Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No standard stated in the study report, however report is robust.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Not specified
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Referenced as TVCI within the report.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals: Sprague-Dawley male and female rats obtained from Charles River Breeding Laboratories.
Weight Range: At initiation, 127 – 260 grams.
Diet: Animals were fasted twenty-four hours prior to dosing. Immediately following dosing, the animals were given food; (Wayne Lab-Blox) and water, ad libitum.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
vegetable oil
Details on oral exposure:
A constant volume of 25 or 30 ml/kg was maintained using vegetable oil as a diluent.
Doses:
10 gm/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Mortality and Toxic Effects:
Following dosing, all animals were observed immediately and hourly for eight hours each day for 14 days.

Terminal Studies:
On day 14, post-administration, all animals were killed and a gross necropsy performed.
Statistics:
None specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured.
Clinical signs:
No changes noted.
Body weight:
No changes noted.
Gross pathology:
No visible compound-related lesions found.
Other findings:
None specified

Any other information on results incl. tables

 

Animal No.

Sex

Weight (grams)

ml Admin.

Observed Mortality

Total Deaths

Day

Initial

Final

1

2

3

4

5

6

7

8

9

10

11

12

13

14

1

M

259

354

7.80

 

 

 

 

 

 

 

 

 

 

 

 

 

 

0/10

2

M

245

319

7.40

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

M

248

319

7.40

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4

M

260

357

7.80

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5

M

235

346

7.00

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6

F

153

213

4.60

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7

F

150

211

4.50

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8

F

142

200

4.30

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9

F

144

190

4.30

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10

F

150

203

4.50

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Observation: No visible change

Necropsy Findings: No visible lesions

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 >10 gm/kg
Executive summary:

A single administration was given to five male and five female Sprague-Dawley rats at a dose of 10 gm/kg. No mortality was seen in the rats.

LD50 >10 g/kg