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EC number: 300-339-7 | CAS number: 93925-37-2
- 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
Description of key information
Oral administration of the test item to rats for a period of forty-two days for males and up to fifty-four days for females at dose levels of up to 1000 mg/kg/day resulted in treatment-related effects in males treated with 1000 and 350 mg/kg/day. No toxicologically significant effects were detected in females from any treatment groups. No clinically observable signs of toxicity were observed during the daily clinical observations and no toxicologically significant effects were observed during the weekly open field arena observations, the haematological parameters, or the blood chemical parameters. The effects detected in this study were considered not to represent an adverse health effect, therefore a NOAEL and a suitable high dose level for use on a twenty-eight day study was considered to be 1000 mg/kg/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Oral administration of the test item to rats for a period of forty-two days for males and up to fifty-four days for females at dose levels of up to 1000 mg/kg/day resulted in treatment-related effects in males treated with 1000 and 350 mg/kg/day. No toxicologically significant effects were detected in females from any treatment groups. No clinically observable signs of toxicity were observed during the daily clinical observations and no toxicologically significant effects were observed during the weekly open field arena observations, the haematological parameters, or the blood chemical parameters.
Macroscopic findings did not reveal any effects considered to be attributable to treatment. Organ weight data however revealed increases in absolute and relative liver and kidney weight for males treated with 1000 and 350 mg/kg/day and microscopic examinations revealed treatment related effects in the liver and kidney for males treated with 1000 mg/kg/day. Centrilobular hepatocyte enlargement was evident however this is commonly observed in the rodent liver following the administration of xenobiotics and, in the absence of associated inflammatory or degenerative changes, is generally considered to be adaptive in nature.
A higher incidence of
globular accumulations of eosinophilic material in the tubular
epithelium was also detected. Accumulations of globular eosinophilic
material in the tubular epithelium is a well documented effect and are
peculiar to the male rat, which occurs in response to treatment with
certain hydrocarbons. Female rats and other species do not develop
“hydrocarbon nephropathy” and for this reason, the effect is not
indicative of a hazard to human health.
Centrilobular hepatocyte enlargement was seen in relation to treatment
for males only treated with 1000 mg/kg/day. Hepatocyte enlargement is
commonly observed in the rodent liver following the administration of
xenobiotics and, in the absence of associated inflammatory or
degenerative changes, is generally considered to be adaptive in nature.
The effects detected in this study were considered not to represent an adverse health effect, therefore a NOAEL and a suitable high dose level for use on a twenty-eight day study was considered to be 1000 mg/kg/day.
Justification for classification or non-classification
There are conclusive and sufficient data for classification of the substance with regard to repeated dose toxicity.
The test item is not classified for this endpoint in accordance to Directive 67/548/EEC or to the CLP Regulation (EC) No 1272/2008.
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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