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Diss Factsheets
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EC number: 228-567-1 | CAS number: 6297-03-6
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Results from a developmental toxicity study and a subchronic toxicity study did not reveal any reason of concern for offspring and for parent animals with respect to developmental toxicity or fertility. Since significant scientific evidence for a lack of reprotoxic effects of the substance is drawn from these results and an additional two generation study is not expected to add any further relevant knowledge on this endpoint. Due to animal welfare aspects and/or laws, an additional study is therefore not warranted.
Short description of key information:
no study is available; no effects are expected from results obtained in a 90 day study and in a developmental study
Effects on developmental toxicity
Description of key information
developmental toxicity (rat): NOAEL > 1000 mg/kg bw
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
In the prenatal developmental toxicity study, the homolog dioctylether was administered to female rats at dose levels of 100, 300 and 1000 mg/kg bw orally, by gavage from the 6th to 19th day of pregnancy. Under the present test conditions, the no-observed-effect level (NOEL) was above 1000 mg/kg bw for the dams. The NOEL for the fetuses was also above 1000 mg/kg bw. No test item-related malformations or variations were noted during external/internal examination of the fetuses or soft tissue examination (according to Wilson); skeletal examination (according to Dawson) revealed no test item-related malformations, variations or retardations.
In conclusion, the test substance possessed no teratogenic properties. No test item-related increase was noted in the incidence of malformations, variations and retardation tested until the dose of 1000 mg/kg bw.
Dioctylether is used as a read-across substance for distearylether. The only difference is the longer alkyl chain. Dioctylether is regarded as a worst case in this respect because of the higher bioavailability due to the lower molecular weight. Furthermore, the possible meatbolite stearyl alcohol does not present a teratogenic compound. Therefore, it is unlikely that the ether of stearyl alcohol which might also build in the human body is a teratogenic compound.
Based on the reliability and relevance, this study has been used as key study.
Justification for classification or non-classification
Based on results of the key study the substance does not need to be classified according to GHS (Regulation (EU) 1272/2008) and also does not need to be classified according to DPD (67/548/EEC).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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