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EC number: 946-101-1 | 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
In the absence of significant adverse effects, a NOAEL of 1000 mg/kg bw/day has been considered further for hazard assessment.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - 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:
- Guideline compliant study
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 study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study was conducted to determine the oral repeated dose toxicity of the test substance according to OECD Guideline 422, EU Method B.7, EPA OPPTS 870.3650 and EPA OPPTS 870.3050, in compliance with GLP. Male and female Wistar Han rats were exposed (by gavage) to the test substance at dose levels of 100, 300 and 1000 mg/kg bw/day from 14 days before mating (Day 1) until Day 31 for males or until Day 4 of lactation for females. A control group of 10 male and 10 female rats was given 5 mL/kg bw/day of the vehicle (corn oil) over the same periods. All animals were observed at least twice daily for morbidity and mortality. Clinical signs were recorded daily during the study. To detect any clinical signs or reactions to treatment, the animals were observed before and at least once after dosing. A full clinical examination was performed on each weighing day. A particular attention was paid to hypersalivation. Body weight was measured once per week in males and once per week during pre-mating and mating periods, on Days 0, 6, 9, 12, 15, 18 and 20 of gestation and on days 1 and 4 of lactation in females. Food consumption was evaluated one per week during the pre-mating period in males and weekly during the pre-mating period, on days 0 to 6, 6 to 9, 9 to 12, 12 to 15, 15 to 18, 18 to 20 of gestation and on days 1 to 4 of lactation in females. Functional tests were performed on males (on the last day of treatment (i.e. Day 31)) and females (females with live pups at the time of test (i.e. lactation day 4)). The tests performed included auditory reflex, pupillary reflex, righting reflex, fore- and hind-limb grip strength and locomotor activity in an open field test. Blood sampling were taken at the end of the pre mating period (i.e. Day 14) from the retro-orbital sinus for heamatology, coagulation and serum clinical chemistry analysis. Adult animals were killed by carbon dioxide inhalation followed by exsanguination then necropsied according to the following schedule: after completion of the mating period for males and on Day 4 of lactation for females. All animals were submitted to a macroscopic examination. For half of the animals/group, selected organs were weighed, and organ/tissue samples were fixed and preserved at necropsy. A limited list of organ/tissue samples were fixed and preserved at necropsy for the remaining animals. Selected organs/tissues, from half of the group 1 (0 mg/kg bw/day) and 4 (1000 mg/kg bw/day) animals killed at the end of the treatment period were examined histopathologically. Oral administration of the test substance at tested doses, were associated with a non-adverse minor decrease in mean body weight gain for males and females during lactation at 300 and 1000 mg/kg bw/day, a slight reduction of food consumption for all treated females (from Day 9 and Day 15 of pre-mating) and from Day 1 to Day 4 of lactation at 1000 mg/kg bw/day and a dose-related decrease in bile acids in test substance-treated males at all dose levels and females at 300 and 1000 mg/kg bw/day. For details on effects on reproduction refer to the discussion under section 5.9.3 of the CSR. Under the study conditions, the NOAEL for parental systemic toxicity of the test substance was determined to be 1000 mg/kg bw/day (highest dose tested) (Mounier, 2017).
Justification for classification or non-classification
Based on the results of the combined repeated dose with reproductive and development screening study, the test substance does not meet the criteria for classification for this endpoint according to CLP (Regulation 1272/2008/EC) criteria.
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