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EC number: 241-629-2 | CAS number: 17647-86-8
- 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
Based on physico-chemical characteristics, particularly water solubility and octanol-water partition coefficient (Pow) absorption via oral route is likely to occur. Dermal uptake will be limited due to the hydrophilic character of the test substance and the barrier function of the stratum corneum against ions. Based on the low vapour pressure of the compound, absorption via inhalation route is also unlikely to happen. Once absorbed, distribution in fatty tissues and bioaccumulation is unlikely. Due to the high water solubility, metabolic conversation is unlikely and excretion via urine is assumed to be the main excretion pathway.
Key value for chemical safety assessment
Additional information
General background and toxicological
profile of Glycine, N,N-dimethyl-, potassium salt
Glycine, N,N-dimethyl-, potassium
salt is a white salt with the formula C4H8KNO2.
The acute oral LD50 of the test substance (45% solution) after single
oral administration to Wistar rats is > 5000 mg/kg bw/day (BASF 1979,
78/498). The observed LD50 after dermal application on the clipped skin
of Wistar rats is > 2000 mg/kg bw/day and no macroscopic pathological
abnormalities were noted (BASF 2015, 11A0456/01X069).
The results of two skin irritation studies (BASF 1979, 78/498) showed that the test substance is not irritating to the intact skin of Vienna White rabbits after 4 h. With the Draize test, the substance is slightly irritating to the intact skin of Vienna White rabbits. The results of an eye irritation study (BASF 1979, 78/498) demonstrated, that the test compound needs to be considered as irritating to the eye of Vienne White rabbits and was classified as eye damaging, cat.1.
Skin sensitization was not observed in an LLNA test in mice (OECD 429; BASF 2015, 58V0456/01X070).In a repeated-dose oral toxicity study in rats, following OECD 422, the test substance was administered daily as solutions to groups of 20 Wistar rats (10/sex) via drinking water. Under the conditions of this test, the oral administration via drinking water of the test substance to rats revealed no signs of general systemic toxicity in male and female parental animals up to a concentration of 12000 ppm (731 mg/kg bw/day in males and 960 mg/kg bw/day in females). Further, no signs of reproductive or developmental toxicity were observed. Thus, the NOAEL for general systemic toxicity and reproductive performance and fertility was 12000 ppm in male and female parental animals (731 mg/kg bw/day in males and 960 mg/kg bw/day in females). The NOAEL for developmental toxicity in the F1 progeny was also 12000 ppm.
The genetic toxicity of the test substance was investigated in a bacterial reverse mutation assay (OECD 471; BASF 2015, 40M0456/01M019), HPRT assay (OECD 476; BASF 2015, 50M0456/01M022) and a Micronucleus assay (OECD 487; BASF 2016, 33M0456/01M020). All tests were considered negative with and without metabolic activation and no genetic toxicity of the test substance was observed.
Toxicokinetic assessment of Glycine, N,N-dimethyl-, potassium salt
The test substance is a white powder at room
temperature with a molecular weight of 141.2101 g/mol and a density of
1.374 g/cm³ at 20 °C. The melting point of the substance is in the range
between 193 and 232 °C and a vapour pressure of < 1*10^-6 hPa at 20 °C,
25 °C and 50 °C was determined. The substance is easily soluble in water
as indicated by the measured water solubility value of 910 g/L at 20 °C.
The experimentally determined partition coefficient between octanol and
water (log Pow) value of -2.91 is very low.
Absorption
Oral route
Following oral administration, the
likelihood of systemic absorption through the walls of the intestinal
tract depends on several physicochemical substance properties. In order
to obtain a conclusive judgement of a substance’s potential to be able
to reach the systemic circulation, important physicochemical factors
such as molecular weight, water solubility and the log Pow need to be
considered. According to ECHA Guidance Document R.7c, the smaller the
molecule the more easily it gets through the walls of the
gastrointestinal tract (GI). Molecular weights below 500, like the
molecular weight of the test substance, are favourable for absorption.
In addition, the very low log Pow indicates that the test substance is
very hydrophilic and the high water solubility facilitates the
absorption of such a substance due to its ability to dissolve into the
GI fluids and hence make contact with the mucosal surface. In addition,
the very low log Pow indicates that the substance is very hydrophilic
and the high water solubility facilitates the absorption of such a
substance due to its ability to dissolve into the GI fluids and hence
make contact with the mucosal surface. Thus, passive diffusion of the
substance is possible due to its hydrophilic nature, but is limited by
the rate at which the substance partitions out of the gastrointestinal
fluid. However, substances with small molecular weights (less than 200)
may pass through aqueous pores or be carried through the epithelial
barrier by the bulk passage of water. With regard to the toxicological
data, no signs of systemic toxicity were observed in the acute oral
acute toxicity study (BASF 1979, 78/498) as well as in the repeated-dose
study (BASF 2016, 88R0456/01C029).
Inhalation route
The test substance has a low volatility
potential due to its very low vapour pressure of 0.000001 hPa. Thus,
inhalation as a vapour is very unlikely. However, absorption via
inhalation as dust might be possible. Due to the high water solubility,
dusts would readily dissolve into the mucus lining the respiratory
tract. Such substances may be transported out of the deposition region
with the mucus and swallowed or may pass the respiratory ephithelium via
aqueous membrane pores. Thus, uptake of high amounts directly across the
respiratory tract epithelium is not expected. No information from acute
or repeated dose toxicity studies is available, which could provide
information about the systemic distribution of the test substance after
inhalation.
Dermal route
To assess the potential of a substance to
cross the skin, basic physicochemical properties of the substance, i.e.
molecular weight, water solubility and lipophilicity (log Pow), should
be taken into account. The test substance has a very low molecular
weight which favours the dermal uptake. Nevertheless, dermal uptake of
the substance is expected to be low due to its hydrophilic properties
and the barrier function of the stratum corneum against ions. With a
water solubility above 10,000 mg/L and a log Pow value below 0 the
substance may be too hydrophilic to cross the lipid rich environment of
the stratum corneum. This assumption is supported by the toxicological
data achieved by a skin sensitization study (BASF 2015, 58V0456/01X070)
and two acute dermal toxicity studies (BASF 1979, 78/498). The studies
did not reveal that relevant amounts were absorbed into the systemic
circulation as no systemic effects were observed. Based on the findings
on the intact skin, the test substance is not considered as a skin
irritant with respect to edema or erythema but is considered as a slightly
skin irritant only due to skin scales formation (not relevant for classification
purposes). The latter does not enhance skin penetration.
Distribution
As mentioned above, the physicochemical
properties and toxicological data revealed that the test substance can
become systemically available following oral exposure. Once absorbed,
the distribution of the test substance via blood stream can be assumed.
The small molecular weight of the substance supports a wide
distribution. Due to its high water solubility and very low Pow value
distribution in fatty tissues is unlikely. In general, the transport
efficiency to body tissues is limited by the rate at which the test
substances cross cell membranes. For instance, access of highly water
soluble substances to the central nervous system (CNS) or testes is
likely to be restricted by the blood-brain and blood-testes barriers
(Rozman and Klaasen, 1996).
Metabolism
Biotransformation of a substance aimed to
increase the hydrophilicity of lipophilic substances by Phase I
(functionalization) and Phase II (conjugation) enzymes. Due to the high
water solubility of the test substance, metabolic conversion is
unlikely. In addition, based on the results of the Ames test (BASF 2015,
40M0456/01M019), Chromosome Aberration test (BASF 2016, 33M0456/01M020)
and HPRT test (BASF 2015, 50M0456/01M022) it can be assumed that the
test substance is not enzymatically activated (toxified) during the
metabolism as the parent compound showed no higher toxicity compared to
the metabolic activated substance.
Excretion
Excretion can occur via the urine especially for small (below 300 g/mol) and water-soluble substance and/or via biliary excretion predominantly for larger molecules. Based on the high water solubility and the low molecular weight of the test substance, excretion might occur primarily via urine.
Summary
Based on the physicochemical properties particularly molecular weight, water solubility and log Pow, absorption via the gastrointestinal tract is likely. Uptake of relevant amounts following dermal exposure most likely does not occur due to its very high water solubility and its very low log Pow. Based on its low vapour pressure it is unlikely that the test substance will become systemically available after inhalation of vapour. After absorption, the test substance will circulate within the blood stream. Bioaccumulation is not to be expected based on the high water solubility and low partitioning coefficient. Due to the high water solubility, metabolic conversation is unlikely and excretion via urine is assumed to be the main excretion pathway.
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