Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 866-700-0 | CAS number: 2102522-55-2
- 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
INTRODUCTION
In accordance with the Section 8.8.1 of Annex VIII in Regulation (EC) No 1272/2008, the toxicokinetic profile of the substance was derived from all available substance-specific information as collated in the registration dossier. The assessment is based on the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, 2017).
PHYSICOCHEMICAL PROPERTIES
The substance is a mono-constituent substance with a molecular weight of 382.43 g/mol.It is hydrolytically stable under the physiological condition.It is an off-white powder with no boiling point (test item changes at about 265°C), a melting point of 173.4 °C to 175.6 °C, and a vapour pressure of < 1.68 x 10-5Pa (25°C). The registered substance has a low water solubility of 0.0269 mg/L at 20°C and a log Pow of 2.7 (25°C).Due to its low water solubility, the oral and dermal absorptions of the registered substance is expected to be limited. The particle size results of the registered substance are: D10 = 7.12 µm, D50 = 21.8 µm, and D90 = 81.5 µm, which suggests its dust contents of respirable particles are considered to be limited .Its low vapour pressure value suggests that the substance is poorly available as a vapour.
ABSORPTION
No signs of oral absorption were seen in the results from the acute oral toxicity study in rats (Appl, 2017) and the combined repeated dose oral toxicity with reproduction/ developmental toxicity in rats (Fujii, 2021).
There are no signs of absorption via the dermal route in the acute dermal toxicity study in rats (Tsubokura, 2018) or the Local Lymph Node Assay in mice for skin sensitisation (Oroszlany, 2017).The registered substance is not a skin or eye irritantin vitro. Therefore, there is no indication to suggest that the dermal absorption may be enhanced by a repeated dosing regimen.
There were no signs of absorption following inhalation of the test item in rats (Nagy, 2021).
The available information suggests no signs of absorption via the oral, dermal and inhalation routes. However, in the absence of route-specific toxicokinetic information, and the relevant physico-chem data are within the range, a default value of 100% absorption rate is assumed for the oral, dermal and inhalation routes for risk assessment.
DISTRIBUTION
The moderate molecular weight and low water solubility of the registered substance are considered unlikely to allow it to disperse into the water compartment of blood for systemic distribution.There is no evidence to suggest the registered substance is distributed systemically or accumulated in the body in the available mammalian studies.
METABOLISM
The results of the OECD 422 study in rats did not show any evidence of enhanced liver metabolism up to the highest dose level of 1000 mg/kg bw/day. The substance was positive in the presence of metabolic activation in the chromosome aberration test using Chinese hamster lung fibroblasts, whereas it was negative without metabolic activation (Ogura, 2020). However, genotoxicity potential of TG_MD was not supported in other studies. It was negative in the Ames test both in the presence and absence of metabolic activation (Sarada, 2018) and in thein vivo micronucleus test in mice (Sakakibara, 2021). Overall conclusion was that metabolism did not influence genotoxicity.
EXCERETION
There is no evidence to indicate the route of excretion. Given its moderate molecular weight and log Pow value, the registered substance may preferentially go through biliary excretion. Any test material that is not absorbed will be excreted in the 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
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.