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EC number: 204-001-9 | CAS number: 112-73-2
- 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
Link to relevant study record(s)
Description of key information
2-Butoxyacetic acid is the toxic metabolite of DEGDBE, responsible for the hemolytic effect. Humans are more resistent towards toxicity of 2-butoxyacetic acid.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Toxicokinetic assessment:
DEGDBE is expected to be readily bioavailable via oral/dermal/inhalation routes.
DEGDBE is expected to undergo extensive metabolism. The presumed metabolites are 2 -(2-butoxyethoxy)acetic acid and 2 -butoxyacetic acid, which is supported by that these ompound are known to induce hemolysis and that clear indications of hemolysis were found in the available toxicity studies. 2 -Butoxyacetic acid is known to be far more potent than 2 -(2-butoxyethoxy)acetic acid.
In the 28 -day oral toxicity study, the urines obtained from DEGDBE treated rats were analyzed for 2 -butoxyacetic acid. No bioaccumulation property can be derived based on the very low values obtained from rats that were allowed to recover.
Study summary:
Rats were treated via gavage with DEGDBE at doses of 0. 25. 100. 250 and 750 mg/kg bw for up to 28 days. The 24 -h urine samples were collected after 8 day and 28 day treatment and after recovery phase of up to 14 days and analyzed for the presumed toxic metabolite 2 -butoxyacetic acid. The obtained values were dose dependent and ranged to 1400±600 mg/L. Comparable values were obtained in the samples of 28 -day treatment, indicating that steady-state of 2 -BAA systemic burden was established within the treatment period. An efficient 2 -butoxyacetic acid clearance could be demonstrated by low levels of 2 -BAA for recovery animals.
Discussion on the results and relevance to other endpoints:
- The study confirms the 2 -butoxyacetic acid as the metabolite of DEGDBE in rats. Together with the known toxicity profile of DEGDBE (hemolysis), it is reasonably to conclude 2 -butoxyacetic acid as the toxic metabolite of DEGDBE and the systemic exposure to 2 -butoxyacetic acid as the mode of action of DEGDBE. Therefore, the read-across appraoch used for endpoints developmental toxicity, repeated dose toxicity and skin sensitization potential is justified.
- Further, the study result is to be used to justify the no need of a 2-generation study, because it is known that 2 -butoxyacetic acid does not induce testicular toxicity. It is not likely that there will be any new effects in the 2 -generation study that were not present in the provided OECD 421 study or in the available developmental toxicity studies on DEGDBE or on its source chemicals.
- The values obtained for rats treated for 8 days and 28 days were comparable, indicating that the steady-state was established in the early phase of the treatment period. Further, the values obtained for the recovery animals are indicative of a very efficient clearace. A significant bioaccumulating potential cannot be derived. The NOAEL obtained in the 28 -day study was 100 mg/kg bw based that there were indications of hemolysis at 250 mg/kg bw. Considering that the effects found at 250 mg/kg bw were actually not associated with adverse health effect , no significant effect after prolonged exposure up to the dose of 100 mg/kg bw can be derived. The provided 28 -day toxicity study is considered to be sufficiently reliable to derive the chronic toxicity.
- The proposed read-across approach includes the use of data on ethyleneglycolbutylether (EGBE). It is well acknowleged that EGBE induce its toxic effects via 2 -butoxyacetic acid and that humans are resistent to 2 -butoxyacetic acid. The existing official reviews on EGBE are of the opinion that there is no significant concern for humans. Likewise, no concern can be derived for DEGDBE.
- Finally, the study results together with all the consideration mentioned above justify the DNEL derivation (no AF for duration exposure; no AF for additional factor for interspecies extrapolation; an AF of 2.5 for interspecies extrapolation).
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