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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Based on investigations on sex organs and sperm staging in a subacute repeated dose study performed according to current guidleines and GLP
Additional information
In a 28 -day oral gavage study in rats receiving up to 1000 mg/kg bw of the test item per day for 28 consecutive days, no effects on male and female sex organs was observed. The study included an an extended histopatholgy of the male sex organs including sperm staging .No test substance related effects on the sex organs up to the highest dose tested were observed. This indicates that on a screening level there is no immediate concern for possible effects on fertility.
Short description of key information:
In a 28 -day oral gavage study in rats receiving up to 1000 mg/kg bw of the test item per day for 28 consecutive days, no effects on male and female sex organs was observed. The study included an an extended histopatholgy of the male sex organs including sperm staging .No test substance related effects on the sex organs up to the highest dose tested were observed. This indicates that on a screening level there is no immediate concern for possible effects on fertility.
Justification for selection of Effect on fertility via oral route:
In a 28 -day oral gavage study in rats receiving up to 1000 mg/kg bw of the test item per day for 28 consecutive days, no effects on male and female sex organs was observed. The study included an an extended histopatholgy of the male sex organs including sperm staging .No test substance related effects on the sex organs up to the highest dose tested were observed. This indicates that on a screening level there is no immediate concern for possible effects on fertility.
Effects on developmental toxicity
Description of key information
No effects on prenatal embryo-fetal development were observed at the maximum recommended dose of 1000 mg/kg bw day administered to female Spraque-Dawley rats between day 5 and day 19 of gestation. No maternal toxicity was observed at this dose level as well.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Oral guideline conform developmental toxicity study in rats according to recent guidelines and under GLP. No effects were observed at the recommended upper limit dose of 1000 mg/kg bw/day.
Additional information
Based on the absence of developmental effects in a pre-natal study for developmental toxicity in Spraque Dawley rats receiving the test substance up to the maximum recommended dose level of 1000 mg/kg bw/day by oral gavage the substance is not considered to have any effects on the developing embryo or fetus and it is consequently not classified for developmental toxicity.
Justification for classification or non-classification
Based on the available data that did not show any effect of the test substance on male and female sex organs in a 28 -day oral gavage study in rats up to a dose level of 1000 mg/kg bw/day and the absence of effects on developmental toxicity in a prenatal developmental toxicity study in rats up to dose levels of 1000 mg/kg bw/day a classification for reproductive endpoints is not warranted.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.