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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
- Type of information:
- other: expert statement
- Adequacy of study:
- key study
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Theoretical assessment taking all currrently available relevant (phys-chem) information into account, based on the REACH Guidance: Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7c Endpoint specific guidance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance for the implementation of REACH. Guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific guidance. European Chemical Agency, May 2008
- Deviations:
- not applicable
- GLP compliance:
- no
Test material
- Details on test material:
- - Composition of test material, percentage of components: see section confidential details on test material
Constituent 1
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- For risk assessment purposes, 50% is used for oral and dermal absorption and 100% is used for inhalation absorption
Any other information on results incl. tables
TOXICOKINETIC ASSESSMENT
A substance can be absorbed via the gastro-intestinal tract, respiratory tract or the skin. An assessment of toxicokinetic parameters and specifically absorption is made here based on physicochemical parameters of the test substance (surfactant fraction only).
In general, a substance needs to be dissolved before it can be taken up from the gastro-intestinal tract (1). The critical micelle concentration (CMC) of C8-18 alkylampho(di)propionate can be seen as an indication of the water solubility and hydrophilicity of the test substance. The moderate CMC of 131 mg solids/L indicates that this substance will dissolve in water, and to some extent in lipophilic environments. In addition, as the substance is manufactured as an aqueous solution at ca. 38.5% solid content, it is expected to dissolve in the gastro-intestinal fluid. The molecular weight of the main constituents (380 - 474 g/mol) of C8-18 alkylampho(di)propionate also favours absorption. The low partition coefficient octanol/water (−2.31) discourages passive diffusion. The presence of an ionisable group (or groups) may impair the absorption as ionised substances do not easily pass the gastro-intestinal wall. C8-18 alkylampho(di)propionate has weak surface-active properties, as shown by the surface tension of 36-39.5 mN/m. Based on this, local disruption of cell membranes is expected to be minimal, which is confirmed by the absence of local effects in the studies performed.
Based on the available physical/chemical properties of C8-18 alkylampho(di)propionate, for risk assessment purposes the oral absorption of C8-18 alkylampho(di)propionate is set at 50%. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption factor.
Once absorbed in the gastro-intestinal tract, C8-18 alkylampho(di)propionate might be metabolized (3). Excretion of C8-18 alkylampho(di)propionate and its metabolites will occur via the bile (high molecular weight) or the urine (low molecular weight). Based on the log partition coefficient of −2.31, C8-18 alkylampho(di)propionate is not expected to accumulate in adipose tissue (2).
The low vapour pressure (< 5.8 x 10-3 Pa) indicates that it is not likely that C8-18 alkylampho(di)propionate will reach the nasopharyncheal region or subsequently the tracheo/bronchial/pulmonary region by inhalation of vapour. However, if C8-18 alkylampho(di)propionate reaches the tracheobronchial region, C8-18 alkylampho(di)propionate dissolves within the mucus as indicated by its favourable water solubility. The low log Pow (−2.31) is less favourable for absorption directly across the respiratory tract epithelium by passive diffusion. Therefore, for risk assessment purposes the inhalation absorption of C8-18 alkylampho(di)propionate is set at 100%.
The molecular weight of 380-474 g/mol and the moderate to high water solubility are in favour of dermal absorption. The low log Pow disfavours dermal absorption. The substance has weak surface active properties, but is not expected to damage the skin (only slight erythema observed
- reversible within 48 hours - in skin irritation studies). According to the criteria given in the REACH Guidance (2), 10% dermal absorption will be considered in case MW >500 and log Pow <-1 or >4, otherwise 100% dermal absorption should be used. As the physical/chemical properties of C8-18 alkylampho(di)propionate do not meet the criteria for limited dermal absorption, for risk assessment purposes dermal absorption should be set at 100%. However, as it is generally accepted that dermal absorption does not exceed oral absorption, 50% dermal absorption is considered to be a more realistic dermal absorption factor. The results of the toxicity studies do not provide reasons to deviate from this proposed dermal absorption factor.
References:
(1) Martinez MN, Amidon GL. Mechanistic approach to understanding the factors affecting drug absorption: a review of fundamentals. J Clin Pharmacol 2002; 42: 620-43.
(2) Guidance for the implementation of REACH. Guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific guidance. European Chemical Agency, May 2008.
(3) A. Parkinson. In: Casarett and Doull’s Toxicology, The basic science of poisons. Sixth edition. Ed. C.D. Klaassen. Chapter 6: Biotransformation of xenobiotics. McGraw-Hill, New York, 2001.Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: the substance is not expected to accumulate
Using a theoretical approach based on the available physico-chemical properties and toxicological data, the following absorption factors were derived for risk assessment purposes: oral absorption factor: 50%; dermal absorption factor: 50%; inhalation absorption factor: 100%
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.
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