Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-215-4 | 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
There were no studies available in which the toxicokinetic properties of the registered substance were investigated.
The registered substance is a liquid with a molecular weight around 188, it is soluble in water (12.04 g/L at 20°C) and is lipophilic (log Kow = 2.3).
The available evidence suggests that the substance is bioavailable via the oral and dermal routes. The substance is expected to be extensively metabolised and mainly excreted in urine.
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
In accordance with the section 8.1.1 of Annex VIII of Regulation (EC) No 1907/2006 (REACH), the toxicokinetic profile of the substance (i.e. absorption, distribution, metabolism and elimination) was derived from the relevant available information collated in the dossier. The physical chemical characteristics of the substance, the results obtained from acute, repeated-dose, and reproductive toxicity studies on the substance were used to predict its toxicokinetic behaviour.
Physico-chemical properties:
The substance is a multiconstituent, having a relatively low molecular weight around 188 g/mol. The substance is a water soluble liquid (12.04 g/L) and is slightly lipophilic based on the octanol/water partition coefficient (Log Kow = 2.3 at 35°C). The substance has moderate volatility according to its vapour pressure (583 Pa Pa at 20°C).
Absorption:
Oral/GI absorption
The physical chemical characteristics described above suggest that the substance could be absorbed in the gastro-intestinal tract by passive diffusion. Water-soluble substances would dissolve into the gastrointestinal fluids. There are no ionisable groups in the parent substance so pH would not affect absorption.
These hypotheses are supported by oral adaptative systemic effects observed in the combined toxicity study with the reproduction/developmental toxicity screening test performed on the registered substance in rats by dietary administration. After 6 weeks of treatment, the mean absolute and adjusted liver weights for males and females receiving 1500, 3500 or 8000 ppm were marginally high. After 2 weeks of recovery, the mean absolute and adjusted liver weights for males and females that previously received 8000 ppm were similar to Control. Dietary administration of the test item to rats for 6 weeks resulted in test item related findings in the kidneys of all treated males. Hyaline droplet accumulation can be seen as a background change in rat kidneys, but the incidence and severity of this change in males and the association with an increased severity of tubular basophilia and the presence of granular casts indicated that this change was related to treatment. Following a 14-day recovery period, full recovery from test item related findings seen in the kidneys was considered to have occurred.
The observation of slight systemic effects indicates the oral bioavailability of the registered substance and/or its metabolites.
In light of these data, and the lack of specific information on oral absorption, the substance was assumed to be 100% bioavailable by oral route for the purposes of human health risk assessment.
Dermal absorption
Regarding dermal absorption, systemic absorption by the dermal route is expected to occur based on the log Kow (between -1 and 4) and the low molecular weight (< 500 g/mol). The absence of effects in the actue toxicity study by dermal route probably indicates low toxicity rather than the absence of absorption.
Therefore, the substance was conservatively assumed to be 100% bioavailable by dermal route for the purposes of human health risk assessment.
Respiratory absorption
The potential for inhalation toxicity was not evaluated in vivo.
The vapour pressure of the substance (Vp = 583 Pa at 20°C) indicated a moderate volatility and inhalability and therefore exposure by inhalation may occur. Thus, at ambient temperature, respiratory absorption is expected under normal use and handling of the substance. Also, when used as a vapour or in aerosol, the substance is expected to be directly absorbed across the respiratory tract epithelium by passive diffusion.
In light of these data, and the lack of specific information on respiratory absorption, the substance was conservatively assumed to be 100% bioavailable by inhalation for the purposes of human health risk assessment.
Distribution:
There is no experimental evidence to indicate distribution but the physico-chemical data suggests that wide distribution could occur. The log Kow value of 2.3 at 35°C suggests that the substance would not extensively accumulate. Distribution and bioaccumulation are highly dependent on the rate of biotransformation and elimination. There is, however, no evidence of cumulative effects from the repeated dose oral toxicity study.
Metabolism:
All three in vitro genotoxicity tests showed some evidence of attenuation of cytotoxicity in the presence of S9 which may indicate biotransformation into less cytotoxic metabolites by microsomal enzymes.
Excretion:
The parent substance is water-soluble therefore elimination of the unchanged form, in urine, may be possible. Biotransformation is expected and elimination of metabolites would most likely occur in urine, although elimination of conjugates in bile is possible. As the parent substance is volatile, elimination via the lungs, in expired air could also be possible.
The registered substance has log Kow=2.3 at 35°C which is below the criterion of 4.5 for bioaccumulation and is believed to be extensively and rapidly metabolised; therefore, it is considered to have no bioaccumulation potential.
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.