Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 14 AUG 1989 to 08 SEP 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-study, comparable to guideline study with acceptable restrictions (no information on test substance).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : no information on test substance
- Principles of method if other than guideline:
- No guideline stated but study according to Ames et al. (1975), Mutat. Res. 31, 347-364
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Isobutyl acetate
- EC Number:
- 203-745-1
- EC Name:
- Isobutyl acetate
- Cas Number:
- 110-19-0
- Molecular formula:
- C6H12O2
- IUPAC Name:
- isobutyl acetate
- Details on test material:
- - Name of test material (as cited in study report): C-01360; isobutyl acetate, urethane grade
- Physical state: clear colourless liquid
- Analytical purity: no data ( but as iso-butyl acetate is usually available as high quality / purity, it can probably be assumed that test item purity was high)
- Purity test date: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Additional strain / cell type characteristics:
- other: all strains: rfa - cell wall deficiency, uvrB - deficient DNA excision-repair system, strains TA98 and TA100: presence of pKM101 plasmid (carriing r-factor) - increased sensitivity to some mutagens
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix from the livers of Aroclor 1254 induced (500 mg/kg) male Sprague-Dawley rats.
- Test concentrations with justification for top dose:
- 0, 100, 333, 1000, 3333 and 10000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with S-9 mix: 2-aminoanthracene; without S-9 mix: 2-nitrofluorene (TA98, TA1538), sodium azide (TA100, TA1535), ICR-191 (TA1537)
- Remarks:
- S-9 preparations were tested for metabolic activity with 7,12-Dimethylbenzanthracene and 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
- Expression time (cells in growth medium): 48 h
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; toxicity was determined in a preceding-range finding test with tester strain TA100.
OTHER: The integrity of tester strains was checked by testing for rfa wall mutation (sensivity to crystal violet) and for pKM101 plamid r-factor (resistance to ampicillin). - Evaluation criteria:
- - To be evaluated as positive, a test substance must cause at least a doubling in the mean revertants per plate of at least one tester strain.
- This increase in the mean number of revertants per plate must be accompanied by a dose response to increasing concentrations of the test substance.
- If the study is to be judged positive solely on the basis of a dose-responsive, less than 3-fold increase on TA1537 or TA1538, the response must be confirmed in a repeat experiment.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- In the range finding test, no cytotoxicity was observed in tester strain TA100 up to the highest concentration tested (10000µg/plate).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
- A range-finding test was performed using tester strain TA100 and 10 evenly spaced test substance concentrations between 10 and 10,000 µg/plate.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- In the range-finding test, cytotoxicity was examined. No cytotoxicity was observed up to the highest test substance concentration of 10,000 µg/plate. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 7.6.1: Gene mutation assay (plate incorporation) results |
||||||
Concentration [µg/plate] |
S9 |
Revertants/plate [mean of 3 plates] |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 1538 |
||
DMSO |
– |
10 |
94 |
12 |
4 |
5 |
100 |
– |
13 |
95 |
8 |
6 |
5 |
333 |
– |
11 |
101 |
11 |
6 |
5 |
1000 |
– |
11 |
99 |
10 |
6 |
5 |
3333 |
– |
10 |
89 |
4 |
4 |
5 |
10000 |
– |
11 |
102 |
11 |
5 |
5 |
Pos. control |
– |
211 |
673 |
412 |
123 |
351 |
DMSO |
+ |
20 |
106 |
7 |
6 |
10 |
100 |
+ |
19 |
116 |
8 |
8 |
13 |
333 |
+ |
23 |
117 |
12 |
7 |
15 |
1000 |
+ |
16 |
112 |
11 |
6 |
14 |
3333 |
+ |
17 |
104 |
13 |
6 |
14 |
10000 |
+ |
17 |
117 |
10 |
6 |
12 |
Pos. control |
+ |
285 |
500 |
46 |
36 |
400 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In a reverse gene mutation assay according to Ames, isobutyl acetate was not mutagenic as it did not show any positive response (increasein the number of revertants of S. typhimurium) with any of the tester strains used either in the presence or absence of microsomal enzymes. - Executive summary:
In a reverse gene mutation assay in bacteria according to Ames (1975), strains of S. typhimurium (TA 98, TA 100, TA 1535, TA 1537, TA 1538) were exposed to isobutyl acetate at concentrations of 0, 100, 333, 1000, 3333, and 10000 µg/plate in the presence and absence of mammalian metabolic activation (S-9 mix from Aroclor 1254 induced rat liver) in a plate incorporation test.
Isobutyl acetate was tested up to the limit concentration of 10000 µg/plate. No toxicity or precipitation was observed. The positive controls induced the appropriate responses in the corresponding strains. Isobutyl acetate did not increase the number of revertants in any of the test strains. There was no evidence of induced mutant colonies over background. Isobutyl acetate was negative under test conditions.
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.