Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 629-715-1 | CAS number: 1226892-43-8
- 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
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study planned
- Remarks:
- The long-term toxicity to fish is a standard information requirement for annex IX registrations. It is therefore proposed to perform a long-term fish test according to OECD TG 210 in agreement with OECD guidance 23 (2019) with AAI-DETA (EC no. 629-715-1)
- Study period:
- Q2-3 in 2024
- Justification for type of information:
- AAI-DETA (EC no. 629-715-1; CAS no. 1226892-43-8)
Justification for type of information
TESTING PROPOSAL ON LONG-TERM TOXICITY TO FISH
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out:
The test will be performed with Fatty acids, C18 (unsaturated), reaction products with diethylenetriamine (EC no. 629-715-1; CAS no. 1226892-43-8).
- Name of the substance for which the testing proposal will be used: The testing proposal is intended
to be used for the tested substance, Fatty acids, C18 (unsaturated), reaction products with diethylenetriamine.
In addition, the results may serve as read-across data endpoint for two other AmidoAmines/ imidazoline substances for which already draft decisions were issued: Fatty acids C18 unsat, reaction products with tetraethylenepentamine (AAI-TEPA; EC number: 629-725-6) and Amides, fatty acids C18 unsat, reaction products with polyethylene amines ((AAI-PEHA; EC number: 629-735-0).
Whether the test substance is indeed a suitable source substance for read across will depend on whether the read across hypothesis is true i.e. that there besides to the structurally similarity and similar fate properties of the substances, there is evidence from bridging studies of comparable design and duration for the AAI-DETA Substance and for the target substances.
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP/non-GLP studies: Neither GLP nor non-GLP studies are available investigating the
long-term toxicity of Fatty acids, C18 (unsaturated), reaction products with diethylenetriamine to fish.
- Historical human data: not applicable
- (Q)SAR: No valid QSAR methods able to reliably estimate the long-term toxicity to fish are available AmidoAmines/Imidazoline surfactants.
- In vitro methods: No respective in vitro methods are available.
- Weight of evidence: The currently available data were considered inadequate to serve as basis for a Weight of evidence approach.
- Grouping and read-across: In addition, the result of the long-term fish test may be used in a read-across approach for the other two AmidoAmines/Imidazolines.
It is expected that the test result will confirm our assumption that fish are also on a long-term less sensitive when compared to algae
- Approaches in addition to above: none
- Other reasons: none
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (A
ND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE
THE NECESSARY INFORMATION:
Experimental data about the long-term toxicity of AAI-DETA to fish is needed for the hazard assessment due to the environmental behavior (difficult substance, not-readily biodegradable) and the intrinsic toxicity observed in the algae and long-term daphnia test.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED
IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The endpoint is a standard information requirement and because there are no acceptable alternatives available (adaptations according to REACH Annex XI) we propose to perform a long-term fish test according to OECD TG 210.
The Substance is difficult to test due to the adsorptive, ionisable and surface active properties as explained above and therefore during testing the OECD GD 23 will be followed as far as technically possible. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- GLP compliance:
- yes
Reference
Description of key information
The long-term fish test is a standard information requirement according to Annex IX registrations a long-term toxicity to fish test according to OECD 210 has been proposed.
Key value for chemical safety assessment
Additional information
The long-term fish test is a standard information requirement according to Annex IX registrations therefore a long-term toxicity to fish test according to OECD 210 has been proposed.
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.