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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 248-948-6 | CAS number: 28299-41-4
- 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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Long-term toxicity to fish
Administrative data
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- According to REACH Annex IX, 9.1.6. ‘Long-term toxicity testing on fish, (unless already provided as part of Annex VIII requirements)’ is a standard information requirement and cannot be generated otherwise. This is based on BoA decisions A-010-2018 and A-011-2018. The BoA in A-011/2018 came to the conclusion that registrants are required to propose long-term fish testing under Annex IX in any case, and that registrants may be required to perform / shall propose (under column 2) longer term fish toxicity tests that go beyond those described in Annex IX, column 1. According to the BoA, Annex IX (section 9.1, column 2) does not allow registrants to omit information on long term toxicity to fish under column 1. Rather, according to the BoA, Annex IX requires registrants to submit information on a further study than one of the three listed in Column 1 of Section 9.1.6. of Annex IX, if the chemical safety assessment indicates that it is necessary to investigate the effects of a substance on aquatic organisms beyond what any one of those three Column 1 studies would do. The Fish Early Life Stage (FELS) toxicity test (OECD TG 210) is regarded as the most suitable test guideline for addressing the information requirements.
However, the registrant would like to point out, that the performance of a long-term toxicity study of ditolyl ether to fish is not needed as:
- The toxicity of ditolyl ether to freshwater aquatic organisms is documented by several acute aquatic studies in three trophic levels (fish, daphnid, algae) and long-term studies in two trophic levels (daphnid and algae). The results of the acute toxicity studies indicate that algae are the most sensitive species with an EC10 of 0.035 mg/L algae qualify as 75 times more sensitive than fish with 2.62 mg/L.
- In the chemical safety assessment of ditolyl ether no risk to the aquatic compartment is identified for all relevant uses (PEC/PNEC < 1), so that a refinement of the PNECaquatic is not required.
In addition, ECHA decision number SEV-D-2114341466-49-01/F in request 8 states: "If one of the DTE isomers is already found to meet the criteria for vPvB and/or PBT in accordance with REACH Annex XIII, this request does not need to be addressed." As the substance is classified vP, further testing of the Bioaccumulation in fish needs to take place as a first measure to establich a classification of B or vB properties of the substance. cf. section 5.3.1 of this dossier.
Depending upon the outcome and evaluation of the Bioaccumulation study, the registrant will potentially perform aquatic toxicity tests, following the tiered requirements as requested in the ECHA decision SEV-D-2114341466-49-01/F.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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