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EC number: 209-963-3 | CAS number: 599-04-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific principles with acceptable deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- ; only 4 bacterial strains were used for testing (5 are recommended)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- α-hydroxy-β,β-dimethyl-γ-butyrolactone
- EC Number:
- 209-963-3
- EC Name:
- α-hydroxy-β,β-dimethyl-γ-butyrolactone
- Cas Number:
- 599-04-2
- Molecular formula:
- C6H10O3
- IUPAC Name:
- (3R)-3-hydroxy-4,4-dimethyloxolan-2-one
- Details on test material:
- - Name of test material (as cited in study report): D-Pentolacton kristallin
- Analytical purity: >99 %
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- Determination of the rate of induced back mutations of several bacteria mutants from histidine auxotrophy (his-) to histidine prototrophy (his+).
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from the liver of male Sprague-Dawley rats (treated with a single dose of 500 mg/kg bw Aroclor 1254 five days before sacrifice) and mixed with a series of cofactors (MgCl2, KCl, glucose-6-phosphate, NADP, phosphate buffer pH 7.4).
- Test concentrations with justification for top dose:
- 0, 20, 100, 500, 2500 and 5000 µg per plate, in standard plate test and preincubation test, with and without S9-mix
- Vehicle / solvent:
- Aqua dest.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see "Deatils on test system and conditions"
- Details on test system and experimental conditions:
- Standard plate test:
The experimental procedure is based on the method of Ames et al.
Test tubes containing 2 ml portions of soft agar which consists of 100 ml agar (0.6% agar + 0.6% NaCl) and 10 ml amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM histidine + 0.5 mM biotin) are kept in a water bath at 45 °C, and the remaining components are added in the following order:
0.1 ml test solution
0.1 ml bacterial suspension
0.5 ml S-9 mix (in tests with metabolic activation)
or
0.5 ml phosphate buffer (in tests without metabolic activation)
After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within approx. 30 seconds.
Preincubation test:
The experimental procedure is based on the method described by Yahagi et al. and Matsushima et al.
0.1 ml test solution, 0.1 ml bacterial suspension and 0.5 ml S-9 mix are incubated at 37 °C for the duration of 20 minutes. Subsequently, 2 ml of soft agar is added and, after mixing, the samples are poured onto the Vogel-Bonner agar plates within approx. 30 seconds.
Composition of the minimal glucose agar:
980 ml aqua dest.
20 ml Vogel-Bonner E medium
15 g Difco bacto agar
20 g D-glucose, monohydrate.
After incubation at 37 °C for 48 hours in the dark, the bacterial colonies (his+ revertants) are counted.
Controls:
- Negative control:
Parallel with each experiment with and without S-9 mix, a negative control (solvent control, sterility control) is carried out for each tester strain in order to determine the spontaneous mutation rate.
- Positive controls:
The following positive control substances are used to check the mutability of the bacteria and the activity of the S-9 mix:
with S-9 mix: 10 µg 2-aminoanthracene (dissolved in DMSO) for the strains TA 100, TA 98, TA 1537 and TA 1535
without S-9 mix: 5 µg N-methyl-N´-nitro-N-nitrosoguanidine (MNNG), (dissolved in DMSO) for the strains TA 100 and TA 1535 and 10 µg 4-nitro-o-phenylendiamine (dissolved in DMSO) for the strain TA 98; 100 µg 9-aminoacridine chloride monohydrate (dissolved in DMSO) for the strain TA 1537. - Evaluation criteria:
- In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No increase in the number of his revertants was seen in the standard plate test and in the preincubation test, with or without the addition of S9-mix.
No bacteriotoxic effect (reduced his background growth) was observed. The test material was completely soluble in aqua dest. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Maximum revertants/plate and corresponding test concentrations in the standard plate test: |
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|
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Strain |
Tested compound |
Maximum revertants/plate [corresponding dose unit in µg/plate] |
|
|
|
without S9-mix |
with S9-mix |
S. typhimurium TA1535 |
Aqua dest |
16 ± 4 |
13 ± 1 |
Test substance |
24 ± 5 [5000] |
21 ± 1 [20] |
|
Positive Control |
1927 ± 64 |
114 ± 17 |
|
S. typhimurium TA100 |
Aqua dest |
105 ± 6 |
112 ± 13 |
Test substance |
118 ± 21 [20] |
126 ± 13 [500] |
|
Positive Control |
2083 ± 161 |
1913 ± 42 |
|
S. typhimurium TA1537 |
Aqua dest |
8 ± 3 |
12 ± 2 |
Test substance |
12 ± 6 [500] |
17 ± 3 [500] |
|
Positive Control |
527 ± 34 |
185 ± 19 |
|
S. typhimurium TA98 |
Aqua dest |
30 ± 3 |
44 ± 1 |
Test substance |
38 ± 6 [2500] |
57 ± 11 [100] |
|
Positive Control |
815 ± 19 |
1447 ± 160 |
|
Table 2: Maximum revertants/plate and corresponding test concentrations in the preincubation test: |
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|
|||
Strain |
Tested compound |
Maximum revertants/plate [corresponding dose unit in µg/plate] |
|
|
|
without S9-mix |
with S9-mix |
S. typhimurium TA1535 |
Aqua dest |
12 ± 2 |
13 ± 1 |
Test substance |
19 ± 1 [2500] |
14 ± 4 [500] |
|
Positive Control |
1024 ± 29 |
142 ± 2 |
|
S. typhimurium TA100 |
Aqua dest |
104 ± 7 |
118 ± 4 |
Test substance |
123 ± 3 [20] |
132 ± 19 [100] |
|
Positive Control |
1203 ± 45 |
1260 ± 70 |
|
S. typhimurium TA1537 |
Aqua dest |
8 ± 1 |
12 ± 1 |
Test substance |
11 ± 9 [2500] |
12 ± 2 [100] |
|
Positive Control |
495 ± 161 |
162 ± 9 |
|
S. typhimurium TA98 |
Aqua dest |
26 ± 6 |
42 ± 3 |
Test substance |
37 ± 5 [5000] |
48 ± 11 [500] |
|
Positive Control |
1034 ± 106 |
995 ± 205 |
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.
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