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EC number: 700-055-7 | CAS number: 630113-05-2
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Short description of key information on bioaccumulation potential result:
The physico-chemical characteristics of the substance and the absence of significant adverse effects observed in the toxicological studies tend to indicate a limited absorption and a low biodisponibility.
Short description of key information on absorption rate:
Based on physico-chemical properties (MW: 537 ; LogKow <-1.98, high water solubility, poor lipophilicity) and the presence of quaternary ammonium fucntions, the substance is unlikely to be well absorbed by the dermal route.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 100
Additional information
There are no experimental data. A preliminary assessment was made based on the information currently available from the dataset.
Based on the physico-chemical properties, such as molecular weight and logKow, the substance is considered to have a low bioavailability potential by all routes. This is further supported by the low toxicity profile observed in the various studies available.
The substance meets the criteria that allows the use a default value of 10% for dermal absorption for risk assessment purposes (REACH Guidance document, R7.12, EC Guidance document on dermal absorption SANCO 222/2000, 2004).
Discussion on bioaccumulation potential result:
There are currently no experimental toxicokinetics study. The assessment was based on the available dataset.
There was no observation available from the repeated dose toxicity studies providing specific information on potential absorption, metabolisation, distribution and excretion of the substance or metabolites.
However, based on the data currently available in the dataset, both from the physico-chenical properties (molecular weight, LogKow, vapour pressure, structure, ionic charge) and toxicological data, the substance is considered to present a low systemic bioavailability by all routes. This is further supported by the low toxicity profile observed.
Discussion on absorption rate:
ABSORPTION
No substance-specific absorption data were available experimentally by any route.
1)Skin absorption
Skin permeability estimates:
Input parameters:
MW = 537
log Kow = -1.98
Based on the log Kow a poor lipophilicity is predicted. The MW above 500 is also not in favour of dermal absorption.
As estimate of the permeability coefficient (maximum flux across the skin) was conducted using various mathematical models:
> Potts & Guy : logKp = 0.71logKow – 0.0061MW – 2.72
Kp = 3.96 10-8 cm/h
sources :
- Potts & Guy (1992).Pharm.Res. 9:6693-669
- www.cdc.gov/niosh/topics/skin/skinpermcalc.html
> Frasch: Kp = 4.96 10-10 cm/h
source :www.cdc.gov/niosh/topics/skin/skinpermcalc.html
> Modified Robinson : Kp = 6.77 10-6 cm/h
source :www.cdc.gov/niosh/topics/skin/skinpermcalc.html
> SkinPerm : Kp = 8.83 10-7cm/h
source :http://home.planet.nl/~wtberge/qsarperm.html
The various mathematical models based on hydrophobicity properties and molecular weight provided Kp estimates ranging from 8.83 10-7(SkinPerm) to 4.96 10-10(Frasch). These figures are all below 10-6 and support a very low percutaneous absorption capacity (Howes et al., 1996. Methods for assessing percutaneous absorption. The report and recommendations of ECVAM Workshop 13. ATLA 24:81-106).
Other considerations:
The molecular weight of 537Dalton, and the presence of cationic charged functions are not in favour of a passive diffusion accross biological membranes. (H. Schaefer, T. E. Redelmeier (eds), 1996.In: Skin Barrier – Principles of percutaneous absorption.S. Krager AG (publ.))
Furthermore, the acute dermal toxicity study at level up to 4840 mg/kg (dose expressed for the registered substance, with the residual stabilising water), i.e. 2000 mg/kg for the main TRIQUAT constituent, did not show any signs of systemic toxicity. No clinical signs were noted during the 15-day observation period.
No damages or alteration of the skin integrity are expected as the substance did not induce any signs of skin irritation in vivo.
It is generally admitted to consider a default skin absorption factor of 10% for substances with a molecular weight above 500 and a logKow below -1 (REACH guidance document, R.7.12; EC Guidance document on dermal absorption, SANCO/222/2000 rev7, 19 March 2004)
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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