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Administrative data

Description of key information

Acute toxicity: via oral route

The LD50 of Everzol Blue ED-G(Everzol SB26) was greater than 5000 mg/kg B.W. (EPA OPPTS 870.1100 and OECD TG401).

 

Acute toxicity: via dermal route

The LD50 of Everzol SB26 was greater than 2000 mg/kg B.W. (OECD TG402).

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:
Single dose
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: BioLASCO Taiwan Co., Ltd.
- Age at study initiation: about 5 week old
- Fasting period before study: overnight
- Housing: in polycarbonate cage
- Water: ad libitum
- Temperature (°C): 20-25 °C
- Humidity (%): 40-70 %
- Photoperiod: 12-hrs dark / 12-hrs light cycle
Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
For male: five
For female: five
Control animals:
yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
No adverse effects
Body weight:
No significant differences

Table 1. Symptoms and time course of death of rats administered by gavage with Everzol Blue ED-G

Sex

Dose

(mg/kg)

Treated

No.

Symptom

No. Observed

Total No. of death

Hour

Day

1

2

4

1

2

3

4

5

6

7

14

Male

0

5

Normal

5

5

5

5

5

5

5

5

5

5

5

 

Death

0

0

0

0

0

0

0

0

0

0

0

0

5,000

5

Normal

5

5

5

5

5

5

5

5

5

5

5

 

Death

0

0

0

0

0

0

0

0

0

0

0

0

Female

0

5

Normal

5

5

5

5

5

5

5

5

5

5

5

 

Death

0

0

0

0

0

0

0

0

0

0

0

0

5,000

5

Normal

5

5

5

5

5

5

5

5

5

5

5

 

Death

0

0

0

0

0

0

0

0

0

0

0

0

Table 2. Mortality rate of rats administered by gavage with Everzol Blue ED-G

Dose

(mg/kg body weight)

Dead No./Treated No.

Mortality1)

(%)

Male

 Female

Total No.

Control

0/5

0/5

0/10

0

5,000

0/5

0/5

0/10

0

1) Mortality (%) = Dead No.÷Treated No. × 100%

Table 3. The body weight changes of rats administered by gavage with Everzol Blue ED-G on days 0, 7 and 14

Sex

Dose

(mg/kg body weight)

Body weight (g)1)

Day 0

Day 7

Day 14

Male

Control

181.5 ± 4.7

205.2 ± 11.5

229.9 ± 20.8

5,000

180.6 ± 4.2

219.1 ± 19.2

240.9 ± 31.3

Female

Control

159.3 ± 5.2

174.3 ± 4.5

198.4 ± 6.0

5,000

159.2 ± 3.2

187.3 ± 11.8

203.1 ± 18.5

1) Mean ± S.D., n=5. Means in each column followed by asterisk (*) indicate significant difference at ρ<0.05 level by Student’st-test.

 

Table 4. The body weight gains of rats administered by gavage with Everzol Blue ED-G on days 7 and 14

Sex

Dose

(mg/kg body weight)

Body weight gain (g)1)

Day 72)

Day 143)

Male

Control

23.6 ± 9.6

48.4 ± 18.7

5,000

38.5 ± 15.7

60.3 ± 28.2

Female

Control

15.1 ± 3.6

39.1 ± 7.0

5,000

28.1 ± 12.6

43.9 ± 20.0

1) Mean ± S.D., n=5. Means in each column followed by asterisk (*) indicate significant difference at ρ<0.05 level by Student’st-test.

2) Body weight (BW) gain on the 7thday = (7th-0th) BW (g).

3) Body weight (BW) gain on the 14thday = (14th-0th) BW (g).

Interpretation of results:
GHS criteria not met
Conclusions:
According to EPA OPPTS 870.1100 and OECD 401 test method, the LD50 of Everzol Blue ED-G was greater than 5000 mg/kg B.W.. Therefore, Everzol Blue ED-G is not classified according to CLP regulation.
Executive summary:

This test using the procedures outlined in the TACTRI for 0136Y07AORe which is based on the USEPA OPPTS 870.1100(US EPA 712-C-98-190) and OECD 401 (OECD, 2002). Wistar rats were administered by gavage with Everzol Blue ED-G at a fixed dose of 5,000 mg/kg body weight. At the end of experiment, all animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. The acute oral LD50 of Everzol Blue ED-G was greater than 5,000 mg/kg body weight in rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 22, 2016 to December 08, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: BioLASCO Taiwan Co. Ltd.
- Age at study initiation: about 7 weeks old
- Housing: Male and female rats were fed, respectively. Two rats per cage in an autoclaved polyethylene cage.
- Acclimation period: 7 Days
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12 hrs dark / 12 hrs light
Type of coverage:
occlusive
Duration of exposure:
24 hours
Doses:
2000 mg/kg B.W.
No. of animals per sex per dose:
Six of male and six female
Control animals:
yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level

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

Group

Animal I.D.

Dosing volume (mL)

Body weight (g)

Weight chenges(g)

Day 1

Day 14

Control

01M

0.5

246.6

345.4

+98.8

02M

0.5

240.2

349.6

+109.4

03M

0.5

266.4

355.2

+88.8

04M

0.5

256.3

352.8

+96.5

05M

0.6

283.5

385.8

+102.3

06M

0.5

271.6

370.0

+98.4

Test

07M

0.5

267.7

359.7

+92.0

08M

0.5

262.7

365.6

+102.9

09M

0.5

249.4

356.9

+107.5

10M

0.5

271.4

352.5

+81.1

11M

0.5

264.1

361.1

+97.0

12M

0.6

275.0

383.0

+108.0

Control

13F

0.4

204.6

260.2

+55.6

14F

0.4

219.4

258.0

+38.6

15F

0.4

220.5

275.2

+54.7

16F

0.4

218.0

275.9

+57.9

17F

0.5

230.2

270.9

+40.7

18F

0.4

219.5

270.5

+51.0

Test

19F

0.4

206.0

254.0

+48.0

20F

0.4

211.4

248.1

+36.7

21F

0.5

225.1

287.3

+62.2

22F

0.4

223.3

271.5

+48.2

23F

0.4

224.7

282.6

+57.9

24F

0.5

239.5

299.7

+60.2

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

01M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

02M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

03M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

04M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

05M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

06M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

07M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

08M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

09M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

10M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

11M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

12M

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

13F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

14F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

15F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

16F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

17F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

18F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

19F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

20F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

21F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

22F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

23F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

24F

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

DX: Day X in the study period

N: Normal

Table 3. Results of gross necropsy examination

Animal I.D.

Dose

Gross lesion

01M

No significant lesion founded

02M

No significant lesion founded

03M

No significant lesion founded

04M

No significant lesion founded

05M

No significant lesion founded

06M

No significant lesion founded

07M

2000 mg/kg B.W.

No significant lesion founded

08M

No significant lesion founded

09M

No significant lesion founded

10M

No significant lesion founded

11M

No significant lesion founded

12M

No significant lesion founded

13F

No significant lesion founded

14F

No significant lesion founded

15F

No significant lesion founded

16F

No significant lesion founded

17F

No significant lesion founded

18F

No significant lesion founded

19F

2000 mg/kg B.W.

No significant lesion founded

20F

No significant lesion founded

21F

No significant lesion founded

22F

No significant lesion founded

23F

No significant lesion founded

24F

No significant lesion founded

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 402 test method, the LD50 of Everzol SB26 was greater than 2000 mg/kg B.W.. Therefore, Everzol SB26 was Category 5 based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab for M62-151100129001EN which is based on the SOP (SOPP-342) for the OECD 402and OECD 402 (OECD, 1987). Six male and six femaleSprague-Dawley rats for each group were used in limit test. For Test group, 12Sprague-Dawley ratsweredermally dosed with 2000 mg/kg B.W. of Everzol SB26. 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 ofEverzol SB26was greater than 2,000 mg/kg B.W..

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

Additional information

Acute toxicity: via oral route

Wistar rats were administered by gavage with Everzol Blue ED-G(Everzol SB26) at a fixed dose of 5,000 mg/kg body weight. At the end of experiment, all animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. The acute oral LD50 of Everzol Blue ED-G (Everzol SB26) was greater than 5,000 mg/kg body weight in rats.

 

Acute toxicity: via dermal route

Six male and six femaleSprague-Dawley rats for each group were used in limit test. For Test group, 12 Sprague-Dawley rats were dermally dosed with 2000 mg/kg B.W. of Everzol SB26. 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 Everzol SB26was greater than 2,000 mg/kg B.W..

Justification for classification or non-classification