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EC number: 400-920-6 | CAS number: 89857-06-7
- 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
NOAEL (oral; sub-acute; rat) = 200 mg/kg bw/day
NOAEL (dermal; sub-acute; rat) = 1000 mg/kg bw/day
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 ng/kg bw/day
- Study duration:
- subacute
Additional information
The repeated oral toxicity of test item was assessed following OECD Guideline 407, Repeated Dose 28 -Day Oral Toxicity in Rodents.
Oral administration of test item to Wistar rats at doses of 50, 200 and 1000 mg/kg body weight/day for 28 days resulted in no deaths, no adverse test item-related clinical signs, no test item-related effects upon the parameters of the functional observational battery including grip strength, no changes in mean daily food consumption, no test item-related differences in hematology and clinical biochemistry and no macroscopic changes.
Test item related findings of toxicological relevance were generally restricted to: Lower body weight gains in males treated with 200 mg/kg/day (15th day of treatment) and males and females treated with 1000 mg/kg/day (males: 8th and 15th day of treatment and during recovery, females: 8th day of treatment), elevated erythrocyte and leucocyte counts in the urine of males and females treated with 200 and 1000 mg/kg/day, increased kidneyto-body weight ratios in males and females treated with 1000 mg/kg/day and males treated with 200 mg/kg/day and, microscopically, tubular cell damage in males and females treated with 1000 mg/kg/day (tubular cell necrosis in males and tubular basophilia in females).
The increased erythrocyte and leucocyte counts in the urine were considered to be a consequence of renal cell damage and the tubular basophilia can be understood as sequel to tubular damage.
Based on the results of this study, 200 mg/kg body weigh/day of test item was established as the no-observed-adverse-effect-level
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.9 Specific target organ toxicity - repeated exposure section, substances are classified as specific target organ toxicants following repeated exposure by the use of expert judgement, on the basis of the weight of all evidence available, including the use of recommended guidance values which take into account the duration of exposure and the dose/concentration which produced the effect(s), and are placed in one of two categories, depending upon the nature and severity of the effect(s) observed.
Classification in Category 1 is applicable, when significant toxic effects observed in a 90-day repeated-dose study conducted in experimental animals are seen to occur at or below the guidance values:
- oral (rat): (C) ≤10 mg/kg bw/day
Classification in Category 2 is applicable, when significant toxic effects observed in a 90-day repeated-dose study conducted in experimental animals are seen to occur within the guidance value ranges as:
- oral (rat): 10 < C ≤ 100 mg/kg bw/day
For a 28-day study the guidance values above mentioned are increased by a factor of three.
Two repeated dose toxicity studies are available on the the test substance.
In a sub-acute dermal repeated dose toxicity study the NOAEL was found to be 1000 mg/kg bw/day, thus no classification for the test substance is proposed according to this study.
In a sub-acute oral repeated dose toxicity study the NOAEL was found to be 200 mg/kg bw/day. Test-item related findings of toxicological relevance were related to elevated erythrocyte and leucocyte counts in the urine of males and females treated with 200 and 1000 mg/kg/day, increased kidney-to-body weight ratios in males and females treated with 1000 mg/kg/day and males treated with 200 mg/kg/day. Further treatment-related findings were judged as non adverse and consisted of increased incidence and severity of hyaline droplets in the kidneys of male animals in all treated groups, tubular cell swelling in a single male treated with 1000 mg/kglday and in females treated with 200 (one single animal) and 1000 mg/kg/day.
The occurrence of hyaline droplets was considered to be a typical male rat specific effect and is not considered relevant for human. Furthermore no test item-related differences were noted in the mean absolute or relative organ weights after 2 weeks' recovery. The effects at 1000 mg/kg bw/day all are recovered except the erythrocyte count in the urine of females treated with the highest test dose concentration. So even at concentrations around 300 mg/kg bw/day all effects are expected to be recovered as per 200 mg/kg bw/day, thus no classification for the test substance is proposed.
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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