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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

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
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
solid: particulate/powder
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

Details on test animals or test system and environmental conditions:
- 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.

- 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.
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:
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
Dose descriptor:
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
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.