Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
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.
Details on test animals 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
Route of administration:
oral: gavage
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.
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:
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat. (dissolved fraction)
Remarks on result:
other: preliminary result
Interpretation of results:
GHS criteria not met
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
Endpoint conclusion
Dose descriptor:
5 000 mg/kg bw
Quality of whole database:
LD50 >2000 mg/kg bw, LD50 cut-off (rat): 5000 mg/kg
OECD guideline study

Additional information

Justification for classification or non-classification