Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 2-1-1
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- (2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride
- Cas Number:
- 2171323-89-8
- Molecular formula:
- C18H20CIF2NO2
- IUPAC Name:
- (2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride
Constituent 1
- Specific details on test material used for the study:
- Substance name: X12485647
Lot #: SS17000602-2 (TSN402954)
Purity: 98%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Reverse osmosis
- Doses:
- 2000 and 300 mg/kg
- No. of animals per sex per dose:
- 03 females at 2000 mg/kg and 6 females at 300 mg/kg
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two mortalities were observed in rats treated with 2000 mg/kg body weight and
one morality was observed in rats treated with 300 mg/kg body weight. - Clinical signs:
- other: Tremors were observed in rats treated at 2000 mg/kg body weight while no clinical sign was observed in rats treated at 300 mg/kg body weight.
- Gross pathology:
- No external gross abnormality. Internal examination of the found-dead rats revealed lungs: reddish discolouration (one rat) and stomach: multiple white foci (two rats) whereas the other terminally sacrificed rats did not reveal any abnormality.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Oral LD50 cut-off value (Female Rat): 1000 mg/Kg body weight
- Executive summary:
The acute oral toxicity of the test substance was investigated using the acute toxic class method. Female Wistar rats (RccHan:WIST), (approximately 10-12 weeks old and weighing 173.2-201.7 g at dosing) were given a single oral dose of the test substance following an overnight fasting using reverse osmosis water (RO water) as a vehicle and at a constant dose volume (10 mL/kg).
Initially, three female rats (set I) were administered 2000 mg/kg body weight. As two mortalities were observed at this dose level, another set of three female rats (set II) were administered with a lower dose of 300 mg/kg body weight. As no mortality was observed at this dose level, another set of three female rats (set III) were administered at an interval of a minimum 48 h with the same dose of 300 mg/kg body weight. As one mortality was observed at this dose level, testing was concluded.
Surviving rats were then observed for 14 days (mortality, clinical signs, and body weights were recorded) after which they were sacrificed and subjected to a gross necropsy examination.
Tremors were observed in rats treated at 2000 mg/kg body weight while no clinical signs were observed in rats treated at 300 mg/kg body weight.
All surviving rats gained weight during the study. Changes in the body weight were considered within the expected range for this strain and age of rats and not influenced by the treatment.
No external gross abnormality was observed at necropsy. Internal examination of the found-dead rats revealed lungs: reddish discolouration (one rat) and stomach: multiple white foci (two rats) whereas the other terminally sacrificed rats did not reveal any abnormality.
In conclusion, based on the study results, the acute oral median lethal dose (LD50 cut-off value) of the test substance in female Wistar rats was found to be 1000 mg/kg body weight.
Based on results of this study, the GHS classification of the test substance for acute oral toxicity is as follows: Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2019): Category 4
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