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EC number: 236-211-1 | CAS number: 13236-02-7
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 1,2,3-tris(2,3-epoxypropoxy)propane
- EC Number:
- 236-211-1
- EC Name:
- 1,2,3-tris(2,3-epoxypropoxy)propane
- Cas Number:
- 13236-02-7
- Molecular formula:
- C12H20O6
- IUPAC Name:
- 1,2,3-tris(2,3-epoxypropoxy)propane
- Reference substance name:
- N/A
- Cas Number:
- 178667-42-0
- Molecular formula:
- C12H24O8
- IUPAC Name:
- N/A
- Test material form:
- liquid
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung (CHL/IU)
- Details on mammalian cell type (if applicable):
- The Chinese Hamster Lung(CHL/IU) cell line was used. Modal chromosome number of CHL/IU cell line is 25 and doubling time is about 15 hours. The CHL/IU cell line has a high detection sensitivity, is commonly used in in vitro chromosomal aberration test and recommended in the regulatory guidelines.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- 2.6. Metabolic activation system
2.6.1. S9 fraction
Species : Rat
Sex : Male
Strain : Sprague-Dawley
Supplier : Molecular Toxicology, Inc.
Storage condition : Frozen(-20 °C below)
Product No. : 11-01L
Lot No. : 4504
Inductive material : Aroclor 1254-induced rat liver S-9
2.6.2. S9 cofactor
Name : Cofactor Ⅰ
Manufacturer : Genogen Co., Ltd.
Lot No. : 220330-I
Storage condition : Frozen(-70±20 °C)
2.6.3. Concentration of S9 Mix
Composition of S9 Mix mL (Final concentration)
S9 fraction 1 (10 % v/v S9)
Cofactor I 0.4 mol/L MgCl2 0.2 (8 μmol/mL)
1.65 mol/L KCl 0.2 (33 μmol/mL)
1.0 mol/L glucose-6-phosphate 0.05 (5 μmol/mL)
0.1 mol/L NADPH 0.4 (4 μmol/mL)
0.1 mol/L NADH 0.4 (4 μmol/mL)
0.2 mol/L sodium phosphate buffer(0.2 M SPB, pH7.4) 5.0 (100 μmol/mL)
Purified water 2.75 -
Total volume 10
S9 Mix was prepared by mixing the S9 fraction and cofactor, but mixing so that the concentration of S9 fraction is 10 %, and then was used while maintaining the refrigerated state(-1~10 °C). S9 Mix was treated with 0.5 mL/5 mL total volume/T-25 flask and used at a concentration of 1%(v/v) in the final medium. Enzyme activity was confirmed by chromosomal aberration of B[a]P. - Test concentrations with justification for top dose:
- Based on results in the concentration range finding study, highest concentration indicating 45±5 % RICC was selected as the highest concentration in all treatment series in the main study. It was serially diluted to consist of three concentration levels by the common ratio of 2. The prepared test substance was dissolved in the vehicle. The negative and positive control group were added. The positive control was treated at 5 μg/mL of B[a]P in the 6-hour treatment series in the presence of metabolic activation system. And, the positive control was treated at 0.2 μg/mL of 4NQO in the 6-hour treatment series and 24-hour treatment series in the absence of metabolic activation system. After preparing specimen from all treatment series, metaphase cells were checked to determine whether test substance induce genotoxicity. Concentrations in the main study are presented in the table below.
Series S9 Mix Concentration(μg/mL)
6+S + 27.5, 55, 110
6-S - 3.8, 7.5, 15
24-S - 2.5, 5, 10 - Vehicle / solvent:
- Sterile distilled water(SDW)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- benzo(a)pyrene
- Evaluation criteria:
- If the test substance meets all the following criteria, it was judged as positive, and if it does not meet all criteria, it was judged as negative.
- When at least one treatment group of test substance shows a statistically significant increase in the frequency of the metaphase cells with structural or numerical chromosomal aberration compared to the negative control group.
- When increases of frequency of metaphase cells with structural or numerical chromosomal aberration in the treatment group of test substance is concentration-related
- When at least one treatment group of test substance is outside the 95 % confidence range of the historical control data of the negative control group. - Statistics:
- Statistical analysis was performed by a chi-squared test using the SPSS program for the frequency of the metaphase cells(excluding gaps) with structural and numerical chromosomal aberration in the negative control group, treatment group of test substance and positive control group.
The result was judged to be significant when p<0.05
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- All validity criteria of this test were fulfilled.
In the all treatment series, there was a statistically significant increase of metaphase cells with structural chromosomal aberration when compared to the negative control group(p<0.05), and concentration-related increase was observed(p<0.05). Also, frequency of metaphase cells with structural chromosomal aberration was outside the 95 % confidence range of the historical negative control data.
In conclusion, the test substance, KF EPIOL-PE311(GPGE), was considered as inducing chromosomal aberration in the chinese hamster lung cells under the present study conditions.
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