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EC number: 203-745-1 | CAS number: 110-19-0
- 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
Endpoint summary
Administrative data
Description of key information
For isobutyl acetate, no valid data on irritation / corrosion could be located.
To compensate for this lack of data, information resulting from n-butyl acetate as supporting substance (structural analogue) are used as substitute.
No irritating effects in any of the rabbits tested could be observed in a primary skin irritation test similar to OECD TG 404.
In the rabbit eye, only slightly irritating effects were observed in a primary eye irritation test similar to OECD TG 405 and no classification is required.
There is no need to classify isobutyl acetate for respiratory irritation, based on data available for n-butyl acetate.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Was not conducted under GLP but has sufficient data for interpretation of results. Read-across hypothesis: for details please see read-across report in IUCLID section 13
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Diet: commercial available diet, ad libitum
- Water: municipal water, ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4-hour contact
- Observation period:
- up to 10 days after 4 hour contact period.
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- READING TIMES: 1 hour, 24 hour, and 2, 3, 7 and 10 days after 4 hour contact period.
SCORING SYSTEM: Method of Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable as no effect has been observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable as no effect has been observed
- Irritant / corrosive response data:
- none.
- Other effects:
- One animal was found dead at 10 days from unknown causes, but most probably not treatment-related.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study n-butyl acetate was not irritating to the skin of rabbits.
- Executive summary:
A 4 -hour occlusive treatment of 6 rabbits (3 males and 3 females) with 0.5 mL of the n-butyl acetate similar to OECD TG 404 did not induce any erythema nor edema, therefore the test item does not reveal any irritating potential under the conditions tested (DCC/BRRC, 1987).
This study was judged to be reliable (RL2) and therefore was selected as key study (read-across from supporting substance).
Reference
None.
Read-across justification: for details please see read-across report in IUCLID section 13
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- year of publication: 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles Read-across hypothesis: for details please see read-across report in IUCLID section 13
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single exposure (no washing indicated in report)
- Observation period (in vivo):
- up to 14 days
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- READING TIMES: 24, 48 and 72 h as well as 7 and if required 14 days after instillation of test material
SCORING SYSTEM: according to OECD TG 405 (Draize-Scores) - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 and #3 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effect observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2 and #4 each
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effect observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #1, #2, #3, and #4 each
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effect observed
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3 and #4 each
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- Corena score was 0 at any time for animal #1 and #3. For animals #2 and #4 cornea score was 1 at the 24 h reading but effects vanished thereafter. There were no iridial effects in all animals. At the 24, 48 and 72 h reading all animals showed some conjunctival redness (score 1), but this effect persistet only in animal #2 until the 7 days reading. No conjunctival redness was observed in animal #2 at the 14 days reading. Chemosis score was 0 throughout the experiment for animal #1. Animals #2, #3, and #4 showed some swelling (score 1) at the 24 hour reading but did not show any effects at the 48 h reading. Slight discharge was seen in 3 out of 4 animals at the 24 h reading, but not thereafter.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study N-Butyl Acetate was not irritating to the eyes.
- Executive summary:
New Zealand white rabbits were exposed to 0.1 mL of undiluted n-Butyl acetate and were observed for up to 14 days where necessary. Overall no iritis occurred and only barely perceptible effects were seen on the cornea (score:1) as well as the conjunctivae (redness score:1, chemosis score: 1), which were all reversible within a maximum of 14 days (ECETOC, 1998).
This study was judged to be reliable with restrictions (RL2) and therefore selected as key study (read-across from supporting substance).
Reference
Read-across justification: for details please see read-across report in IUCLID section 13
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
For isobutyl acetate, no valid studies concerning skin or eye irritation / corrosion or on respiratory irritation could be identified. There are only publications of low reliability (RL3 or 4) available.
To assess the skin, eye irritation / corrosion and respitatory irritation potential of isobutyl acetate, data for n-butyl acetate as supporting substance (structural analogue) will be used based on following reasons.
Isobutyl acetate is closely related to n-butyl acetate. Both compounds are only different in the terminal methyl group position of the butyl alcohol part of the molecule. Physical and chemical properties are only slightly influenced by this difference. Physical and chemical reactivity will basically be the same and only differ gradually. On this basis, local effects exerted from both substances are expected to be quite similar. Thus, it is justified to use n-butyl acetate as supporting substance in the evaluation of irritation / corrosion effects of isobutyl acetate. Further details on read-across justification can be found in the read-across documentation in section 13.
Skin irritation / corrosion
To assess the skin irritation / corrosion potential of isobutyl acetate, data originated from n-butyl acetate as supporting substance will be used.
DCC/BRRC 1987 (supporting substance n-butyl acetate)
N-Butyl Acetate was evaluated for dermal irritation in rabbits in a reliable study (RL2) which was selected as key study. A 4-hour occlusive treatment similar to OECD TG 404 with 0.5 mL of test item did not induce any erythema or edema. Therefore, the test item does not reveal any irritating potential under the conditions tested (DCC/BRRC, 1987).
Based on results from the supporting substance n-butyl acetate, isobutyl acetate can be assessed to be not irritating to the skin.
Eye irritation
To assess the eye irritation potential of isobutyl acetate, data originated from n-butyl acetate as supporting substance will be used.
ECETOC, 1998 (supporting substance n-butyl acetate)
In this GLP conform study according to OECD TG 405 New Zealandwhite rabbits were exposed to 0.1 mL of undiluted n-Butyl acetate (99% purity) and were observed for up to 14 days where necessary. Overall no iritis occurred and only barely perceptible effects were seen on the cornea (score:1) as well as the conjunctivae (redness score:1, chemosis score: 1), which were all reversible within a maximum of 14 days (ECETOC, 1998).
This study was judged to be reliable with restrictions (RL2).
DCC/BRRC 1987 (supporting substance n-butyl acetate)
Eye irritancy potential of n-butyl acetate was examined in a reliable study with rabbits (similar to OECD TG 405). No corneal injury in any of 6 eyes, iritis in 4 eyes at 1 and 4 hours after instillation, minor to moderate conjunctival irritation (redness and chemosis) in 6 eyes resulted from 0.1 mL of test substance (all healed at 48 hr). Mean scores (24, 48, and 72 h readings) over all 6 rabbit eyes were: cornea score = 0, iris score = 0.06, conjunctivae score = 0.33 and chemosis score = 0.06 (DCC/BRRC 1987).
Based on results from the supporting substance n-butyl acetate, isobutyl acetate can be assessed to be not irritating to the eye.
Respiratory irritation
To assess the respiratory irritation potential of isobutyl acetate, data originated from n-butyl acetate as supporting substance (structural analogue) will be used.
Iregren 1993 (supporting substance n-butyl acetate, cf. study record in section 7.10.3)
Iregren et al. (1993) tested the irritating potential of n-butyl acetate in nonsmoking volunteers in a series of three different chamber studies. The irritative effects were evaluated on the basis of the subjective feeling of irritation, clinical examination of eye irritation and the lung function. The first group of volunteers (Experiment I) was exposed to concentrations of 350, 700, 1050 and 1400 mg/m³ (72.5, 145, 220 and 290 ppm). Exposure lasted 20 minutes and was repeated four times in intervals of 24 h. Under these conditions, subjects reported irritation to the throat, difficulties in breathing and a sensation of a bad smell. There were trends towards increasing effects with increasing exposure level, although the observed effects were only weak and no significant differences in effect size between any of the exposure concentrations and the baseline level before exposure were observed.
In the second test (Experiment II), volunteers were exposed to 70 (“control” level) and 1400 mg/m³ n-butyl acetate (14.5 and 290 ppm) two times for 20 min at intervals of 7 h. In this test, ratings for irritation of all sites except skin, differed significantly between 290 ppm and the control, although the irritation was not felt to be severe. Accustoming to the bad smell occurred depending on exposure time and exposure level.
In the third part of the study, subjects were exposed to 70 and 700 mg/m³ n-butyl acetate (14.5 and 145 ppm) twice for 4 h within seven days. Significant differences in the extent of throat irritation, difficulties in breathing and sensation of a bad smell were reported, but no differences in ocular irritation were determined. Altogether, the authors of the study concluded a rather low irritating potential of n-butyl acetate.
The study is reliable with restrictions (RL2).
Nelson 1943 (supporting substance n-butyl acetate,cf. study record in section 7.10.3)
Ten volunteers were exposed to n-butyl acetate for 3 -5 minutes. The test persons themselves subjectively scored the extent of irritation (no reaction, slightly irritating, very irritating): The majority of the test persons reported irritation of the throat at 200 ppm (964 mg/m3) while irritation of the eyes and nose was reported by the majority of the test persons at 300 ppm (1446 mg/m3), which resulted in severe irritation of the throat.
In summary, the investigations with human volunteers indicate, that weak irritation of the eyes and respiratory tract occurs after short term inhalation exposure to concentrations of about 200 ppm. In one study throat irritation was already reported after 4 h exposure to 145 ppm.
Justification for selection of skin irritation / corrosion endpoint:
Adequate read-across study available of high reliability (Klimisch score 2)
Justification for selection of eye irritation endpoint:
Adequate read-across study of high reliability (Klimisch score 2, according to guideline and GLP)
Justification for classification or non-classification
For isobutyl acetate, no valid data on irritation / corrosion could be located.
To compensate for this lack of data, information resulting from n-butyl acetate as supporting substance are used as substitute (read-across from supporting substance (structural analogue or surrogate).
According to the negative findings in the key studies described above isobutyl acetate has not to be classified for irritation of the skin nor for irritation of the eyes according to the criteria set in the Regulation (EC) No. 1272/2008.
According to the results obtained for n-butyl acetate and described by Iregren (1993) it is concluded that there is no need to classify Isobutyl Acetate for respiratory irritation.
Due to the defatting solvent character of Isobutyl acetate it is assumed that frequent contact can lead to skin dryness of cracking of the skin. Therefore, it is proposed to classify Isobutyl acetate with EUH066 (Repeated exposure may cause skin dryness or cracking).
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