
1 |
0 |
D4 |
2 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
D5 |
2 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
D6 |
2 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
D7 |
1 |
- |
0 |
0 |
- |
0 |
1 |
- |
0 |
0 |
- |
0 |
D8 |
1 |
- |
- |
0 |
- |
- |
0 |
- |
- |
0 |
- |
- |
D9 | 1 | - | - | 0 | - | - | 0 | - | - | 0 | - | - |
D10 | 1 | - | - | 0 | - | - | 0 | - | - | 0 | - | - |
D11 | 0 | - | - | 0 | - | - | 0 | - | - | 0 | - | - |
Mean 24/48/72 h | 2.0 | 1.7 | 1.3 | 0.3 | 0.3 | 0.0 | 1.3 | 2.0 | 1.3 | 1.0 | 1.3 | 0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, the test substance is classified in Category 2 (H319: Causes serious eye irritation) according to the criteria of the Regulation EC No. 1272/2008 (CLP) and classified in Category 2A (irritating to eyes) according to the GHS.
- Executive summary:
In an eye irritation study conducted according to OECD 405 Guideline and in compliance with GLP, test substance was instilled as supplied, into the eye of 3 New Zealand rabbits at the dose of 0.1 mL, the other eye remained untreated serving as control. The lids were then gently held together for about one second in order to prevent loss of the test substance. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and 4 to 11 days after treatment and graded according to the Draize method.
The ocular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a moderate enanthema, noted 24 hours after the test product instillation and totally reversible between the 7th and the 9th day of the test, associated with a slight to moderate chemosis, noted 24 hours after the test product instillation and totally reversible between the 3rd and the 8th day of the test ;
- at the corneal level: a moderate opacity, registered 24 hours after the test product instillation, and totally reversible between the 5th and the 12th day of the test,
- at the iris level: a congestion, registered 24 hours after the test product instillation in 2 animals, and between the 5th and the 7th day of the test in one animal.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 2.0, 1.7, 1.3 for cornea score; 0.3, 0.3, 0.0 for iris score; 1.3, 2.0, 1.3 for conjunctivae score and 1.0, 1.3, 0.3 for chemosis score.
Under the test conditions, the test substance is classified in Category 2 (H319: Causes serious eye irritation) according to the criteria of the Regulation EC No. 1272/2008 (CLP) and classified in Category 2A (irritating to eyes) according to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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