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EC number: 208-517-5 | CAS number: 531-75-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Aesculin
- EC Number:
- 208-517-5
- EC Name:
- Aesculin
- Cas Number:
- 531-75-9
- Molecular formula:
- C15H16O9
- IUPAC Name:
- aesculin
- Test material form:
- solid: particulate/powder
- Details on test material:
- batch no. 182-72-2
Constituent 1
- Specific details on test material used for the study:
- Preparation of the Test Item In order to get the test item in a solution or suspension, which is applicable to the animals, corn oil (Sigma-Aldrich, lot no. MKCD1021, expiry date: 30 June 2018) was evaluated as vehicle and was considered to be adequate. This vehicle was chosen due to its non-toxic characteristics. The test item was weighed out into a tared plastic vial on a precision balance. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before each dose administration. For all animals of the first step, 1.007 g of the test item was suspended with the vehicle to gain a final volume of 5 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight. For all animals of the second step, 2.007 g of the test item was suspended with the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight. The dose formulations were made shortly before each dosing occasion.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species/strain: Healthy rats, e.g. WISTAR rats Crl: WI(Han) (full barrier)
Source: E.g. Charles River, 97633 Sulzfeld, Germany
Sex: Female (non-pregnant, nulliparous)
Age at the beginning
of the study: 8 – 12 weeks old
Body weight on the day
of administration: Interval within ± 20% of the mean weight of any previously dosed animals, if technically possible.
Number of animals: 3 per step. Normally 2 - 4 steps will be necessary.
Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test item will be administered at a single dose by gavage using a feeding tube.
Volume of administration: The test item will be administered according to body weight at a volume of 5 to 20 mL/kg body weight, depending on the solubility of the test item. For liquids the test item may be administered according to the chosen starting dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 per step
- Details on study design:
- All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
At the end of the observation period the surviving animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of 250-400 mg/kg bw. All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation. - Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat. (dissolved fraction)
- Remarks on result:
- other: preliminary result
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item Aesculin to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but not with mortality. The median lethal dose of Aesculin after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 5000 mg/ kg bw
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