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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25.03. 2019 – 11.04. 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: SPF breeding, VELAZ s.r.o., Lysolajské údolí 15/53, 165 00 Prague 6, Czech Republic, RČH CZ 11760500
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 185-195 g
- Fasting period before study: 20 h
- Housing: individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 22 ± 3 C, permanently monitored
- Humidity (%): relative humidity 30 – 70 %, permanently monitored
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
VEHICLE
- The single volume of administered suspension was 1 mL/100 g of animal body weight.
- Justification for choice of vehicle: The test item does not make a homogenous suspension with water, olive oil.
- Lot/batch no. (if required): 21031PO316
- Purity: 99.0%

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was 2000 mg/kg of body weight, according the test guideline, because there is information, that test item is not toxic from sponsor (Confidential Test Substance Data Sheet).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females per group, 2 groups
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: before application, 8th day and before euthanasia of animals
- Necropsy of survivors performed: yes
- Mortality: daily
- Clinical examination: daily (changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system)
- Pathological examination:15th day (nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity)
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No clinical signs of intoxication were observed in all 6 females at the dose 2000 mg/kg (group No. 1 and No. 2) during the clinical observation after the application
Body weight:
Weight increments in group No. 1 and group No. 2 were adequate to species, sex and age of animals in experiment.
Gross pathology:
No pathological macroscopic changes
Interpretation of results:
GHS criteria not met
Conclusions:
The test item toxicity was evaluated on the basis of mortality, clinical signs of intoxication, body weight increments during the observation period and necropsy findings at the end of study.
The test item administered at the dose of 2000 mg/kg of body weight caused no death of any animal. No serious clinical signs of intoxication were detected at this dose during the whole study. Weight increments were adequate to species, sex and age of animals in experiment. No pathological macroscopic changes were diagnosed during the pathological examination.
According to the study results, the LD50 value of the test item, Propatyl nitrate, for female rats is higher than 2000 mg/kg of body weight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification