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: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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 authoritative database

Data source

Reference

Reference 1

Reference Type:

other: authoritative database

Title:

Acute inhalation 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:

US national Library of Medicine

Year:

2017

Bibliographic source:

HSDB (Hazardous Substances Data Bank); US national Library of Medicine,2017

Reference 2

Reference Type:

secondary source

Title:

Evaluation of the Acute Toxicity of Lumisol Blue VG (100 percent Conc.,Mix No.384)(TR No. 78-735)(Code No. 2146 00) in Rats

Author:

National Technical Reports Library

Year:

1979

Bibliographic source:

National Technical Reports Library, Fiche No. OTS0206237,1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute inhalation 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 rats.

GLP compliance:

not specified

Test type:

other: no data

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):LUMISOL BLUE VG
- Molecular formula :C32H20Cu2N6Na4O16S4
- Molecular weight :1087.82 g/mol
- Substance type:organic
- Physical state:Grey-black powder
- Purity :100%

Test animals

Species:

rat

Strain:

other: Holtzman Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Holtzman Co., Madison, Wisconsin
- Weight at study initiation: 289 and 521 grams
- Housing: The animals were housed two to three per individual wire mesh cages prior to and after the 4-hour exposure in rooms
- Diet (e.g. ad libitum):food was provided ad libitum
- Water (e.g. ad libitum):water was provided ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):24 ± 2° C
- Photoperiod (hrs dark / hrs light): a controlled light:dark (12 hr:12 hr) cycle

IN-LIFE DATES: From: May 23, 1979
To: June 6, 1979

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

not specified

Vehicle:

not specified

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: a stainless steel-glass chamber that-consists of a 72-liter, 22 x 20 x 10 inch cubical section with a pyramidal top and bottom
- Exposure chamber volume: approximately 150 liters
- Method of holding animals in test chamber:
- System of generating particulates/aerosols: Generation of the chemical dust and dispersion into the exposure chamber were accomplished by means of a direct dust-feed system that is operated by a blower motor located on the outlet side of the chamber.
- Method of particle size determination: Particle size analysis of the chemical dust atmosphere within the chamber was accomplished by drawing a measured volume of chamber air through dessicated pre-weighed glass fiber discs in an Andersen cascade impactor. The Andersen pump was operated at the recommended flow rate of 1 CFM (28.32 l/min).

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

11.71 mg/l (11710 mg/m3) in air

No. of animals per sex per dose:

Total:10 animals
11.71 mg/l:5 males and 5 females

Control animals:

not specified

Details on study design:

Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations: During the 14-day post-exposure period, daily examinations of surviving animals for latent effects were made by trained observers during the week.
Gross toxic signs, pharmacological effects or other abnormalities observed during these examinations were recorded.
All surviving animals were necropsied at 14 days post exposure, major organs were examined for macroscopic abnormalities and all abnormalities were recorded.
-Frequency of weighing: Body weights were obtained prior to exposure and at 1, 7 and 14 days after exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Statistics:

No data

Results and discussion

Preliminary study:

No data

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

11.71 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: No mortality was observed

Mortality:

no mortality was observed at dose 11.71 mg/l in air

Clinical signs:

other: No clinical signs occurred during the exposure

Body weight:

Body weights of males were normal, but 2 females exhibited slight depressed weight gain.

Gross pathology:

Necropsy findings found macroscopic lesions in the lungs of all animals.
These findings included hemorrhagic spots and foci, a purplish discoloration and rough texture of lobes or portions of lobes, and nodular masses or growths with a shrunken appearance. These findings were not considered treatment-related because it was concluded that these findings were typical of chronic murine pneumonia complex.
Other prominent abnormalities were nodular masses or growths, shrunken appearance and rough texture of lobes and white patches or areas.

Other findings:

no data

Any other information on results incl. tables

TABLE 1. Animals height

Animal no.	sex	Initial wt. (g) Date:5-23	1-day Wt.(g) Date:5-24	7-day Wt. (g) Date:5-30	14-day Wt. (g) Date:6-6
A58	M	462	463	495	516
A59	M	478	474	500	510
A60	M	479	481	498	510
A61	M	500	487	513	527
A62	M	521	520	548	556
A61	F	302	302	315	322
A62	F	284	296	309	315
A63	F	300	303	311	317
A64	F	318	319	319	333
A65	F	289	283	290	289

 

SUMMARY:

Animal body weight gainpatterns normal in the m,ales;in the females;two rats (A63,A64) had slightly depressed weight gain patterns and one (A55) showed no gain at the end of the 14-day post-exposure period.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The acute inhalation toxicity study in rats by using 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) for exposure of 4 hr was considered to be 11710 mg/m3 (11.71 mg/L).

Executive summary:

Ten Haltzman Sprague-Dawley rats (5 male, 5 female) were exposed for 4 hours in an inhalation chamber to the maximum obtainable concentration of Lumisol Blue VG (TR No. 78-735) powder. The powder was dispersed by an NBS dust generator into the stainless steel-glass chamber in which the 10 animals were housed individually in wire mesh cages. The nominal concentration of the chemical in the exposure atmosphere was calculated from the weighed quantity of chemical dispersed into the chamber and the total volume of air passed through the chamber.The animals were observed frequently during exposure and during the 14-day post-exposure period for pharmaco-toxic signs. Body weights were obtained prior to exposure and at 1, 7 and 14 days after exposure. At the end of the 14-day post-exposure period, all surviving animals were necropsied and major organs were examined for macroscopic abnormalities.No mortality was observed at dose 11.71 mg/l. No clinical signs occurred during the exposure. Body weights of males were normal, but 2 females exhibited slight depressed weight gain. Necropsyfindings found macroscopic lesions in the lungs of all animals.Thesefindings included hemorrhagic spots and foci, a purplish discoloration and rough texture of lobes or portions of lobes, and nodular masses or growths with a shrunken appearance. Thesefindings were not considered treatment-related because it was concluded that thesefindings were typical of chronic murine pneumonia complex. Other prominent abnormalities were nodular masses or growths, shrunken appearance and rough texture of lobes and white patches or areas.Hence, The acute inhalation toxicity study in rats by using 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)for exposure of 4 hr was considered to be 11710 mg/m3 (11.71 mg/L).