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Administrative data

Description of key information

Acute toxicity: via oral route

The LD50 of Everlan Brown EFR Dye Powder was greater than 5000 mg/kg (EPA).

 

Acute toxicity: via dermal route

The LD50 of Everlan SL65 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:
March 21, 1995 - May 21, 1995.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: USA EPA test
Qualifier:
equivalent or similar to guideline
Guideline:
other: Principles and Method of Toxicology
Version / remarks:
1994 / Hayes, A.W.
GLP compliance:
no
Test type:
standard acute method
Specific details on test material used for the study:
- Name of test material: Everlan Brown EFR Dye Powder

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: Laboratory Animal Center, National Taiwan University.
- Age at study initiation: about 5 week old
- Housing: in cage
- Diet: ad libitum
- Water: ad libitum
- Temperature (°C): 25 ± 1 °C
- Humidity (%): 50-70 %
- Photoperiod: 12-hrs dark / 12-hrs light cycle
Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
yes
Details on study design:
Intoxicant symptoms, symptom occurrence, and death are recorded 1/2, 1, 2, and 4 hours after dosing. From the second day to 14th day, all rats are inspected once daily.
Treated rats are necropsied and all gross pathological changes were recorded.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Table 1. Acute oral toxicity of Everlan Brown EFR Dye Powder in rats

Dose

(mg/kg)

Mortality for 14 days

Male

Female

Total

Control

5000

0/5

0/5

0/5

0/5

0/10

0/10

Table 2. The time course of death caused by the oral administration of Everlan Brown EFR Dye Powder

Sex

Days after administration

0

1

2

3

4

5

6

7

14

Male

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Table 3. Body weight change of rats gavaged with Everlan Brown EFR Dye Powder

Sex

Dose mg/kg

Days after administration

0

7

14

Male

Control

5000

209.0±10.1

204.4±11.2*

232.4±12.8

224.6±11.5*

261.0±12.9

253.0±13.7*

Female

Control

5000

208.4±11.6

201.8±11.5*

230.0±10.7

222.8±11.3*

262.2±12.4

250.6±11.4*

* Significant difference between control and treated group

Table 4. Percentages of body weight change of rats gavaged with Everlan Brown EFR Dye Powder by F-test

Sex

Dose mg/kg

Days after administration

7

14

Male

Control

5000

11.2±1.3

9.9±0.8

24.9±1.1

23.8±2.4

Female

Control

5000

10.4±2.0

10.4±1.4

25.4±2.7

24.2±1.7

Interpretation of results:
GHS criteria not met
Conclusions:
According to recommend USA EPA test and good laboratory practice (GLP) guidelines, the LD50 of Everlan Brown EFR Dye Powder was greater than 5000 mg/kg. Therefore, Everlan Brown EFR Dye Powder was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the TACTRI for TXD45ao which is based on the USA EPA test and "Principles and Method of Toxicology (1994)".Wistar rats were administered by gavage with Everlan Brown EFR Dye Powder at a fixed dose of 5,000 mg/kg. 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 Everlan Brown EFR Dye Powder was greater than 5,000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
According to recommend USA EPA test and good laboratory practice (GLP) guidelines.

Acute toxicity: via inhalation route

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:
Aug 22, 2016 - Nov 24, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
OECD 402:1987
Deviations:
no
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
Vehicle:
olive oil
Duration of exposure:
24 hours
Doses:
2,000 mg/kg B.W. for the limited test
No. of animals per sex per dose:
for control group: six male and six female
for test group: six male and six female
Control animals:
yes, concurrent vehicle
Preliminary study:
In the pilot study, fixed doses of 50, 200, 1,000 and 2,000 mg/kg B.W. are used to select the treatment dose. The dose of Everlan SL65 didn't cause death in the rat, a limit test is conducted with the dose of 2,000 mg/kg B.W.
Key result
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

0.6

277.8

359.1

+81.3

02M

0.6

286.5

361.6

+75.1

03M

0.6

279.5

351.6

+72.1

04M

0.5

265.6

338.7

+73.1

05M

0.6

286.5

369.7

+83.2

06M

0.6

285.9

365.3

+79.4

Test

07M

0.5

262.6

369.5

+106.9

08M

0.6

279.6

363.8

+84.2

09M

0.5

271.1

346.2

+75.1

10M

0.6

275.9

356.4

+80.5

11M

0.5

269.3

337.0

+67.7

12M

0.6

305.8

388.4

+82.6

Control

13F

0.4

204.3

246.1

+41.8

14F

0.4

200.9

264.8

+63.9

15F

0.4

206.2

239.3

+33.1

16F

0.4

219.3

268.6

+49.3

17F

0.4

215.6

254.9

+39.3

18F

0.4

220.8

252.9

+32.1

Test

19F

0.4

200.1

236.4

+36.3

20F

0.4

209.5

242.5

+33.0

21F

0.4

213.5

248.9

+35.4

22F

0.4

220.5

252.0

+31.5

23F

0.4

222.0

263.6

+41.6

24F

0.4

214.1

244.7

+30.6

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 Everlan SL65 was greater than 2000 mg/kg B.W.. Therefore, Everlan SL65 was Category 5 based on GHS criteria.
Executive summary:

This test using the procedures outlined in the SuperLab for M62-151100100001EN which is based on the SOP (SOPP-342) for the OECD 402 and OECD 402 (OECD, 1987). Six male and six femaleSprague-Dawley rats for each group were used in limit test. For Test group, 12 Sprague-Dawley ratsweredermally dosed with 2000 mg/kg B.W. of Everlan SL65. 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 Everlan SL65 was 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 Everlan Brown EFR Dye Powder 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 Everlan Brown EFR Dye Powder was greater than 5,000 mg/kg.

 

Acute toxicity: via dermal route

Six male and six female Sprague-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 Everlan SL65. 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 Everlan SL65 was greater than 2,000 mg/kg B.W..

Justification for classification or non-classification