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Diss Factsheets
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EC number: 482-100-8 | 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
Description of key information
In acute oral and dermal toxicity studies in the rat, the LD50 was determined to be greater than 2000 mg/kg bodyweight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Read-across to properties of an analog is applicable based on the similarity in structure and physico-chemical properties. The justification for read-across is presented in Section 13 Assessment reports- Read-across justification.
Oral
The acute oral toxicity of this substance was evaluated in rats using the OECD 420 fixed dose method. Following acclimation, a sighting test at a dose level of 2000 mg/kg via gavage was conducted with one animal. Based on the absence of mortality, an additional four fasted female animals were given a single oral gavage dose of test material, as a solution in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. No mortality, clinical signs of systemic toxicity, body weight effects, or abnormal necropsy findings were observed.
Inhalation
According to REACH Annex XIII Section 8.5 information on acute toxicity will be provided for at least one other route in addition to the oral route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The substance is a solid with a vapour pressure of 0.012 Pa at 25°C and is used primarily as a component of lubricants and greases by workers and consumers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route. Testing for acute toxicity via the inhalation route is, therefore, not required.
Dermal
In a Guideline study performed to OECD 402 and EC Method B3 on an analogue substance, a single dose of 2g/kg undiluted test material was applied to the shaved back and flanks of ten rats (5 males and 5 females). The test material was covered with a semi-occlusive dressing for a period of 24 hours. At the end of the exposure period, the treated area was wiped gently with cotton wool moistened with distilled water to remove any residual test material. The animals were observed for deaths or overt signs of toxicity daily for 14 days. The test sites were also examined for evidence of primary irritation and scored according to the Draize scale daily for 14 days. Individual bodyweights were recorded prior to application of the test material at the start of the study and on days 7 and 14.
No mortality, clinical signs of systemic toxicity, body weight effects, or abnormal necropsy findings were observed.
The test article, when administered as received to male and female Sprague-Dawley rats, had an acute dermal LD50 of greater than 2000 mg/kg bodyweight
Based on the results of this study, this substance does not require classification under EU Regulation (EC) No. 1272/2008 for acute toxicity.
Justification for classification or non-classification
The acute toxicity of this substance was evaluated in rats using the OECD 420 fixed dose method for oral toxicity and OECD 402 for dermal toxicity . Based on the results of these studies, this substance does not require classification under EU Regulation (EC) No. 1272/2008 for acute toxicity.
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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