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Diss Factsheets
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EC number: 948-935-1 | 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
The toxicity of the substance has been assessed by the repeated exposure over a period of 28-days by the three routes of exposure, oral, dermal and inhalation using read across studies .
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- There are two Klimisch score 1 read across studies avaiable.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 49.5 mg/m³
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The read across study has a Klimisch score of 1.
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The NOEAL was selected from a Klimisch score 1 study. A lower quality study is also available.
Additional information
The repeat dose toxicity has been determined by subacute 28-day toxicity studies by oral, dermal and inhalation exposure. Based on the data available, the substance may have the potential for haemotological effects with a reduction in cholesterol observed in one of the studies by oral exposure. Affects observed in the repeat dose inhalation toxicity study available demonstrated enlarged lungs in high and intermediate dose animals which are likely to be physical effects due to the inhalation of mineral oil and not necessarily a direct toxicological effect of the registered substance.
Furthermore, one dermal repeat dose study exists noting effects which resulted in the Study Director being unable to assign a NOAEL. Due consideration of these data has been taken, but the results are considered not representative of the toxicological effects of the substance since the observations have not been repeated in the remaining study with dermal exposure, nor following exposure by oral and inhalation routes which are generally considered to represent greater systemic exposure routes. Furthermore, effects to the testes of male rats were not been observed in the reproductive toxicity study. In consequence, although data are not available to adequately determine the cause of these effects, the fact that no similar observations have been found in any other study undertaken is considered adequate justification to regard these data as not representative of the toxicological profile of the registered substance.
Notwithstanding these effects, no further effects were observed in the studies and each study achieved a NOAEL. The data are therefore considered adequate to assess the toxicological profile of the substance and for the purposes of classification.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The NOAEL was selected from the most conservative value of the two available read-across studies.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
There is only one read across study available.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Any local effects will be covered in the NOAEL for systemic effects.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
The NOAEL was selected from the higher quality subacute dermal study.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
All local effects will be covered in the NOAEL for systemic effects.
Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: other
Repeated dose toxicity: inhalation - systemic effects (target organ) respiratory: lung
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for repeated dose 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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