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EC number: 203-872-2 | CAS number: 111-46-6
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2,2'-oxydiethanol
- EC Number:
- 203-872-2
- EC Name:
- 2,2'-oxydiethanol
- Cas Number:
- 111-46-6
- Molecular formula:
- C4H10O3
- IUPAC Name:
- 2-(2-hydroxyethoxy)ethan-1-ol
Constituent 1
- Specific details on test material used for the study:
- Purity: 99.932 area %
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 26.9 g
- Housing: individual housing in appropriately labeled cages, Makrolon cages, type M I
- Bedding: Type Lignocel FS 14 fibres, dustfree bedding, supplied by SSNIFF, Soest, Germany
- Diet: standardized pelleted feed (Maus/Ratte Haltung "GLP", Provimi Kliba SA, Kaiseraugst, Switzerland), ad libitum
- Water: drinking water from bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fully air-conditioned rooms with central air conditioning
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- purified water
- Details on exposure:
- The substance to be administered per kg body weight was dissolved in purified water. To achieve a solution of the test substance in the vehicle, the test substance preparation was shaken thoroughly. All test substance formulations were prepared immediately before administration.
- Duration of treatment / exposure:
- once intraperitoneally
- Frequency of treatment:
- once intraperitoneally
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- vincristine sulfate
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- The animals were sacrificed and the bone marrow of the two femora was prepared 24 and 48 hours after administration from the animals of the highest dose group of 2000 mg/kg bw and those of the vehicle control group. In the test groups of 1000 mg/kg and 500 mg/kg bw and in the positive control groups, the 24-hour sacrifice interval was investigated only. After staining of the preparations, 2000 polychromatic erythrocytes were evaluated per animal and investigated for micronuclei. The normocytes with and without micronuclei occurring per 2000 polychromatic erythrocytes were also recorded.
As vehicle control, male mice were administered merely the vehicle purified water by the same route and in the same volume as the animals of the dose groups, which gave frequencies of micronucleated polychromatic erythrocytes within the historical vehicle control data range. - Evaluation criteria:
- A finding is considered positive if the following criteria are met:
• Statistically significant and dose-related increase in the number of PCEs containing micronuclei.
• The number of PCEs containing micronuclei has to exceed both the concurrent vehicle control value and the range of the historical vehicle control data.
A test substance is considered negative if the following criteria are met:
• The number of cells containing micronuclei in the dose groups is not statistically significant increased above the concurrent vehicle control value and is within the range of the historical vehicle control data. - Statistics:
- The statistical evaluation of the data was carried out using the program system MUKERN (BASF SE). The asymptotic U test according to MANN-WHITNEY (modified rank test according to WILCOXON) was carried out to clarify the question whether there are statistically significant differences between the untreated control group and the treated dose groups with regard to the micronucleus rate in polychromatic erythrocytes. The relative frequencies of cells containing micronuclei of each animal were used as a criterion for the rank determination for the U test. Statistical significances were identified as follows: * p ≤ 0.05 ** p ≤ 0.01. However, both biological relevance and statistical significance were considered together.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Both positive control substances, cyclophosphamide for clastogenicity and vincristine sulfate for spindle poison effects, led to the expected increase in the rate of polychromatic erythrocytes containing small or large micronuclei.
A slight inhibition of erythropoiesis determined from the ratio of polychromatic to normochromatic erythrocytes was detected at 2 000 mg/kg body weight at 48-hour sacrifice interval.
According to the results of the present study, the single intraperitoneal administration of Diethylene glycol did not lead to a relevant increase in the number of polychromatic erythrocytes containing either small or large micronuclei. The rate of micronuclei was close to the range of the concurrent vehicle control in all dose groups and at all sacrifice intervals and within the range of the historical vehicle control data.
Any other information on results incl. tables
Summary table - Induction of Micronuclei in bone marrow cells - single intraperitoneal administration
Test group |
Sacrifice |
Animal |
Micronuclei in PCE |
Number |
|
|
interval [hrs] |
No. |
totala |
large MNb |
of NCEc |
Vehicle control |
24 |
5 |
1.3 |
0.0 |
3 820 |
Test substance |
24 |
5 |
0.6 |
0.0 |
4 389 |
Test substance |
24 |
5 |
0.6 |
0.0 |
4 227 |
Test substance |
24 |
5 |
0.6 |
0.0 |
3 941 |
Positive control |
24 |
5 |
20.8** |
0.1 |
6 045 |
Positive control |
24 |
5 |
54.3** |
17.1** |
5 979 |
Vehicle control |
48 |
5 |
0.9 |
0.1 |
3 138 |
Test substance |
48 |
5 |
1.9 |
0.0 |
5 331 |
PCE |
= polychromatic erythrocytes |
NCE |
= normochromatic erythrocytes |
bw. |
= body weight |
|
|
a |
= sum of small and large micronuclei |
b |
= large micronuclei (indication for spindle poison effect) |
c |
= number of NCEs observed when scoring 10 000 PCEs |
|
|
* |
= p ≤ 0.05 |
** |
= p ≤ 0.01 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions chosen here, the test substance has no chromosome-damaging (clastogenic) effect nor does it lead to any impairment of chromosome distribution in the course of mitosis (aneugenic activity) in bone marrow cells of NMRI mice in vivo.
- Executive summary:
The test substance was assessed for its potential to induce chromosomal damage (clastogenicity) or spindle poison effects (aneugenic activitiy) in NMRI mice using the micronucleus test method. For this purpose, the test substance, dissolved in purified water, was administered once intraperitoneally to male animals at dose levels of 500 mg/kg, 1000 mg/kg and 2000 mg/kg body weight in a volume of 10 mL/kg body weight in each case.
The animals were sacrificed and the bone marrow of the two fermora was prepared 24 and 48 hours after administration in the highest dose group of 2000 mg/kg body weight and in the vehicle controls. In the test groups of 1000 mg/kg and 500 mg/kg body weight and in the positive control groups, the 24 -hour sacrifice interval was investigated only. After staining of the preparations, 2000 polychromatic erythrocytes were evaluated per animal and investigated for micronuclei. The normocytes with and without micronuclei occuring per 2000 polychromatic erythrocytes were also recorded.
As vehicle control, male mice were administered merely the vehicle purified water by the same route and in the same volume as the animals of the dose groups, which gave frequencies of micronucleated polychromatic erythrocytes within the historical vehicle control data range.
Both positive control substances, cyclophosphamide for clastogenicity and vincristine sulfate for spindle poison effects, led to the expected increase in the rate of polychromatic erythrocytes containing small or large micronuclei.
A slight inhibition of erythropoiesis determined from the ratio of polychromatic to normochromatic erythrocytes was detected at 2000 mg/kg body weight at 48 -hour sacrifice interval.
According to the results of the present study, the single intraperitoneal administration of the test substance did not lead to a relevant increase in the number of polychromatic erythrocytes containing either small or large micronuclei.
The rate of micronuclei was close to the range of the concurrent vehicle control in all dose groups and at all sacrifice intervals and within the range of the historical vehicle control data.
Thus, under the experimental conditions of this study, the test substance does not induce cytogenetic damage in bone marrow cells of NMRI mice in vivo.
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