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EC number: 226-685-8 | CAS number: 5451-76-3
- 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:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5471-76-3
- IUPAC Name:
- 5471-76-3
- Reference substance name:
- 2-butoxyethyl benzoate
- EC Number:
- 226-685-8
- EC Name:
- 2-butoxyethyl benzoate
- Cas Number:
- 5451-76-3
- Molecular formula:
- C13H18O3
- IUPAC Name:
- 2-butoxyethyl benzoate
- Test material form:
- other: variable coloured liquid
- Details on test material:
- - Name of test material (as cited in study report): Butyl Cellosolve™ Benzoate
- Physical state: variable coloured liquid
- Analytical purity: 99.86%
- Lot/batch No.: 02112012-JLT
- Expiration date of the lot/batch: 11 February 2013
- Storage condition of test material: Ambient (+18 to +36 ºC)
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Batch Manufactured and Supplied By: The Dow Chemical Company, Midland, MI, 48674, USA
Chemical Name : 2-Butoxy-ethanol benzoate
Physical Description (color + physical state): Variable coloured liquid
Purity : 99.86%
Lot No. : 02112012-JLT
pH : 6.08 (1% aqueous solution analyzed at Advinus under study no. G8567)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: inhouse bred (outbred)
- Age at study initiation: 7-8 months
- Weight at study initiation: 2.8 - 2.94 kg
- Housing: The rabbits were housed individually in rabbit cages (approx. size: L 65 x B 65 xH 45 cm) under standard laboratory conditions
- Diet (ad libitum): The animals were offered rabbit feed manufactured by Pranav Agro Industries Ltd, Sangli, Maharashtra, India.
- Water (ad libitum): The animals were provided deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier. The water was replenished once daily and the water bottles changed once a week.
- Acclimation period: 5-6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22°C
- Humidity (%): 56-65%
- Air changes (per hr): 12-15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A volume of 0.1 mL of the undiluted test substance was instilled into the eye of the rabbits.
- Duration of treatment / exposure:
- A volume of 0.1 mL of the test substance was placed in the everted lower lid (conjunctival sac) of the left eye of each of three rabbits. The eye lids were gently held together for about one second, in order to minimize loss of the test substance.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours post instillation.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: A volume of 0.1 mL of the test substance was placed in the everted lower lid (conjunctival sac) of the left eye of each of three rabbits. The eye lids were gently held together for about one second, in order to minimize loss of the test substance. The right eye of each rabbit remained untreated and served as the reference control.
SCORING SYSTEM: The eyes were evaluated with the illumination of a white light source at intervals of approximately 1, 24, 48 and 72 hours post instillation of the test substance according to the "Scale for Scoring Ocular Lesions" (Draize, 1944).
TOOL USED TO ASSESS SCORE: The fluorescein dye evaluation procedure was used for the treated eyes at 24 hours post instillation of the test substance to verify the extent or absence of corneal damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- RB9666
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- RB9666
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- RB9666
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- RB9666
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- RB9667
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- RB9667
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- RB9667
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- RB9667
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- RB9668
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- RB9668
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- RB9668
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- RB9668
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Eye Reactions:
There was no eye irritation (iritis, conjunctival irritation or corneal opacity) observed in any treated eye during the study at 1, 24, 48 and 72 hours post instillation.
After the completion of the study the animals were released for euthanasia and humanely euthanized. - Other effects:
- Clinical Observations:
There were no clinical signs of toxicity or mortality observed during the study.
Body Weights:
The body weights of all rabbits increased slightly throughout the observation period.
Any other information on results incl. tables
The individually determined mean irritation scores for each animal for corneal opacity, iris lesion, conjunctival redness and conjunctival chemosis for the 24-, 48- and 72-hour intervals are:
Animal No. (Sex) |
Corneal Opacity |
Iris Lesion |
Conjunctival Redness |
Conjunctival Chemosis |
RB9666 (M) |
0 |
0 |
0 |
0 |
RB9667 (M) |
0 |
0 |
0 |
0 |
RB9668 (M) |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, 2-butoxyethyl benzoate did not cause any eye irritation.
- Executive summary:
An acute eye irritation / corrosion study in rabbits was conducted to evaluate the eye irritation potential of 2-butoxyethyl benzoate. Under the conditions of this study, 2-butoxyethyl benzoate did not cause any eye irritation.
The test was performed in a stepwise manner. A single rabbit was initially exposed to the test substance. Since the test substance was not corrosive or severely irritating, the study was completed using two additional rabbits.
A quantity of 0.1 mL of the test substance was placed in the everted lower lid (conjunctival sac) of the left eye of each of three rabbits. The lids were gently held together for about one second, in order to minimize loss of the test substance. The right eye of each rabbit remained untreated and served as the reference control. The eyes were evaluated at 1, 24, 48 and 72 hours post instillation according to the scale for scoring ocular lesions (DRAIZE, 1944). There were no clinical signs of toxicity or mortality. All rabbits appeared healthy and gained body weight
throughout the observation period.
There was no eye irritation (iritis, conjunctival irritation or corneal opacity) observed in any treated eye during the study at 1, 24, 48 and 72 hours post instillation.
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