Registration Dossier

Diss Factsheets

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:
2013
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

Constituent 1
Chemical structure
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
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