Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)

Endpoint summary

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..