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EC number: 214-060-2 | CAS number: 1076-38-6
- 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
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- 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:
- Experimental start: March 5, 2021; experimental completion: April 2, 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-hydroxycoumarin
- EC Number:
- 214-060-2
- EC Name:
- 4-hydroxycoumarin
- Cas Number:
- 1076-38-6
- Molecular formula:
- C9H6O3
- IUPAC Name:
- 4-hydroxycoumarin
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Identification: 4-Hydroxycoumarin
CAS Number: 1076-38-6
Batch: HCN20002
Purity: 100.3%
Molecular Weight: 162.14
Physical state/Appearance: off white powder
Expiry Date: 26 September 2022
Storage Conditions: 15-25°C protected from light
Test animals
- Species:
- rat
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: commonly used laboratory strain will be obtained from an accredited supplier.
- Age at study initiation: 8-12 weeks
- Fasting : yes
- Housing: Cages conforming to the 'Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes’ (Home Office, London, 2014).
- Diet (e.g. ad libitum): The animals will have access ad libitum to 5LF2 EU Rodent Diet, except for a period of fasting from the evening of the day prior to dosing (Day-1) until approximately 3 hours after dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 40 to 70%.
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
- Air: A minimum of 15 air changes/hour.
Administration / exposure
- Route of administration:
- oral: gavage
- Details on oral exposure:
- The test article will be dispersed in a physiologically compatible vehicle, with preference given to purified water, 1% w/v aqueous methyl cellulose or corn oil.
- Doses:
- The first dose level is selected from four possible doses (5, 50, 300 or 2000 mg/kg) using available information from the Sponsor or from literature. If no information is available then a starting dose of 300 mg/kg will be selected.
- No. of animals per sex per dose:
- Dose-range finding study: 1
Definitive study: 5 - Control animals:
- no
- Details on study design:
- Groups of animals of a single sex are dosed in a stepwise procedure using fixed doses of the test article at 5, 50, 300 or 2000 mg/kg. The initial dose level, selected on the basis of results of a sighting study, is the dose expected to cause some signs
of toxicity without causing severe toxic effects or mortality. The selected dose levels will be recorded by the Study Director on a dispensary request form. Further groups of animals may be dosed at higher or lower fixed doses, depending
on the presence or absence of clinical signs or mortality (following the flow diagram presented in Section 9). This procedure continues until the dose causing evident toxicity or no more than one death is identified, or when no effects are seen at the
highest dose or when deaths occur at the lowest dose. Evident toxicity, as described in the Test Guideline, is a general term which describes clear signs of toxicity following administration of test article which are of
a severity such that administration at the next highest fixed dose level can be expected to cause either severe pain and enduring signs of severe distress, a moribund state or probable mortality in most animals.
Results and discussion
- Preliminary study:
- None of the animals died at the highest dose of 2000 mg/kg dose level.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the results from the Acute Exposure Oral Toxicity in rats, the, definitive acute oral LD 50 for femaless for the test item was determined to be > 2000 mg/kg. Based on the LD50 and the criteria of the CLP Regulation, the test item is not classified for acute oral toxicity.
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