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Diss Factsheets
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EC number: 205-592-6 | CAS number: 143-22-6
- 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
Key value for chemical safety assessment
Effects on fertility
Additional information
Testing proposal made for TEGME with the results to be used to predict the toxicity of TEGBE in conjuntion with new OECD422 screening studies used to bridge data gaps.
Effects on developmental toxicity
Description of key information
Study |
Result |
Comment |
TEGBE |
||
Chernoff Kavlock reproductive and developmental toxicity oral screening study |
NOAEL (devtox): 1000mg/kgbw/day No statistically significant effects at maximum tested dose |
Similar results also seen with TEGME and TEGEE. |
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
Additional information
- No effect on litter size, pup weight, survival or pup weight gain.
- No reduction in litter size (mean less than 8) or reduced post natal survival (screening criteria for teratogenicity)
- No reduction on post natal weight gain (<30%) with no reduction in survival (screening criteria for foetal toxicity)
There is data from available from a developmental toxicity screening test on TEGBE supplied as supporting evidence for this end point. Whilst this does not meet the requirements for this end point on its own, it has value as a bridging study to the developmental toxicity studies of the source substances. In this screening study, Wistar derived rats were exposed GD7-16 to TEGBE (250, 1000 mg/kg, plus negative and positive controls (latter methoxyethanol at 50 and 250 mg/kg). 10 animals were used per dose level and in concurrent controls. The criteria for evaluation were that for a substance to pass the screen and show no potential for reprotoxicity, there should be:
TEGBE was also evaluated using the zebrafish embryotoxicity test (ZET). The morphological characteristics of each embryo were assessed at 72 and 96 hours post fertilization (hpf) following exposure to the test substance at various concentrations up to a maximum tolerated dose ascertained by a dose range finder study. At 72 hpf, the embryos were evaluated for dead or alive. At 96 hpf, the embryos and larvae were evaluated for a wide series of normal or anomalous developmental characteristics. TEGBE was found to cause some delay in hatching in 25% of embryos. Although this was significantly lower than the delays seen in the concurrent controls, it was within the range of controls used throughout this study which examined 10 substances in total. The positive controls (ethanol and methoxyacetic acid) used exhibited a wider range of developmental effects (growth retardation and malformations). This result is considered unclear.
2-(2 -(2-butoxyethoxy)ethoxy)acetic acid (TEGBEAA) was evaluated using the zebrafish embryotoxicity test (ZET). TEGBEAA was evaluated as this assay does not have metabolic capacity and TEGBEAA is the main metabolite of 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol, the subject of this dossier. The morphological characteristics of each embryo were assessed at 72 and 96 hours post fertilization (hpf) following exposure to the test substance at various concentrations up to a maximum tolerated dose ascertained by a dose range finder study. At 72 hpf, the embryos were evaluated for dead or alive. At 96 hpf, the embryos and larvae were evaluated for a wide series of normal or anomalous developmental characteristics. TEGBEAA was considered as positive by the study authors in the embryonic zebrafish screening test. Only two end points were affected, one associated with embryotoxicity (pericardial edema) and the other with teratogenicity (malformations of the chorda/spine). Neither of these effects was seen in the negative control. The former is seen extensively with methoxyacetic acid but the latter only with 2% ethanol. The NOAEL was 2.5mM (550mg/L).
A testing proposal for an OECD414 study in rats has been submitted for this substance.
Justification for classification or non-classification
Whilst there is limited data avaible for the developmental toxicity of this substance, No signficant adverse effects are seen on reproductive parameters at doses <1000mg/kgbw/day from the available data. On this basis, there is no data to suggest that the substance meets the criteria for classification either as a developmental or reprotoxic substance. Whilst the results from the ZET are equivocal and could even be considered positive for the acid metabolite of TEGBE, this assay is not sufficient on which to base a classification decision. Further data will be generated for these endpoints.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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