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Diss Factsheets
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EC number: 701-135-4 | 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
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
ABSORPTION:
Oral absorption
Based on physicochemical properties and available data:
According to REACH guidance document R7. C, oral absorption is maximal for substances with molecular weights below 500; molecular weights above 1,000 do not favour absorption. Also, absorption by passive diffusion is higher at moderate log Kow vales (between -1 and 4) whereas uptake via micellar solubilisation may be important at log Kow values > 4. If signs of systemic toxicity are seen after oral administration (other than those indicative of discomfort or lack of palatability of the test substance), then absorption has occurred.
Based on these R7.C based indicative criteria, oral uptake of the test substance is assessed as moderate to high. The test substance is a mono constituent with MW of 302.4 g/mol, it is a liquid with a moderate water solubility (2.73 g/L) and low lipophilicity (with log Kow 0.467). The systemic availability of the substance via the oral route is demonstrated by a range of significant effects seen in acute oral and repeat dose studies, above dose levels of 300 mg/kg/d.
Conclusion: The oral uptake of the test substance is high, therefore the default value of 100% has been considered for risk assessment.
Dermal absorption
Based on physicochemical properties:
According to REACH guidance document R7.C (ECHA, 2017), dermal absorption is maximal for substances having a MW below 100 together with log Kow values ranging between 2 and 3 and water solubility in the range of 100-10,000 mg/L. Substances with MW above 500 are considered to be too large to penetrate skin. Further, dermal uptake is likely to be low for substances with log P values <-1, as they are not likely to be sufficiently lipophilic to cross the stratum corneum (SC). Similarly, substances with water solubility below 1 mg/L are also likely to have low dermal uptake, as the substances must be sufficiently soluble in water to partition from the SC into the epidermis.
The test substance is a liquid with a molecular weight of 302.4 g/mol, low to moderate water solubility (2.73 g/L at 20 oC) and a log Kow of 0.467 at 20 oC. this suggests the test substance is likely to have a low to moderate penetration potential through the skin. However, the test substance was found corrosive to skin when tested in an in vivo skin irritation/corrosivity study in rabbits. Therefore, dermal penetration may be enhanced due to damage to the skin.
Conclusion: Overall, based on all the physico-chemical information, the test substance can be expected to have a low to moderate absorption potential through the dermal route which may be enhanced due to the corrosive nature of the test substance. Therefore, a default value of 100% (in line with the ECHA Guidance Chapter R.8) has been considered for the risk assessment.
Inhalation absorption
Based on physicochemical properties:
According to REACH guidance document R7.C (ECHA, 2017), the vapour pressure indicates if the a substance is available for inhalation as a vapour and substances with low volatility have a vapour pressure of less than 0.5 kPa or a boiling point above 150 °C. The test substance has a vapour pressure of 1.0 x 10-2 Pa at 25 °C and will not be available as vapours for inhalation under ambient conditions. Should there be inhalation exposure during normal handling and use conditions, only coarse droplets would be potentially available for exposure, resulting in a very low respiratory fraction. Of the inhalable fraction, due to the moderate water solubility, the test substance could be retained in the mucus which would be transported to the pharynx and swallowed via the ciliary-mucosal escalator. The absorption potential of this fraction of the test substance can be considered to be similar to the oral route.
Conclusion: Based on the above information, if exposure occurs, the test substance can be expected to have low absorption through the inhalation route. However, given systemic toxicity is observed via the oral route, a conservative approach has been used for risk assessment and a default value of 100% (in line with the ECHA Guidance Chapter R.8) is used.
Metabolism
Currently no investigation regarding metabolism of test substance is available.
DISTRIBUTION
Per REACH guidance document R7.C (ECHA, 2017), the smaller the molecule, the wider the distribution. Small water-soluble molecules and ions will diffuse through aqueous channels and pores, although the rate of diffusion for very hydrophilic molecules will be limited. Further, if the molecule is lipophilic (log P >0), it is likely to distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues.
Given the molecular weight of the substance and moderate water solubility, as well as systemic toxicity seen on repeat dose studies, the test substance is assumed to be distributed throughout the body and could be distributed to highly perfused organs/tissues. However, no specific target organ effects were noted on acute or repeat dose studies.
The low log Kow (0.467) combined with the observation of very low levels of bioaccumulation demonstrated in fish exposed via the dietary route, suggests the potential for bioaccumulation is low.
Conclusion: Based on all the available weight of evidence information, the test substance is likely to be distributed if absorbed, but with a low bioaccumulation potential.
EXCRETION:
Based on physicochemical properties:
According to REACH guidance document R7.C (ECHA, 2017), the characteristics favourable for urinary excretion are low molecular weight (below 300 in the rat), good water solubility, and ionization of the molecule at the pH of urine (4.5 to 8).
The test substance has a molecular weight of just above 300 and may therefore be excreted via urine. Further, it has been found in the rat that substances with molecular weights around 300 do not tend to be excreted into the bile. There are species differences, and the exact nature of the substance also plays a role. Without further information on the metabolism of the test substance it must be assumed that both excretion via urine and faeces is possible.
Conclusion: Based on all the available weight of evidence information, the test substance is expected to be excreted via urine and faeces.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
Based on the available weight of evidence information, the test substance is expected to have a moderate absorption potential via the oral route as well as through the inhalation route; absorption potential through dermal route is not relevant given the corrosive properties of the substance.
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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