Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-11-28~2014-12-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report):Everdirect SH05(DR224)
- Substance type:Powder
- Composition of test material, percentage of components:68.89%
- Lot/batch No.:4501
- Expiration date of the lot/batch:2016-10-31
- Storage condition of test material:Refrigeration (5 ± 3℃)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5 g/kg b.w.
No. of animals per sex per dose:
Five male and five female
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Table 1 : Body weight of the rats

Animal I.D.

Dosing volume (mL)

Body weight (g)

Weight changes (g)

Day 1

Day 7

Day 14

Male

 

01

8.5

211.1

288.7

352.6

+141.5

02

8.6

214.4

285.1

330.3

+115.9

03

8.3

207.0

279.1

323.5

+116.5

04

8.8

219.2

307.2

371.4

+152.2

05

8.0

198.2

270.3

320.3

+122.1

Female

 

06

6.4

159.1

184.2

200.3

+41.2

07

6.8

167.9

204.8

235.3

+67.4

08

6.7

165.8

206.6

224.5

+58.7

09

6.3

157.5

183.7

197.5

+40.0

10

6.2

154.3

180.6

200.8

+46.5

Table 2 : Clinical observation of the rats

Animal I.D.

Clinical sign observation

30 mins

4 hours

D2

D3

D4

D5

D6

D7

D8

D9

D10

D11

D12

D13

D14

Male

 

01

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

02

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

03

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

04

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

05

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

Female

 

06

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

07

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

08

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

09

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

10

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

Table 3 : Results of gross necropsy examination

Animal I.D.

Dose

Gross lesion

Male

 

01

5 g/kg b.w.

No significant lesion founded

02

No significant lesion founded

03

No significant lesion founded

04

No significant lesion founded

05

No significant lesion founded

Female

 

06

5 g/kg b.w.

No significant lesion founded

07

No significant lesion founded

08

No significant lesion founded

09

No significant lesion founded

10

No significant lesion founded

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test dose of this study was 5 g/kg b.w.. Result showed that all treated rats survived till the end of the study and there was no significant gross lesions founded during the gross necropsy examination.
Executive summary:

According to OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure), the median lethal dose (LD50) of test article was greater than 5 g/kg b.w..