Registration Dossier
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EC number: 219-909-0 | CAS number: 2568-90-3
- 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

Endpoint summary
Administrative data
Description of key information
Final report of test performed according to OECD 408 and GLP will be available on 28 February 2020. Preliminary test is available and provided.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read accross following OECD guidelines
- 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:
- In the read-across technique, the endpoint information for one chemical is used to predict the same endpoint
for another chemical, which is considered “similar” in some way (usually based on structural similarity). The
chemical being used to make an estimate is commonly referred to as a source chemical, or analogue
whereas a chemical for which the endpoint is being estimated is referred to as a target chemical. In the
current study, the endpoint information of Methylal, selected by the commissioner as source chemical or
analogue, was used to predict the same endpoints for the target substances Ethylal and Butylal, which were
considered to be similar to Methylal on the basis of structural and mechanistic similarity. The read-across
study was performed according to the guidance document on the grouping of chemicals (including readacross
and chemical categories)1. According to the guideline, the regulatory acceptance of a read-across
analysis requires the analysis to be supported by a detailed documentation to be provided according to the
defined read-across reporting formats2,3. The main elements of the read-across reporting format are the
following:
a) Hypothesis for the analogue approach. Description of the molecular structure a chemical must
have to be suitable as a source chemical. All functional groups need to be identified. Provide the
hypothesis for why the read-across can be performed. If there is a mechanistic reasoning to the readacross,
describe the foreseen mode of action for source and target chemicals.
b) Source chemical(s). Description the source chemical(s) as comprehensively as possible. Provide
CAS numbers, names and chemical structures of the source chemical(s).
c) Analogue approach justification. Based on available data, including basic physicochemical
properties, it has to be summarised how these results verify that the read-across is justified. The data
should also show that functional groups not common to source and target chemicals do not affect the
anticipated toxicity.
d) Data matrix. A matrix of data (endpoints vs. target and source chemical(s)) has to be provided. - GLP compliance:
- no
- Limit test:
- no
- Dose descriptor:
- NOAEC
- Effect level:
- 6 300 mg/m³ air
- Based on:
- test mat.
- Sex:
- not specified
- Critical effects observed:
- not specified
- Conclusions:
- Source chemical: Methylal
Target chemicals: Ethylal, Butylal
Read-across predictions: NOAEC (13-week) = 6300 mg/m3 - Executive summary:
Source chemical: Methylal
Target chemicals: Ethylal, Butylal
Read-across predictions: NOAEC (13-week) = 6300 mg/m3
Experimental data for subchronic inhalation toxicity are available for the source compound Methylal based on
a OECD 413 study conducted in rat under 90-days exposure period (GLP study). 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 report of the
source substance 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). 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.
In the current read-across analysis, the available experimental toxicity data of Methylal (i.e., NOAEC value
of 6300 mg/m3) was used for the read-across prediction of the sub-chronic inhalation toxicity of the target
compounds Ethylal and Butylal. However, since inhalation toxicity is strongly influenced by the vapor
pressure, the experimental inhalation toxicity data of the source Methylal is expected to be higher than the
inhalation toxicity of Ethylal Butylal because of their lower volatility with respect to the source Methylal.
Therefore, it was concluded that for the target compounds Ethylal and Butylal the read-across approach
provided a conservative sub-chronic inhalation toxicity prediction of NOAEC = 6300 mg/m3.
Reference
Please refer to attached full study report for details of analogue approach (structural similarity, mechanistic reasonning, toxicity profiling), of source chemical, justification of the approach (undelying rationale, comparison of physchem and molecular properties) and data matrix.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 6 300 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Endpoint derived by read-across (Klimisch code 2) from an OECD TG 413 (GLP) study with methylal (Hofmann, 1994). RSS of the source test report is provided. RSS of the source subtance is provided.
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
DNEL have been derived from the NOAEC of 6300 mg/m3 coming from the read-across (90 day inhalation study with methylal_Hofman, 1994).
It is important to note that no alert has been found among the mechanistic profilers relevant for repeated dose toxicity in the read-across report with source methylal and target butylal, supporting the similarity of toxicokinetic behavious of both compounds (Pavan, 2016).
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Selected as only subchronic study available.
Justification for classification or non-classification
No study available
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