Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July - September 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Details on test material:
clear, colourless liquid
Production date: 14. Jan. 2018
Expiry date: 14. Jan. 2021
Storage: room temperature (20 ± 5 °C)
Batch no.: 701146_43343114

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Velaz, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 178 - 194 g
- Fasting period before study: yes
- Housing: housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning
- Diet: laboratory food ssniff (Spezialdiäten GmbH, Germany), offered at recommended doses each day approximately at the same time
- Water (ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.0 - 23.4
- Humidity (%): 54.7 ± 2.3
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.8 mL/kg
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2, 4 h after administration + daily for the next 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
Body weight:
The body weight of animals increased during the study.
Gross pathology:
no findings

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 of the test item is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
The test item is classified in GHS Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.
Executive summary:

The test item was administered to 6 female Wistar rats at a limit dose of 2000 mg/kg. All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.The limit dose did not cause death or evident signs of toxicity. During the follow up period, no other signs of intoxication, change of health, nor any other adverse reactions were displayed.The body weight of animals increased during the study.The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.