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Diss Factsheets
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EC number: 701-003-6 | 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Written assessment
- Type of information:
- other: Written assessment
- Adequacy of study:
- other information
- Study period:
- December 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Written assessment
- Justification for type of information:
- At the current level of registration, a written assessment is suitable. Please see attached justification below.
Data source
Reference
- Reference Type:
- other: Written assessment
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
- Objective of study:
- other: Written assessment of ADME
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Written assessment based on available study data.
Test material
- Reference substance name:
- Amidation products of C16-18 (even numbered), C18 unsaturated fatty acids esters with 1,1'-iminodipropan-2-ol
- EC Number:
- 701-003-6
- Cas Number:
- 1454803-04-3
- Molecular formula:
- C20H39NO3 to C26H51NO3
- IUPAC Name:
- Amidation products of C16-18 (even numbered), C18 unsaturated fatty acids esters with 1,1'-iminodipropan-2-ol
- Test material form:
- liquid
- Details on test material:
- Identification: MLA-3202
Appearance: Clear amber-red liquid
Purity/Composition: UVCB
Test item storage: At room temperature
Stable under storage conditions until 17 February 2019 (expiry date)
Purity/composition correction factor: No correction factor required
Chemical name (IUPAC), synonym or trade name: Amides, tallow, N,N-bis(2-hydroxypropyl)
CAS Number: 1454803-04-3
Test item handling No specific handling conditions required
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- See above justification
- Details on distribution in tissues:
- See above justificationSee above justification
- Details on excretion:
- See above justification
Metabolite characterisation studies
- Details on metabolites:
- See above justification
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- See above justification
Applicant's summary and conclusion
- Conclusions:
- In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route, but for worst case risk assessment, 100% absorption is proposed. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. This is further confirmed by the extensive metabolic studies conducted on the closely related substance lauramide DEA. Lauramide DEA, following absorption in rodents, is metabolized to the half-acid amides of succinic and of adipic acid. These metabolites would arise from the ω-hydroxylation and eventual β-oxidation to give the chain-shortened products. The metabolism studies conducted by Mathews et al. (1996) on the analogue demonstrate that the amide moiety is not hydrolysed; hence the lack of potential for amine formation. Since ω-hydroxylation and β- oxidation are the only noted means of metabolism (these are common metabolic pathways for dietary fatty acids and triglycerides), there is no possibility that reactive, or potentially mutagenic intermediates, can be formed. The metabolic data on the close structural analogue lauramide DEA corroborates the conclusion that the substance is not considered to be bioaccumulative, and would be metabolised for elimination via urine.
- Executive summary:
In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route, but for worst case risk assessment, 100% absorption is proposed. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. This is further confirmed by the extensive metabolic studies conducted on the closely related substance lauramide DEA. Lauramide DEA, following absorption in rodents, is metabolized to the half-acid amides of succinic and of adipic acid. These metabolites would arise from the ω-hydroxylation and eventual β-oxidation to give the chain-shortened products. The metabolism studies conducted by Mathewset al. (1996) on the analogue demonstrate that the amide moiety is not hydrolysed; hence the lack of potential for amine formation. Since ω-hydroxylation and β- oxidation are the only noted means of metabolism (these are common metabolic pathways for dietary fatty acids and triglycerides), there is no possibility that reactive, or potentially mutagenic intermediates, can be formed. The metabolic data on the close structural analogue lauramide DEA corroborates the conclusion that the substance is not considered to be bioaccumulative, and would be metabolised for elimination via urine.
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