Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 221-220-5 | CAS number: 3033-62-3
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Type of information:
- experimental study planned
- Study period:
- to be determined by ECHA
- Justification for type of information:
- TESTING PROPOSAL ON VETEBRATE ANIMALS:
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: Prenatal Development Toxicity study (oral gavage, rat) crf. OECD 414 (performed in 1985).
- Available non-GLP studies: no non GLP studies which are relevant for this endpoint
- Historical human data: no human data are available which can provide input for this endpoint
- (Q)SAR: no QSARs were performed for this endpoint
- In vitro methods: not available for this endpoint
- Weight of evidence: not available for this endpoint
- Grouping and read-across: not available for this endpoint
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The registrant submitted a waiver for performing this test in its dossier : "A developmental toxicity study in a second species will not be performed. The substance was demonstrated to display no significant adverse effects in a two-generation toxicity study in rats or in a prenatal developmental toxicity study in rats. Therefore, it is deemed unlikely that a prenatal development toxicity study in a second species would have added value." This was not accepted by the ECHA. Therefore, the registrant doesn't see another option apart from performing the PND test in a second species.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: OECD 414 will be performed in rabbits.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
- Justification for study design:
- SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS:
- Premating exposure duration for parental (P0) animals : cfr. OECD guideline
- Basis for dose level selection: to be confirmed, based on available information (repeated dose studies)
- Exclusion of developmental neurotoxicity Cohorts 2A and 2B: no particular concerns identified. Therefore, suggested not to include additional cohorts.
- Exclusion of developmental immunotoxicity Cohort 3: no particular concerns identified. Therefore, suggested not to include additional cohorts.
- Route of administration: oral
- Other considerations, e.g. on choice of species, strain, vehicle and number of animals [if applicable]: rat
Test material
- Reference substance name:
- N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)
- EC Number:
- 221-220-5
- EC Name:
- N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)
- Cas Number:
- 3033-62-3
- Molecular formula:
- C8H20N2O
- IUPAC Name:
- {2-[2-(dimethylamino)ethoxy]ethyl}dimethylamine
- Test material form:
- liquid
Constituent 1
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
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.