Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to EU/OECD-guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium 4-(methoxycarbonyl)-5-oxo-2,5-dihydrofuran-3-olate
EC Number:
627-063-2
Cas Number:
1134960-41-0
Molecular formula:
C6H5O5Na
IUPAC Name:
sodium 4-(methoxycarbonyl)-5-oxo-2,5-dihydrofuran-3-olate

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 animals, 3 animals/group
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The test substance did not cause mortality at a dose level of 2000 mg/kg bw.
Clinical signs:
Treatment with the test substance did not cause any clinical signs during the 14 days observation period.
Body weight:
Body weight and body weight gain of test substance treated animals showed no indication of a treatment-related effect.
Gross pathology:
No macroscopic observations were seen in animals dosed at 2000 mg/kg bw and terminated on Day 14.

Any other information on results incl. tables

Mortality

BYI 02960-BCS-CL71543 (Na-CMTS) did not cause mortality at a dose level of 2000 mg/kg bw.

Clinical observations

Treatment with BYI 02960-BCS-CL71543 (Na-CMTS) did not cause any clinical signs during the 14 days observation period.

Body weight and body weight gain

Body weight and body weight gain of BYI 02960-BCS-CL71543 (Na-CMTS) treated animals showed no indication of a treatment-related effect.

Macroscopic Findings

No macroscopic observations were seen in animals dosed at 2000 mg/kg bw and terminated on Day 14.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
The test substance is non-toxic after acute oral administration at dose level of 2000 mg/kg bw.
The study result triggers the following classification/labelling:
- EU Directive 1999/45/EC (as amended): none
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 4) 2011: unclassified