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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: USA EPA test

Test guideline 2

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

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

305-729-0

EC Name:

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

Cas Number:

95009-01-1

Molecular formula:

C18H9CuN6O10S.Na

IUPAC Name:

Reaction products of diazotized 4-aminobenzenesulfonic acid coupled with resorcinol subsequently coupled with diazotised 2-amino-4,6-dinitrophenol, copper (2+) complexes, sodium salts

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Everlan Brown EFR
- Substance type: Powder
- Composition of test material, percentage of components: -
- Sample is produced in 2004
- Storage condition of test material: Ambient

Specific details on test material used for the study:

- Name of test material: Everlan Brown EFR Dye Powder

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.