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EC number: 411-850-0 | CAS number: 119018-29-0 GLIMEPIRID-SULFONAMID; GLIMEPIRIDE SULFONAMIDE
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 407
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat / Wistar Hoe: WISKF (SPF 71)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- Method of administration:
Suspension - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 40 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 40 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
No lethality.
Increased salivation, irregular respiration and crunched
posture as well as swelled up abdomen in females in the high
dose group occurred. In some animals of the intermediate
group also an increased salivation was observed.
In some males of the high dose group a slight decrease of
the body weight was detected. In the females the food
consumption was slightly increased in the high dose group,
also the water consumption was increased of males and
females as well as of some males in the intermediate group.
Laboratory findings:
The haematologic examinations did not show any changes.
Clinical-chemical a slight increase of the GGT-activity in
the females and in one male of the high dose animals was
observed.
In the urine an increased number of precipitations was seen
in animals of the high and intermediate dose group. In the
females of the high dose group additionally an increase of
the volume and in all animals a turbidity was observed.
Effects in organs:
The organ weights of liver, kidneys and adrenals were
increased in the animals of the high dose group. In the
males of the intermediate dose group a slight increase of
the relative kidney weights and in females a slight increase
of the relative liver weights was detected.
Histopathologic liver necrosis was detected in three females
of the high dose group.
In two animals of the intermediate dose and in four animals
of the high dose group changes induced by foreign bodies
were observed in the bladder.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 40 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
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