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Diss Factsheets
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EC number: 939-682-8 | CAS number: -
- 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
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
Long-term toxicity testing on fish is a standard requirement for aquatic toxicity according to Annex IX of REACH Regulation. Since N,N-dimethyl-C12-14-(even numbered)-alkyl-1-amines, reaction products with potassium hydroxide and chloroacetic acid (EC 939-682-8) is registered at a volume of >1000 tpa and a data gap has been identified for long-term toxicity to fish, it is proposed to run a fish early-life stage toxicity test according to OECD 210 guideline.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : N,N-dimethyl-C12-14-(even numbered)-alkyl-1-amines, reaction products with potassium hydroxide and chloroacetic acid (EC 939-682-8).
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- GLP / non-GLP studies : no experimental long-term fish toxicity study has ever been performed on the substance EC 939-682-8;
- Historical human/control data : not applicable for this endpoint;
- (Q)SAR : no relevant QSAR model exists to predict the long-term toxicity to fish of surface-active substances such as the substance EC 939-682-8;
- In vitro methods : not applicable for this endpoint;
- Weight of evidence : no data have been identified that could be used in a WoE approach for this endpoint;
- Grouping and read-across : no appropriate long-term fish toxicity data have been found on any relevant alkyl dimethyl betaine analogue; long-term fish toxicity data exist on less closely related cocoamidopropryl betaine substances and were used in the past to fill the datagap identified for the substance EC 939-682-8; it is however expected that ECHA will challenge the robustness of this read-across approach and will request a long-term fish toxicity test to be performed on the substance EC 939-682-8 itself;
- Substance-tailored exposure driven testing: not applicable for this endpoint;
- Approaches in addition to above: not applicable for this endpoint;
- Other reasons: not applicable 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:
- Column 2 of Section 9.1 of Annex IX was long-time considered as a "trigger" by registrants, i.e. one of the three fish tests listed in Column 1 shall be proposed if the CSA shows it is needed. Based on this interpretation of Column 2 and according to the information available on the substance EC 939-682-8 (long-term toxicity on Daphnia sp., fish species not expected to be more sensitive than aquatic invertebrate species based on short-term toxicity dataset, all risk covered in the CSA), no long-term fish toxicity study has ever been proposed in the past.
- Several cases dealing with the interpretation of Column 2 of Section 9.1 of Annex IX were discussed before the Board of Appeal in 2020-2021 (e.g. case A-011-2018, case A-010-2019). According to the decisions made by the Board of Appeal, long-term toxicity testing on fish is a mandatory requirement for REACH registration dossiers of >100 tpa, unless waived under Annex XI.
- As long-term toxicity testing on fish cannot be waived under Annex XI for the substance EC 939-682-8, it is proposed to run a fish early-life stage toxicity test according to OECD 210 guideline.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: not relevant. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Reference
Description of key information
Long-term toxicity testing on fish is a standard requirement for aquatic toxicity according to Annex IX of REACH Regulation. Since N,N-dimethyl-C12-14-(even numbered)-alkyl-1-amines, reaction products with potassium hydroxide and chloroacetic acid (EC 939-682-8) is registered at a volume of >1000 tpa and a data gap has been identified for long-term toxicity to fish, it is proposed to run a fish early-life stage toxicity test according to OECD 210 guideline.
Key value for chemical safety assessment
Additional information
Column 2 of Section 9.1 of Annex IX was long-time considered as a "trigger" by registrants, i.e. one of the three fish tests listed in Column 1 shall be proposed if the CSA shows it is needed. Based on this interpretation of Column 2 and according to the information available on the substance EC 939-682-8 (long-term toxicity on Daphnia sp. on the analogue substance EC 931-700-2, fish species not expected to be more sensitive than aquatic invertebrate species based on short-term toxicity dataset, all risk covered in the CSA), no long-term fish toxicity study has ever been proposed in the past.
Several cases dealing with the interpretation of Column 2 of Section 9.1 of Annex IX were discussed before the Board of Appeal in 2020-2021 (e.g. case A-011-2018, case A-010-2019). According to the decisions made by the Board of Appeal, long-term toxicity testing on fish is a mandatory requirement for REACH registration dossiers of >100 tpa.
For the record, a long-term fish toxicity data exists on the cocoamidopropryl betaine analogue substance EC 931-700-2 (NOEC = 0.135 mg/L) and was used in the past to fill the datagap identified for the substance EC 939-682-8. It is however expected that ECHA will challenge the robustness of this read-across approach and will request a long-term fish toxicity test to be performed on the substance EC 939-682-8 itself. It is therefore proposed to run a fish early-life stage toxicity test according to OECD 210 guideline on the substance EC 939-682-8. In the meantime, the long-term fish NOEC value of 0.135 mg/L from the cocamidopropyl betaine analogue is used for PNEC derivation.
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.
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