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Diss Factsheets
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EC number: 476-900-6 | 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
Subacute toxicity after repeated oral exposure (feeding) was evaluated on the basis of a 28-day (feeding) study according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) in rats (Wistar rats; male/female) with daily exposure of the test substance registered. Furthermore, in a two-generation study performed in rats with the analogue substance 2 (refer to IUCLID chapter 13) the low toxicity after prolonged treatment is demonstrated. In this study the F0 parents were treated from 70 days before mating until euthanasia. ( for study summary refer to IUCLID chapter 7.8.1)
No repeated dermal toxicity test was performed with the test substance registered.
No repeated inhalation toxicity test was performed with the test substance registered.
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
Subacute toxicity after repeated oral exposure (feeding) was evaluated on the basis of a 28-day (feeding) study according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) in rats (Wistar rats; male/female) with daily exposure of the test substance registered. Five animals per sex and dose were tested. The dose ranges tested were 0, 50, 200 and 1000 mg/kg bw/day (nominal in diet). Concentration, homogeneity and stability of test item in the feed were determined. The 28 day treatment resulted in no test item related deaths, no clear test item related clinical signs during daily or weekly observations, no test item related findings during functional observation battery, no differences in mean daily food consumption or mean bodyweights upon mean absolute or relative organ weights, no macroscopical and no microscopical findings. The target dose levels were largely attained.
In a two-generation study performed with an analogue substance 2 (refer to IUCLID chapter 13) the F0 parents were treated from 70 days before mating until euthanasia at doses of 0, 100, 300 and 1000 mg/kg bw/day. The only test substance related effect noted was an increase in kidney weight without clear microscopic evidence effect at 300mg/kg bw/day ((P) females) and 1000 mg/kg bw/day (P and F1 males and females).
No repeated dermal toxicity test was performed with the test substance registered. The test material registered is of high molecular weight. It is used exclusively in aqueous solutions. Therefore, a significant skin penetration (bioavailability) and adverse effects via dermal exposure are not expected. An acute dermal toxicity test was performed as limit test resulting in an LD50 greater 2000 mg/kg bw. No systemic or local signs of toxicity were observed during the study.
No repeated inhalation toxicity test was performed with the test substance registered. The test material is produced and handled in industry exclusively in aqueous solutions. There are no spraying operations. Thus neither exposure nor risks are expected via the inhalation route.
The missing of any adverse findings in the 28-day repeated dose (feeding) study performed with the test substance registered up to the highest dose tested (i.e. 1000 mg/kg bw/day) and minimal findings in a two-generation study with an analogue substance 2 (refer to IUCLID chapter 13) in the mid and high dose, i.e. unspecific increase in kidney weight at 300mg/kg bw/day (P) females and 1000 mg/kg bw/day (P and F1 males and females)without clear microscopic evidence effect, provides indication that the toxic potential after prolonged treatment is low.
Justification for classification or non-classification
The missing of any adverse findings in the 28-day repeated dose (feeding) study performed with the test substance registered up to the highest dose tested (i.e. 1000 mg/kg bw/day) and minimal findings in a two-generation study with an analogue substance 2 (refer to IUCLID chapter 13) in the mid and high dose, provides indication that the toxic potential after prolonged treatment is low. Classification is not indicated.
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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