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Diss Factsheets
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EC number: 203-561-1 | CAS number: 108-21-4
- 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For read across justification see the attachment in the read across object attached to chapter 7.4.1 (skin sensitisation).
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This experiment was carried out to quantify the irritancy of the similar acetate ester, ethyl acetate. Secondary source but one that is considered highly reliable since data (generated to guideline) has undergone a peer review process before inclusion and key experimental results are available. Data used in this source has been subject to a peer review process by a reputable body.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- Source indicates data generated to GLP, but no indication of test laboratory.
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- single instillation, as per guideline
- Observation period (in vivo):
- no data
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.41
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.08
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 1.25
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.58
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.17
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 15
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: See notes below
- Irritant / corrosive response data:
- Overall irritation score = (Corneal Opacity+area)x5 + Irisx5 + (Conjunctival redness + chemosis + discharge)x2. Maximum possible = 110.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of these results, the substance does not warrant irritation under either the DSD or EU GHS regulation.
- Executive summary:
In a reliable secondary source, which reported the results from peer reviewed guideline studies, ethyl acetate was found to be only midly irritating to rabbit eyes, with all effects disappearing within 7 days.
Synopsis
Based on these results, ethyl acetate would not be classified as irritating under the EU GHS regulation.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This experiment was carried out to quantify the irritancy of the similar acetate ester, n-butyl acetate. Secondary source but one that is considered highly reliable since data (generated to guideline) has undergone a peer review process before inclusion and key experimental results are available. Data used in this source has been subject to a peer review process by a reputable body.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- Source indicates data generated to GLP, but no indication of test laboratory.
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- single instillation, as per guideline
- Observation period (in vivo):
- no data
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.08
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: one animal showed a rating of 1 at 7 days.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 7.5
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: See notes below
- Irritant / corrosive response data:
- Overall irritation score = (Corneal Opacity+area)x5 + Irisx5 + (Conjunctival redness + chemosis + discharge)x2. Maximum possible = 110.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of these results, the substance does not warrant irritation under either the DSD or EU GHS regulation.
- Executive summary:
In a reliable secondary source, which reported the results from peer reviewed guideline studies, n-butyl acetate was found to be only midly irritating to rabbit eyes, with all effects disappearing within 14 days (most within 7).
Synopsis
Based on these results, n-butyl acetate would not be classified as irritating under the EU GHS regulation.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1961
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The eye irritation potential was examined by depositing 0.5 ml test material in the eye of albino rabbits. Eighteen to twenty four hours later the eyes are reexamined without and then with fluorescein administration in the eye.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- No additional information available.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml of test material was applied
- Duration of treatment / exposure:
- 18 to 24 hours
- Observation period (in vivo):
- After 18-24 hours, the eyes are examined for irritation and then fluorescein is administered and the eyes are reexamined.
- Number of animals or in vitro replicates:
- 5
- Details on study design:
- Prior to treatment with test material, the eyes of albino rabbits were examined with 5% fluorescein solution to ensure the eyes used for the test are normal. The eyes were washed with water approximately 20 seconds later. After approximately a two hour interval, 0.5 ml test material was applied to five eyes and examined after 18 -24 hours. The eyes were examined in strong diffuse daylight, then stained with fluorescein and the injury scored.
- Irritant / corrosive response data:
- Instillation of 0.5 ml test material in 5 rabbit eyes caused some diffuse necrosis of corneal cells which healed quickly.
- Other effects:
- No additional information available.
- Conclusions:
- Instillation of 0.5 ml test material in 5 rabbit eyes caused some diffuse necrosis of corneal cells which healed quickly. No definitive conclusions concerning classification can be drawn from this study as 0.5 ml of test material have been used, while the guideline requires 0.1 ml.
- Executive summary:
The eye irritation potential of propyl acetate was examined. Instillation of 0.5 ml test material in 5 rabbit eyes caused some diffuse necrosis of corneal cells which healed quickly. No definitive conclusions concerning classification can be drawn from this study as 0.5 ml of test material have been used, while the guideline requires 0.1 ml.
Instillation of 0.5 ml test material in 5 rabbit eyes caused some diffuse necrosis of corneal cells which healed quickly.
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See attached justification below.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Remarks on result:
- no indication of skin sensitisation
Data source
Materials and methods
Test material
- Reference substance name:
- Isopropyl acetate
- EC Number:
- 203-561-1
- EC Name:
- Isopropyl acetate
- Cas Number:
- 108-21-4
- Molecular formula:
- C5H10O2
- IUPAC Name:
- isopropyl acetate
- Details on test material:
- - Name of test material (as cited in study report): isopropyl acetate
Constituent 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 7.5 - < 15
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 0.33 - < 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average results of 2 worst animals reported as per CLP criteria
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 0.17
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average results of 2 worst animals reported as per CLP criteria
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 1 - < 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: average results of 2 worst animals reported as per CLP criteria
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 0.33 - < 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average results of 2 worst animals reported as per CLP criteria
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.