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Diss Factsheets
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EC number: 471-490-5 | CAS number: 7682-20-4
- 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
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- (S)-2-Aminobutanamide hydrochloride
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Reference substance:
- (S)-2-Aminobutanamide hydrochloride
- PBT status:
- the substance is not PBT / vPvB
- Justification:
8. PBT AND vPvB ASSESSMENT
8.1. Assessment of PBT/vPvB Properties
8.1.1. PBT/vPvB criteria and justification
8.1.1.1. Assessed substance: substance itself
PBT status of the assessed substance: the substance is not PBT / vPvB
8.1.1.1.1. Persistence assessment
Evidence of non-P / non-vP properties
Screening criteria
- Not P / vP based on ready biodegradability: As determined in a GLP study according to OECD 301A, the substance was shown to be readily biodegradable.
Conclusion on P / vP properties:not P/vP.
8.1.1.1.2. Bioaccumulation assessment
Evidence of non-B / non-vB properties
Screening criteria
- Remarks on criterion “Log Kow<=4.5”: The log Pow of the substance at 20°C is -3.57, as estimated from the ratio n-octanol solubility (133.2 mg/L) and water solubility (490 g/L) in a GLP study according to OECD 107.
Conclusion on B / vB properties:not B/vB.
8.1.1.1.3. Toxicity assessment
Conclusion on T properties:No conclusion can be reached based on available information.
- Environmental toxicity: All acute L(E)C50 values are ≥ 0.1 mg/L (>100 mg/L) and therefore this screening criterion for T is not fulfilled. The NOEC to algae is 100 mg/L. For a definitive classification as not T, a long-term aquatic NOEC ≥ 0.01 mg/L to daphnia (and/or fish) would be necessary.
- Human health toxicity: The substance is not considered to fulfil the toxic criterion as:
-- The substance does not meet the criteria for classification as carcinogenic, germ cell mutagenic or toxic for reproduction according to the CLP Regulation;
-- There is no other evidence of chronic toxicity; the substance does not meet the criteria for classification as STOT RE 1 or STOT RE 2 according to the CLP Regulation
8.1.2. Summary and overall conclusions on PBT or vPvB properties
Overall conclusion:Based on the assessment described in the subsections above the submission substance is not a PBT / vPvB substance.
Justification:
The screening criteria as mentioned in the ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT assessment are used to decide whether the substance potentially fulfils the PBT or vPvB criteria. As the substance was shown to be readily biodegradable, the substance is not P/vP. Based on the log Pow (and water solubility) of the substance, the substance is also not B/vB. Although the substance does not fulfil the toxic criterion with regard to human health toxicity and the acute L(E)C50 values are >100 mg/L, a definitive classification as not T is not possible, due to the lack of chronic environmental toxicity studies. However, since the substance is not P/vP and not B/vB, it can be concluded that the substance is not PBT/vPvB.
Reference
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.