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Diss Factsheets
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EC number: 264-867-9 | CAS number: 64396-12-9
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)
- Justification for type of information:
- The substance dissociates under biological conditions when dilute forming alkyl succinic acid and triethanolamine
A toxicity assessment has been made on the dissociation products and these are not classified as hazardous.
Dermal penetration on triethanolamine suggests very low rate or dermal penetration (< 2%) and review of metabolic profile demonstrates rapid metabolic breakdown and elimination
No further animal testign can be justifed.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Taken from international safety assessment report for cosmetic use of triethanolamine
Triethanolamine is one of the products of dissociation - Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Principles of method if other than guideline:
- Use of human skin in-vitro.
Triethanolamine emulsions used in the presence of stearic acid. - GLP compliance:
- no
- Radiolabelling:
- no
- Species:
- other: Human
- Sex:
- not specified
- Type of coverage:
- other: Direct contact. In-vitro (ex-vivo)
- Vehicle:
- other: Emulsion of stearic acid in water
- Duration of exposure:
- Up to 72 hours
- Doses:
- Up to 5% in emulsion
- Absorption in different matrices:
- Absorption into skin of up to 20.9 % at pH8
Absorption into media (through skin) up to 1.2% at pH 8
(Note absorption into skin and through skin was reduced at pH 7) - Key result
- Time point:
- 72 h
- Dose:
- 5 % emulsion
- Parameter:
- percentage
- Absorption:
- ca. 20 %
- Remarks on result:
- other: pH8
- Remarks:
- Into skin
- Key result
- Time point:
- 72 h
- Dose:
- 5% emulsion
- Parameter:
- percentage
- Absorption:
- ca. 1.2 %
- Remarks on result:
- other: pH8
- Remarks:
- Through skin
- Conclusions:
- Triethanolamine is present in the substance and is a product of dissociation.
This has been well evaluated for safety in cosmetics including dermal penetration testing.
Only a small fraction of the substance appears to penetrate the skin.
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Assessment
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- Review of toxicological and chemical data, including products of dissociation
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Review of toxicological and chemical data, including products of dissociation
- GLP compliance:
- no
- Radiolabelling:
- no
- Details on absorption:
- In view of the absence of apparent toxic effects, there is no direct evidence that the dissociation products will absorb if ingested.
In an in-vivo study, triethanolamine was rapidly absorbed in the gastrointestinal tract and
excreted mostly unchanged in urine.
Work on the smaller and more polar of the starting materials (triethanolamine) has demonstrated very low rates of absorption through skin and both succinic acid and triethanolamine products are widely accepted for use in cosmetics. - Details on distribution in tissues:
- If absorbed, it is likely that there is distribution, although no target organ was identified.
- Test no.:
- #1
- Observation:
- not determined
- Details on excretion:
- In view of the potential to metabolise, perhaps leading to mineralisation (water, urea and carbon dioxide).
In an in-vivo study, triethanolamine was rapidly absorbed in the gastrointestinal tract and
excreted mostly unchanged in urine. - Metabolites identified:
- no
- Details on metabolites:
- Succinic acid and ethanolamine derivatives are rapidly metabolised or excreted. These types of chemical substances occur in nature and are themselves products of metabolic processes and will in turn metabolise further.
The potential to metabolise is confirmed by the high levels of biodegradation.
None of the starting materials or potential metabolites are considered to have any accumulation potential. - Conclusions:
- The substance will dissociate and the alkly succinate and triethanolamine derivatives wil rapidly metabolise or be extreted.
The substance is not considered accumualtive.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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