Registration Dossier
Registration Dossier
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EC number: 844-009-5 | CAS number: 167173-85-5
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:
- 2 013
- Report date:
- 2013
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:
- (3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
- Cas Number:
- 167173-85-5
- Molecular formula:
- C26H30N2O9
- IUPAC Name:
- (3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
Constituent 1
- Specific details on test material used for the study:
- Substance ID: X642188
Batch #: SYN-FS08353-048 (TSN303567)
Purity: 99%
Test animals
- Species:
- rat
- Strain:
- other: RccHan:WIST
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% Carboxymethyl Cellulose
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Three females/set
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No treatment-related clinical signs were observed in any treated rats
- Gross pathology:
- No gross lesions were present in the rats at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50 (Female Rat): >2000 mg/Kg body weight
- Executive summary:
In an acute oral toxicity study, two sets (set I and II) of fasted Wistar rats (3 females/set) were given a single oral dose of the test substance in 0.5% carboxymethyl cellulose in a stepwise manner at a dose of 2000 mg/kg body weight and observed for 14 days.
There were no mortality and no treatment-related clinical signs observed.
There were no treatment-related changes in body weight or necropsy findings.
The acute oral median lethal dose (LD50 cut off value) of the test substance in Wistar rats was found to be greater than 2000 mg/kg body weight.
Based on the results of this study, an indication of the classification for the test substance is as follows: Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2011): Unclassified
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