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Description of key information

Acute toxicity: via oral route

The LD50 of CR SB07 was greater than 2000 mg/kg B.W. (OECD TG423).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 25, 2016 to November 23, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system 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
Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg B.W.
No. of animals per sex per dose:
Three
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

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

2.2

210.8

261.1

+50.3

02F

2.2

213.6

260.5

+46.9

03F

2.2

215.3

253.5

+38.2

Group 2

04F

2.2

217.8

261.9

+44.1

05F

2.2

217.9

252.1

+34.2

06F

2.2

219.7

269.6

+49.9

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

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
According to OECD 423 test method, the LD50 of CR SB07 was greater than 2000 mg/kg B.W.. Therefore, CR SB07 was Category 5 based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab for M62-151100050001EN 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 SB07 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 SB07 was greater than 2,000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute toxicity: via oral route

A total of 6 female Sprague-Dawley rats were orally dosed with CR SB07 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 SB07 was greater than 2,000 mg/kg.

 

Justification for classification or non-classification