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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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- June 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- As shown in the attached report, the suggested source chemicals , i.e. methylal and dioxolane, can be considered sufficient similar in relation to the toxicity super endpoint to the target chemicals, i.e. ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane and 2-ethylhexylal, to apply the read-across approach. Their structural similarity is also supported by a close similarity in terms of reactivity properties relevant for toxicity end points and in terms of physicochemical properties, although it was noted that 2-ethylhexylal shows some relevant physicochemical differences form the other acetals. Thus, it was concluded that the acetals are sufficiently similar to justify the experimental test results of the source chemicals to be read-across to target chemicals, although the 2-ethylhexylal predictions have to be considered of lower reliability than the other predictions because of its lower physicochemical similarity with the source chemicals.
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
- GLP compliance:
- no
Test material
- 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
- Details on test material:
- Source chemicals: methylal and dioxolane
Target chemicals: ethylal, propylal, butylal, TOU and 2-ethylhexylal
Constituent 1
Test animals
- Species:
- rat
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 195 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: Developmental toxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The available experimental toxicity data of methylal and dioxolane were used for the read-across prediction of the prenatal developmental toxicity of the targets ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane and 2-ethylhexylal. The following predictions were obtained for the prenatal developmental studies of propylal, TOU, 2-ethylhexylal and butylal: NOAEL (dev) of 195 mg/kg/bw/d and NOAEL (mat) of 250 mg/kg/bw/d.
These results were further confirmed by the QSAR model predictions for structural dysmorphogensis developmental toxicity on rabbit, rat, rodent and mouse for ethylal, butylal, 2,5,7,10-tetraoxaundecane, 2-ethylhexylal, which resulted to be NEGATIVE, although the reliability of the QSAR predictions was often little because the chemical class of the acetals is poorly represented in the employed Leadscope model. - Executive summary:
Prenatal developmental toxicity study
Source chemicals: methylal and dioxolane
Target chemical(s): ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane and 2-ethylhexylal
Read-across predictions: NOAEL (dev) of 195 mg/kg/bw/d and NOAEL (mat) of 250 mg/kg/bw/d for propylal, TOU, 2-ethylhexylal and butylal.
NOAEL (dev) of 31814.88.3mg/m3 and NOAEL (mat) of 6174.64 mg/m3for ethylal.
In the current read-across analysis, the available experimental toxicity data of methylal and dioxolane were used for the read-across prediction of the prenatal developmental toxicity of the targets ethylal, propylal, butylal, 2,5,7,10-tetraoxaundecane and 2-ethylhexylal. The available developmental toxicity data were further analysed by the commissioner and it was highlighted that in the methylal inhalation study, NOEL (dev) and NOAEL (dev) can be considered equal (as the NOEL is the highest tested dose and no effect is observed in the test). Thus, in this study, NOAEL (dev) was considered as 31814.77 mg/m3.
In addition, in the dioxolane study, the NOAEL are defined by oral route and the adverse effect is a reduced ossification of the foetus. This kind of adverse effect is not observed with methylal. Thus, since the oral route is relevant for propylal, TOU, 2-ethylhexylal and butylal and the inhalation route is relevant for ethylal, the dioxolane data were read-across to propylal, butylal, 2,5,7,10-tetraoxaundecane and 2-ethylhexylal, while the methylal data were read-across to ethylal.
Thus, the following predictions were obtained for the prenatal developmental studies of propylal, TOU, 2-ethylhexylal and butylal: NOAEL (dev) of 195 mg/kg/bw/d, obtained as mean value of dioxolane NOAEL (dev) data, and NOAEL (mat) of 250 mg/kg/bw/d. The prediction for 2-ethylhexylal acute has to be considered of lower reliability than the other predictions because of its lower similarity with the source chemicals.
While, the following predictions were obtained for the prenatal developmental studies of ethylal: NOAEL (dev) of 31814.88.3mg/m3 and NOAEL (mat) of 6174.64 mg/m3.
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