Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 918-139-9 | CAS number: 1228577-90-9
- 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:
- Note: Dependent on results of first species (rat) OECD 414 developmental toxicity study, see read-across strategy and agreed testing strategy presented in Section 13
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
DISCLAIMER:
This testing proposal is based on the knowledge at the time of the dossier update submission. In reference to the agreed testing strategy presented in Section 13 of the dossier and in line with the dossier improvement pilot project (Cefic, ECHA, 2020) bridging data are currently being generated. The registrant upholds the option to re-evaluate and refine the strategy, the best suitable test substance, order and extent of studies performed to fulfill the registration requirements, as soon as the study results become available.
A preliminary read-across justification including a matrix of the available data can be founds in Section 13 of the dossier. As soon as the results of the bridging study (OECD 422) with o-TDA-EO-PO are available, the read-across justification will be adapted.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
Same as substance being registered.
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
[please address all points below]:
- Available GLP studies: none available
- Available non-GLP studies: none available
- Historical human data: none available
- (Q)SAR: QSAR is not an appropriate method to address second species developmental toxicity endpoint
- In vitro methods: none available to address the information requirement for developmental toxicity in second species
- Weight of evidence: none available
- Grouping and read-across: see read-across strategy and agreed testing strategy presented in Section 13
- Substance-tailored exposure driven testing [if applicable]: technically not possible due to potential exposure to the substance
- Approaches in addition to above [if applicable] : not applicable
- Other reasons [if applicable]: 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:
At over 1000 tons the second species developmental toxicity study is a mandatory requirement. The substance is not classified as a Category 1 carcinogen or mutagen nor is it classified for reproductive toxicity already. In addition, although the substance has a very low order of toxicity, it is not possible to rule out the potential for systemic exposure or potential human exposure, therefore it is not possible to waive in accordance with Column 2.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
We propose to conduct an oral gavage OECD 414 in the rabbit.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2-Diaminotoluene, propoxylated
- EC Number:
- 918-139-9
- Cas Number:
- 1228577-90-9
- Molecular formula:
- (C3H6O)n (C3H6O)n (C3H6O)n (C3H6O)n C7H10N2 sum of n: >1 - <8.5
- IUPAC Name:
- 1,2-Diaminotoluene, propoxylated
- Details on test material:
- - Name of test material (as cited in study report): Tercarol 5903
- Molecular weight: Mn = 340 g/mole
- Physical state: liquid (red viscous)
- Content: > 99%
- Storage : room temperature under light protection
Constituent 1
- Specific details on test material used for the study:
- Representative sample of the test substance.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
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.