Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt

EC Number:

279-256-2

EC Name:

Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt

Cas Number:

79771-28-1

Molecular formula:

C52H38Cl2N16O24S6.6Na

IUPAC Name:

Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Everzol SB26
- Substance type: Powder
- Composition of test material, percentage of components: 78.12%
- Lot/batch No.: 3540
- Storage condition of test material: Ambient

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: No adverse effects

Any other information on results incl. tables

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.			Mortality^1) (%)
	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 7^2)	Day 14^3)
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 7^thday = (7^th-0^th) BW (g).

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

Applicant's summary and conclusion

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.