Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From to July 25, 2016 November 23, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
- Source: BioLASCO Taiwan Co., Ltd (Taipei, Taiwan)
- Age at study initiation: about 8 week old
- Housing: two animals per cage
- Water: ad libitum
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Photoperiod (hrs dark / hrs light): 12-hrs dark / 12-hrs light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
three

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Table 1. Body weight of the rats in the study period

Animal I.D.

Dosing volume

(mL)

Body weight (g)

Weight changes

(g)

Day 1

Day 14

Group 1

01F

2.3

228.4

265.5

+37.1

02F

2.3

227.7

267.2

+39.5

03F

2.3

227.0

268.6

+41.6

Group 2

04F

2.3

225.8

264.8

+39.0

05F

2.3

220.7

256.1

+35.4

06F

2.3

221.0

255.6

+34.6

Table 2. Clinical observation of the rats

Animal I.D.

Clinical sign observation

30

mins

4

hrs

D2

D3

D4

D5

D6

D7

D8

D9

D10

D11

D12

D13

D14

Group 1

01F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

02F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

03F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

Group2

04F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

05F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

06F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N: Normal.

D2-D14: Day 2-Day 14.

 

Table 3. Results of gross necropsy examination

Animal I.D.

Dose

Gross lesion

Group 1

01F

2,000 mg/kg B.W.

No significant lesion founded

02F

No significant lesion founded

03F

No significant lesion founded

Group 2

04F

2,000 mg/kg B.W.

No significant lesion founded

05F

No significant lesion founded

06F

No significant lesion founded

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
According to OECD 423 test method, the LD50 of CR SB87 was greater than 2000 mg/kg B.W.. Therefore, CR SB87 was Category 5 based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab for M62-151100114001EN which is based on the SOP (SOPP-341) for the OECD 423 and OECD 423 (OECD, 2001). A total of 6 female Sprague-Dawley rats were orally dosed with CR SB87 in three animals each group, at 2000 mg/kg b.w. for both Group 1 and Group 2 in limit test. All animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. In absence of mortality or other significant clinical signs of toxicity, LD50 of CR SB87 was greater than 2,000 mg/kg.