Registration Dossier
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EC number: 264-261-4 | CAS number: 63469-23-8
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Study period:
- To be determined by ECHA
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : 1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies :
A combined repeated dose toxicity study with reproduction/developmental toxicity screening test was performed with the test substance (according to OECD guideline 422; Betancourt Martell A, 2013)
- Available non-GLP studies :
Acute toxicity (oral): Acute oral toxicity study in rats, Auletta CS, 1979, K2
Acute toxicity (dermal): Acute dermal toxicity study in rabbits, Auletta CS, 1979, K2
Skin irritation (in vivo): Primary Dermal Irritation in Rabbits, Moreno OM, 1979, K2
Skin irritation (in vivo): Report on DOT test for material corrosivity in albino rabbits, Moreno OM, 1979, K2
Eye irritation (in vivo): Report on Rabbit Eye Irritation, Moreno OM, 1979, K2
- Historical human data : No data available
- (Q)SAR : No (Q)SAR data can be used in a stand alone approach to assess the developmental toxicity potential. According to ECHA guidance document R.7a (Dec 2016), QSAR approaches are currently not fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction
- In vitro methods : Some in vitro methods have been developed; however, according to ECHA Guidance document R.7a (Dec 2016) these in vitro methods have not reached regulatory acceptance and do not provide equivalent information.
- Weight of evidence: No data is available which would allow a weight of evidence approach
- Grouping and read-across: There is an unacceptable level of uncertainty regarding identification and selection of structurally and/or mechanistically related source substances.
- Substance-tailored exposure driven testing: The registered substance is only handled in industrial or commercial installations using closed systems and/or handled only as preparations at low concentrations, a sub-chronic study should be considered.
- Approaches in addition to above: not applicable
- Other reasons: not applicable
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:
- This test proposal is fully compliant with the ECHA guidance document R.7a (Dec 2016). It is not possible to waive the study based on column 2 adaptations of the REACH regulation.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- No additional information
Data source
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
- Details on test material:
- Details described in study specific records
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
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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