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Registration Dossier
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EC number: 701-138-0 | CAS number: 242482-67-3
- 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

Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- no hazard identified
Marine water
- Hazard assessment conclusion:
- no hazard identified
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 11.44 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- no hazard identified
Sediment (marine water)
- Hazard assessment conclusion:
- no hazard identified
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no hazard identified
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
The submission substance - or by read across its supporting substances - was tested at high concentrations of 100 mg/L or higher. No effects were observed in reliable (RL 1 or RL 2) acute toxicity tests with freshwater organisms of three trophic levels and in a reliable (RL 2) test on a marine fish species (turbot). Other tests on marine species are available, however judged to be not reliable. Consequently, no LOEC, NOEC, or ECx - value can be calculated. Since these data are a prerequisite to estimate a PNEC_freshwater and further on by equilibrium partitioning a PNEC_sediment or PNEC_soil, it is not possible to derive these values.
Sediment or soil are not anticipated to be relevant compartments for the submission substance: It has a low potential for adsorption to sediment or soil. Its log Pow is < 3.0, and the calculated log Koc-value for the neutral 6-(Isononanoylamino)hexanoic acid moiety using KOCWIN v2.00 (US-EPA EPI Suite v. 4.11) is between 1.50 (estimate based on experimentally determined log Kow of 2.47 for the non-dissociated acid moiety) and 2.44 (estimate according to molecular connectivity index based method). These values corroborate low adsorption potential. Actual adsorption potential will still be lower:
1) The experimental log Kow for 6-(isononanoylamino)hexanoic acid, compound with 2,2’,2’’-nitrilotriethanol is -0.04 due to the compound being an organic salt, and its charged nature.
2) The predicted pKa for 6-(Isononanoylamino)hexanoic acid moiety is 4.69. Thus, at pH 7.0, 99.5% will be negatively charged (dissociated). Negatively charged compounds are known to have a lower tendency to sorb compared to non-charged analogues.
Furthermore, the submission substance is readily biodegradable and environmental concentrations will be very low.
Two reliable (2xRL1 and RL2) studies on STP microorganism toxicity (activated sludge respiration inhibition tests according to OECD 209 and compliant to GLP) are available for the submission substance and by read across its supporting substances with following results:
For 6-(isononanoylamino)hexanoic acid, compound with 2,2’,2’’-nitrilotriethanol, no respiration inhibition was observed up to the highest tested concentration of 10000 mg/L (reliability category 1).
In the test on 6-(isononanoylamino)hexanoic acid Tween 80 was used to enhance solubility of the otherwise poorly soluble test item far above the level of water solubility, which renders the study reliable with restrictions (RL 2). In spite of artificially high concentration levels due to the solubilizer, observed respiration inhibition was comparably low with an observed EC20 (3h) of 386 mg/L and an EC50 (3h) of 1144 mg/L (key value for safety assessment). Thus, under natural conditions taking the poor solubility of 6-(isononanoylamino)hexanoic acid into account, no toxicity towards sewage treatment plant microorganisms is expected also for this compound.
Secondary poisoning is highly unlikely: As pointed out above, the submission substance being an organic acid with an estimated pKa of 4.69 is under environmentally relevant conditions almost completely present in its dissociated form, i.e. negatively charged. Experimentally determined log Kow values are therefore low, i.e. between 2.47 (free acid) down to -0.04 (salt). It is known that ionic compounds have a low potential to cross membranes and to bio-accumulate. Therefore, it is highly unlikely that the submission substance would present any relevant bioaccumulation potential. Log Kow is far below the screening criterion on B of 4.5. In addition, the submission substance is readily biodegradable. Thus environmental concentrations will be very low. In accordance with ECHA Guidance on Information Requirements and CSA, Part B, assessment of secondary poisoning is not necessary.
Conclusion on classification
The submission substance - or by read across its supporting substances - was tested at high concentrations of 100 mg/L or higher. No effects were observed in reliable (RL 1 or RL 2) acute toxicity tests with freshwater organisms of three trophic levels and in a reliable (RL 2) test on a marine fish species (turbot). In addition, due to being readily biodegradable, long term effects in the environment can be excluded for the submission substance. In conclusion, no environmental classification is proposed.
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