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Diss Factsheets
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EC number: 906-256-8 | CAS number: -
- 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 DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented, acceptable study report
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
- Reference Type:
- publication
- Title:
- Opinion on Diethylene Glycol
- Author:
- SC on consumer products (SCCP)
- Year:
- 2 008
- Bibliographic source:
- http://ec.europa.eu/health/ph risk/risk en.htm
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 479 (Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of assay:
- sister chromatid exchange assay in mammalian cells
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Briefly, the test chemical was analyzed by the sponsor and found to consist of 99.3% diethylene glycol, 0.09% monoethylene glycol, 0.39% triethylene
glycol, 0.19% unknown impurities and 0.03% water. The test chemical was added directly into the cell culture medium of the test system without dilution . No analyses of stability or concentration in the medium were performed. Diethylene glycol is infinitely soluble in water and no solvent incompatibilities were listed by the sponsor.
Method
- Target gene:
- CHO cells
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S-9 mix
- Test concentrations with justification for top dose:
- 30 - 50 mg/ml
- Vehicle / solvent:
- Cell-culture medium was used as the solvent as the test material was added directly into the cell-culture test system.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: cyclophosphamide and triethylenemelamíne
- Details on test system and experimental conditions:
- Selection of Test Concentrations: Preliminary experiments were performed with CHO cells to determine an appropriate range of test concentrations in which the highest concentration would kill, no more than (approximately) 90% of the treated cells. Test concentrations for the SCE test were chosen so that sufficient numbers of cells in the second division (M2) would be available for determination of SCEs. Test results with diethylene glycol indicated that concentrations up to 50 mg/ml, the maximum concentration used for evaluation of test chemicals following the BRRC standard test protocol, were not cytotoxic to CHO cells. For the definitive tests, 50 mg/ml was also selected as the maximum dose and additional concentrations below this dose were evaluated. In this tests, doses between 30 and 50 mg/ml were evaluated for genotoxic potential.
Control Agents: Positive and solvent control materials were tested concurrently with the test sample to assure both the sensitivity of the test systems and the concurrence of the results to historical test performance at BRRC. For this assays, dimethylnitrosamine (DMN)-CAS 62-75-9 and ethylmethanesulfonate (EMS)-CAS 62-50-0 were used as positive control agents to assure the sensitivity and reliability of the test system for detecting metabolic activation dependent and independent mutagens, respectively. Cell culture medium was used as the negative control.
Metabolic Activation: S9 liver homogenate, prepared from Aroclor 1254-induced, Sprague-Dawley male rats, was purchased- from Microbiological Associates, Bethesda, MD. The S9 preparation used for the CHO test was screened for appropriate metabolic activity by the supplier with three activation-dependent mutagens and Salmonella strains TA98 and TA100. A volume of 50 ul of S9 homogenate was used for each 1.0 ml of the S9 activation mixture. - Evaluation criteria:
- For evaluations of direct clastogenic potential, CHO cells were exposed to diethylene glycol and appropriate controls for the complete 12 hour period without S9 activation. Determination of indirect genotoxic potential, requiring metabolic activation by liver S9-homogenate, was studied with a 2-hour exposure period to the test chemical and S9 activation system.
- Statistics:
- Statistical analyses of the test data employed the Fisher's Exact Test (one-tailed) to determine significance of differences between the test and control populations. This statistical test was considered appropriate for the analysis of the data because it is a distribution independent test and cytogenic data often vary from a normal distribution required for parametric analyses. A positive test result was interpreted by the attainment of differences from the control at the p < 0.05 level of significance for at least one test concentration, together with an indication of a concentration-related effect of exposures or
reproducibility between the duplicate cultures. Rounding of data to either two decimal places or to the appropriate number significant figures was performed for presentation on tables. Although statistically significant decreases in genotoxicity indices can occur because of cytotoxic responses, only statistically significant increases ín responses above control values are indicated on tables for simplicity. All statistical tests were performed to determine whether the treatment with the test agent produced a response statistically different from the value(s) obtained with the concurrent solvent control cultures.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: > 50 mg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Diethylene glycol did not produce dose-related, statistically significant increases in the incidence of chromosome aberrations in CHO cells in tests conducted with and without the addition of a rat-liver homogenate, S9 metabolic activation system. A single statistical indication of an increase above control values was obtained for the lowest dose sampled at 12 hr after test initiation in the test with S9 activation. This result was not repeated at higher doses and the level of the increase was essentially the same as the variation in the concurrent negative control values. For these reasons, the statistical indication was not considered biologically relevant. The positive control agents, cyclophosphamide and triethylenemelamine, both produced significant increases in chromosome aberrations indicative of the appropriate, reliability of the test system. The control cultures employing only the culture growth medium had low and acceptable levels of chromosome aberrations typical for these cultured cells. Diethylene glycol was concluded to lack significant genotoxic activity under the conditions employed for this in vitro test system.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No statistically significant increase in the number of SCEs was observed with any of the test cultures treated with the test agent. The incidence of SCEs in all of the cultures exposed to the test agent was within the historical negative control range for this test at BRRC (Methods, Section G1). Diethylene glycol was considered inactive under the non-activation conditions of this sensitive in vitro assay.
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