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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Start : 27 January 1998 End : 12 February 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study performed according OECD and or EC guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: TS-2863
Description: White solid
Batch: 85-36
Purity: 99.8%
Test substance storage: at room temperature in the dark
Stability under storage conditions: stable
Expiry date: 18 December 1998

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Species Rat, Wistar strain Crl:(WI) BR (outbred, SPF-Quality).
Recognised by international guidelines as the recommended
test system (e.g. OECD, EC).
Source: Charles River, Sulzfeld, Germany.
Number of animals 6 Animals. Each dose group consisted of 3 animals of one
sex (females were nulliparous and non-pregnant).
Age and body weight Young adult animals (approx. 8 weeks old) were selected.
Body weight variation did not exceed +1- 20% of the sex
mean.
Identification: Earmark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
The vehicle was selected based on a pretest performed at NOTOX.
The formulations (wlw) were prepared immediately prior to
dosing. Adjustment was made for specific gravity of
vehicle. Homogeneity was accomplished to a visually
acceptable level.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Mortality/Viability Twice daily.
Body weights Days 1 (pre-administration), 8 and 15.
Clinical signs At periodic intervals on the day of dosing (day 1) and
once daily thereafter, until day 15.
Necropsy At the end of the observation period, all animals were
sacrificed by asphyxiation using an oxygen/carbon dioxide
procedure and subjected to necropsy. Descriptions of all
internal macroscopic abnormalities were recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
Lethargy, hunched posture and uncoordinated movements were noted among the
animals on day 1 only.
Body weight:
The body weight gain shown by the animals over the study period was considered
to be similar to that expected of normal untreated animals of the same age and
strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the
animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of TS-2863 in Wistar rats was established as exceeding 2000
mglkg body weight.
Based on these results and according to the EC criteria for classification and
labelling requirements for dangerous substances and preparations (Guidelines in
Commission Directive 931211EEC), TS-2863 does not have to be classified and has
no obligatory labelling requirement for oral toxicity.