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EC number: 807-159-2 | CAS number: 69701-99-1
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- assessment of toxicokinetic behavior
- Type of information:
- other: In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
- Adequacy of study:
- key study
- Study period:
- The assessment was conducted in March 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Relevant studies were reviewed with a view to fulfilling the requirements of Annex VIII (8.8).
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behaviour has been conducted to the extent that can be derived from the relevant available information. The assessment is based on the Guidance on information requirements and chemical safety assessment R.7c: Endpoint specific guidance (ECHA, June 2017)
- GLP compliance:
- no
- Remarks:
- Not relevant for assessment
Test material
- Reference substance name:
- (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- EC Number:
- 807-159-2
- Cas Number:
- 69701-99-1
- Molecular formula:
- C10H16O4
- IUPAC Name:
- (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
Results and discussion
Any other information on results incl. tables
Toxicokinetic Behaviour:
The substance is a liquid with a molecular weight of 200.23 g/mol.
The substance does not have any hazardous phys-chem properties but has a vapour pressure of 6.8 Pa at 25°C and therefore inhalation is considered as a possible route of exposure.
The substance is highly water soluble (12.92 g/L at 20°C) and has a relatively low log octanol/water partition coefficient (Log Kow = 1.92).
There were signs of toxicity in acute oral and inhalation studies.
A repeated dose toxicity with reproduction screening study (OECD 422) showed a number of effects, in particular histopathological changes to the non-glanduar stomach, but these were considered to be test item related local irritation and not systemic toxicity.
The substance is classified as both a skin irritant and skin sensitiser.
The substance was non-mutagenic in bacteria (Ames study). The substance was positive (clastogenic) to human lymphocytes in-vitro (OECD 487) study (both in absence and presence of an auxiliary metabolising system).
Absorption
Absorption of the substance from the gastrointestinal tract (GI) following oral ingestion is considered likely to occur based on the substance molecular weight (molecular weights below 500 are favourable for absorption), high water solubility and log Kow (moderate values between -1 and 4 are favourable for absorption by passive diffusion). The results of an acute oral study (showing signs of systemic toxicity at 2000 mg/kg) suport that some absorption via the GI tract has occured. The OECD 422 stdy shows limited results to support absorption as the stomach effects were related to local irritaiton.
Respiratory absorption following inhalation exposure is considered likely to occur as the substance is volatile due to high vapour pressure. The substances log Kow (between -1 and 4) is favourable for absorption across the respiratory tract epithelium by passive diffusion. The results of an acute inhalation toxicity study, where mortality and clinical signs were observed, support that absorption occurred following inhalation exposure.
Some absorption may also take place via the skin, based on the substances molecular weight, water solubility and log Kow. The substance is classified as a skin irritant (based on in-vitro study) so damage to the skin surface may enhance penetration. The substance is classified as a skin sensitiser (based on in-vitro data), so it can be assumed possible that some dermal uptake can occur.
Distribution
The molecular weight of the substance and its high water solubility indicates that any absorbed substance may be readily distributed in the water fraction of circulatory fluids.
The positive skin sensitisation response suggests that the substance can bind to carrier/circulatory proteins in blood, which may aid systemic distribution.
The relatively low Log Kow (1.92) suggests the substance is not sufficiently lipophilic to make it likely that it will accumulate within fatty/adipose tissues.
Metabolism
The results of the OECD 422 study did not show evidence to indicate any substance influenced hepatic metabolism.
Although the results of two in vitro genotoxicity assays showed both positive and negative results, genotoxicity was neither enhanced nor diminished in the presence of S9 metabolising system in the studies.
The high water solubility and molecular weight of the substance suggest that metabolism may not be necessary to facilitate excretion.
Excretion
There is no evidence to indicate the route of excretion of the substance. However, it is likely that the kidney will be the favourable route for urinary excretion due to the substances high water solubility and molecular weight (below 300).
Applicant's summary and conclusion
- Conclusions:
- The available information of the substance suggests that absorption from the GI tract can occur following oral ingestion, respiratory absorption following inhalation exposure can occur and that some dermal absorption may occur. Absorbed substance may be available for systemic distribution. There is no evidence to indicate the substance will be metabolized and excretion via urine is likely to be the significant route of excretion.
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