Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer-reviewed journal

Data source

Reference

Reference 1

Reference Type:

other: authoritative database

Title:

Acute oral toxicity study of Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) in rat

Author:

U.S. National Library of Medicine

Year:

2017

Bibliographic source:

Chemidplus Database,U.S. National Library of Medicine,2017

Reference 2

Reference Type:

review article or handbook

Title:

Acute oral toxicity study of Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) in rat

Author:

S. Gangolli

Year:

1999

Bibliographic source:

The Dictionary of Substance and their effects,2nd edition,vol.2 (part 6)

Reference 3

Reference Type:

secondary source

Title:

Acute Oral Toxicity Study

Author:

National Technical Reports Library

Year:

1972

Bibliographic source:

National Technical Reports Library, Fiche No. OTS 215154,1972

Reference 4

Reference Type:

secondary source

Title:

Acute oral toxicity study of Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) in rat

Author:

RTECS

Year:

2018

Bibliographic source:

RTECS (registry of toxic effect of chemical substance database ), 2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute Oral toxicity test was carried out to study the effects of Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) on rats.

GLP compliance:

not specified

Test type:

other: no data available

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)

EC Number:

249-008-8

EC Name:

Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)

Cas Number:

28407-37-6

Molecular formula:

C32H16Cu2N6O16S4.4Na

IUPAC Name:

Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)

Details on test material:

- Name of test material (IUPAC name): Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI)
- Common name: Direct Blue 218
- Molecular formula: C32H20Cu2N6Na4O16S4
- Molecular weight: 1087.82 g/mol
- Smiles notation: c12c3c(c(S(=O)(=O)[O-])cc1cc(S(=O)(=O)[O-])cc2N)N=Nc1ccc(cc1O[Cu]O3)c1cc2c(N=Nc3c(cc4c(c3O[Cu]O2)c(cc(c4)S(=O)(=O)[O-])N)S(=O)(=O)[O-])cc1.[Na+].[Na+].[Na+].[Na+]
- InChl: 1S/C32H24N6O16S4.2Cu.4Na/c33-19-11-17(55(43,44)45)5-15-9-25(57(49,50)51)29(31(41)27(15)19)37-35-21-3-1-13(7-23(21)39)14-2-4-22(24(40)8-14)36-38-30-26(58(52,53)54)10-16-6-18(56(46,47)48)12-20(34)28(16)32(30)42;;;;;;/h1-12,39-42H,33-34H2,(H,43,44,45)(H,46,47,48)(H,49,50,51)(H,52,53,54);;;;;;/q;2*+2;4*+1/p-8/b37-35-,38-36-;;;;;;
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material (as cited in study report):Solantine Blue 10GL
- Molecular formula :C32H20Cu2N6Na4O16S4
- Molecular weight :1087.82 g/mol
- Substance type:organic

Test animals

Species:

rat

Strain:

other: Albino SASCO

Sex:

male/female

Details on test animals or test system and environmental conditions:

Details on test animal
TEST ANIMALS
- Weight at study initiation: 190 to 304 grams
- Fasting period before study: the animals were fasted overnight
- Housing: The animals were individually housed in metal, wire-bottomed cages elevated above the droppings.
- Diet (e.g. ad libitum): Purina Laboratory Chow was provided ad libitum
- Water (e.g. ad libitum): water was provided ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: deionized water

Details on oral exposure:

Details on exposure
VEHICLE
- Amount of vehicle (if gavage): 50% w/w
MAXIMUM DOSE VOLUME APPLIED: 6330 mg/kg bw

DOSAGE PREPARATION (if unusual):test substance was soluble in deionized water

Doses:

2520, 3170, 3990, 5020 and 6330 mg/kg bw

No. of animals per sex per dose:

Total: 25 animals

Control animals:

not specified

Details on study design:

Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations :
Gross pathology: The animals were observed for gross effect at regular intervals on the day of dosing and daily thereafter for 14 days.
- Frequency of weighing: Following the observation period, all surviving animals were weighed.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

The acute oral LD50 calculated by the method of Weil, C.S.

Results and discussion

Preliminary study:

Preliminary test:
the actual LD50 determination, exploratory doses were administered to six rats to estimate the order of toxicity of the test material. Based on the results of the preliminary assay, groups of five rats were dosed at levels designed to blanket the toxicity range as follows: 2520, 3170, 3990, 5020 and 6330 mg/kg bw.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 290 mg/kg bw

Based on:

test mat.

95% CL:

2 720 - 3 980

Remarks on result:

other: 50% mortality was observed

Mortality:

50% mortality was observed at dose 3290 mg/kg bw in treated animals

Clinical signs:

other: the following clinical signs of toxicity were observed Prostration, labored breathing, proneness, malaise, blue-black diarrhea, ptosis, morbidity, lethargy and weakness. These appeared between 45 minutes and 6 hours after dosing .Surviving animals were n

Gross pathology:

Gross necropsy of animals which succumbed showed generalized congestion of the lung,liver, kidneys and adrenal glands.
In all animals, tissues from all major organ systems and muscles were dyed blue to green by the compound. The color level was dose dependent. This dying effect was observed in muscle- and tendon.
Gross necropsy of animals sacrificed at termination showed no tissue damage from the administration of the compound except at the 5020 mg/kg body weight dosage. The two animals surviving at this level showed some gross indication of liver damage.

Other findings:

no data

Any other information on results incl. tables

Table 1: Time of Death Following Dosage

Dosage Level gm/kg

(Days)

% mortality

1

2

3

4

5

6

7

8

9

10

11

12

13

14

2.52

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0

3.17

0/5

1/5

1/5

1/5

1/5

1/5

1/5

1/5

1/5

1/5

2/5

2/5

2/5

2/5

40

3.99

0/5

2/5

4/5

4/5

4/5

4/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

100

5.02

0/5

2/5

3/5

3/5

3/5

3/5

3/5

3/5

3/5

3/5

3/5

3/5

3/5

3/5

60

6.33

0/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

5/5

100

*Specific gravity = 1.299 at 23° Centigrade

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The lethal concentration (LD50) value for acute oral toxicity test was considered to be 3290 mg/kg bw,when male and female albino SASCO rats were treated with Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) orally via gavage.

Executive summary:

Acute oral toxicity study was done in Male and female albino SASCO rats (SASCO strain) weighing 190 to 304 grams .Each animal was examined and only healthy animals were used on this study. The animals were individually housed in metal, wire-bottomed cages elevated above the droppings.Prior to dosing, the animals were fasted overnight.food and water was provided ad libitum.Prior to the actual LD50 determination, exploratory doses were administered to six rats to estimate the order of toxicity of the test material. Based on the results of the preliminary assay, groups of five rats were dosed at levels designed to blanket the toxicity range as follows: 2520, 3170, 3990, 5020 and 6330 mg/kg bw.The test material was prepared as a 50% weight/weight dilution indeionized water. The animals were observed for gross effect at regular intervals on the day of dosing and daily thereafter for 14 days. Animals which succumbed were necropsied. Following the observation period, all surviving animals were weighed, sacrificed and necropsied. The following clinical signs of toxicity were observed Prostration, labored breathing, proneness, malaise, blue-black diarrhea, ptosis, morbidity, lethargy and weakness. These appeared between 45 minutes and 6 hours after dosing .Surviving animals were normal within 6 days after dosing. Final bodyweight records of survivors at termination showed weight gains within expected limits except in one animal at the 5020 mg/kg body weight level which showed no gain. Gross necropsy of animals which succumbed showed generalized congestion of the lung,liver, kidneys and adrenal glands. In all animals, tissues from all major organ systems and muscles were dyed blue to green by the compound. The color level was dose dependent. This dying effect was observed in muscle- and tendon.Gross necropsy of animals sacrificed at termination showed no tissue damage from the administration of the compound except at the 5020 mg/kg body weight dosage. The two animals surviving at this level showed some gross indication of liver damage.Hence, Thelethal concentration (LD50) valuefor acute oral toxicity testwas considered to be3290mg/kg bw,when male and female albino SASCO rats were treated with Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) orally via gavage.