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Diss Factsheets
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EC number: 224-631-8 | CAS number: 4431-83-8
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- other: read accross
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read accross following OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Joint meeting of the chemicals committee and the working party on chemical, pesticides and biotechnology, Guidance on grouping of chemicals, ENV/JM/MONO(2007)28
- Principles of method if other than guideline:
- Read Accross tools: the main tool recommended in the regulatory context is the OECD (Q)SAR Application Toolbox (Guidance document for using the OECD (Q)SAR Application Toolbox to develop chemical categories according to the OECD Guidance on Grouping of Chemicals, ENV/JM/MONO(2009)5 and ACD/Pyschem Suite version 12.0 were used for the calculation of several physico chemical properties, i.e. density, surface tension, water solubility, LogPow, needed to compare the physico chemical properties of the source chemicals and the target ones.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Dimethoxymethane
- EC Number:
- 203-714-2
- EC Name:
- Dimethoxymethane
- Cas Number:
- 109-87-5
- Molecular formula:
- C3H8O2
- IUPAC Name:
- dimethoxymethane
- Reference substance name:
- 1,3-dioxolane
- EC Number:
- 211-463-5
- EC Name:
- 1,3-dioxolane
- Cas Number:
- 646-06-0
- Molecular formula:
- C3H6O2
- IUPAC Name:
- 1,3-dioxolane
Constituent 1
Constituent 2
Results and discussion
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 3 127.89 mg/m³ air
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: weighted mean mathematical formalism
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The read-across analysis was performed for the toxicity super endpoint, including five endpoints, i.e. acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, subchronic inhalation toxicity (90 days, rat) and prenatal developmental toxicity study, that were treated with the same reasoning in terms of mechanism action and for which the read-across follow a similar justification.
In the current study, methylal and dioxolane were selected by the commissioner as source chemicals or analogs, to predict the same endpoints for the target chemicals, i.e. ethylal, 2,5,7,10-tetraoxaundecane, 2-ethylhexylal, propylal, butylal, however, in the case experimental toxicity data of ethylal, 2,5,7,10-tetraoxaundecane, 2-ethylhexylal, propylal, butylal were already available from the commissioner for some of the toxicity endpoints, these data were also employed for the read-across predictions of the remaining target chemicals. Thus, depending on the availability of their experimental toxicity data, the five acetals (ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane, 2-ethylhexylal) were employed as source chemicals or target chemicals.
A many-to-many read-across was performed since the endpoint information for many chemicals, methylal and dioxolane, was used to estimate the same toxicity endpoints for the target chemicals, i.e. ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane and 2-ethylhexylal, which were considered to be “similar” enough according to their structural, mechanistic and physicochemical/reactivity property profiles to justify the read-across approach. Figure 4 (see full report attached below) shows an example of a many-to-many read-across approach.
Applicant's summary and conclusion
- Conclusions:
- The subchronic inhalation toxicity of the target 2,5,7,10-Tetraoxaundecane provided by the weighted mean mathematical formalism is a NOAEC (13-week) = 3127.89 mg/m3
- Executive summary:
The read-across analysis was performed for the toxicity super endpoint, including five endpoints, i.e. acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, subchronic inhalation toxicity (90 days, rat) and prenatal developmental toxicity study, that were treated with the same reasoning in terms of mechanism action and for which the read-across follow a similar justification.
In the current study, methylal and dioxolane were selected by the commissioner as source chemicals or analogs, to predict the same endpoints for the target chemicals, i.e. ethylal, 2,5,7,10-tetraoxaundecane, 2-ethylhexylal, propylal, butylal, however, in the case experimental toxicity data of ethylal, 2,5,7,10-tetraoxaundecane, 2-ethylhexylal, propylal, butylal were already available from the commissioner for some of the toxicity endpoints, these data were also employed for the read-across predictions of the remaining target chemicals. Thus, depending on the availability of their experimental toxicity data, the five acetals (ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane, 2-ethylhexylal) were employed as source chemicals or target chemicals.
A many-to-many read-across was performed since the endpoint information for many chemicals, methylal and dioxolane, was used to estimate the same toxicity endpoints for the target chemicals, i.e. ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane and 2-ethylhexylal, which were considered to be “similar” enough according to their structural, mechanistic and physicochemical/reactivity property profiles to justify the read-across approach. Figure 4 (see full report attached below) shows an example of a many-to-many read-across approach.
Subchronic inhalation toxicity
Source chemicals: methylal and dioxolane
Target chemical(s): ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane and 2-ethylhexylal
Read-across predictions: NOAEC (13-week) = 3127.89 mg/m3
In the current read-across analysis, the available experimental toxicity data of methylal and dioxolane were used for the read-across prediction of the subchronic inhalation toxicity of the targets ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane and 2-ethylhexylal. The available data refer to two different measurements, the NOEL, which is the no observed effect level, and the NOAEC, which is the no observed adverse effect concentration.
The commissioner analysed in more details the study reports of the two source substances. For methylal, no NOAEC is defined in the report but a NOAEC value could be defined at 6300 mg/m3 as a worst case value (=NOEL value). Thus, the read-across prediction was performed employing the NOAEC values of 6300 mg/m3 for methylal and of 903 mg/m3 for dioxolane. It has to be taken into account that the determination of the NOAEC is highly toxicological evaluation-dependent, since the determination of an adverse effect is not as theoretical as the determination of an LC50 in an acute toxicity test. Tests are available for methylal and dioxolane and have been performed by different labs with different sensitivity to define an adverse effect which is the basis of the NOAEC. This difference of sensitivity could explain the disparity between NOAEC of methylal and dioxolane.
Since inhalation toxicity is strongly influenced by the vapor pressure, the experimental inhalation toxicity data of the source methylal was weighted less than the one of dioxolane, because of its much higher vapor pressure than the targets.
The subchronic inhalation toxicity of the targets ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane and 2-ethylhexylal would be predicted of NOAEC (13-week) = 903 mg/m3 in the worst case scenario. However, a more consistent prediction is considered the one provided by the weighted mean mathematical formalism which led to prediction of NOAEC (13-week) = 3127.89 mg/m3.
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