4,4'-dihydroxy-7,7'-iminodi(naphthalene-2-sulphonic acid)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

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 Handbook.

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Acute oral toxicity of Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] (72-57-1)

Author:

Richard J. Lewis, Sr.

Year:

2004

Bibliographic source:

Sax's Dangerous Properties of Industrial Materials. 11th Edition, p. 935, 2004.

Reference 2

Reference Type:

other: authoritative database

Title:

Acute oral toxicity of Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] (72-57-1)

Author:

Hazardous Substances Data Bank

Year:

2017

Bibliographic source:

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

Reference 3

Reference Type:

secondary source

Title:

Acute oral toxicity study prepared by food and Drug Research Laboratories Incorporated with cover letter

Author:

National Technical Reports Library

Year:

1972

Bibliographic source:

NTRL, Acute oral toxicity study prepared by food and Drug Research Laboratories Incorporated, OTS0215154, 1972

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as metioned below

Principles of method if other than guideline:

Acute oral toxicity of Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] (CAS no: 72-57-1 ) in rat.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]

EC Number:

200-786-7

EC Name:

Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]

Cas Number:

72-57-1

Molecular formula:

C34H28N6O14S4.4Na

IUPAC Name:

Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]

Details on test material:

- IUPAC Name: Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]
- Common Name: Trypan Blue
- Mol. formula: C34H24N6Na4O14S4
- Molecular Weight: 960.8156 g/mole
- Smiles: c12c(cc(c(c1O)/N=N/c1c(cc(cc1)c1cc(c(cc1)/N=N/c1c(cc3c(c1O)c(cc(c3)S(=O)(=O)[O-])N)S(=O)(=O)[O-])C)C)S(=O)(=O)[O-])cc(cc2N)S(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+]
- InChI: 1S/C34H28N6O14S4.4Na/c1-15-7-17(3-5-25(15)37-39-31-27(57(49,50)51)11-19-9-21(55(43,44)45)13-23(35)29(19)33(31)41)18-4-6-26(16(2)8-18)38-40-32-28(58(52,53)54)12-20-10-22(56(46,47)48)14-24(36)30(20)34(32)42;;;;/h3-14,41-42H,35-36H2,1-2H3,(H,43,44,45)(H,46,47,48)(H,49,50,51)(H,52,53,54);;;;/q;4*+1/p-4/b39-37+,40-38+;;;;

Specific details on test material used for the study:

- Name of test material (as cited in study report):Niagara Blue 3B
- Molecular formula (if other than submission substance):C34H24N6Na4O14S4
- Molecular weight (if other than submission substance):960.8156 g/mole
- Substance type:Organic
- Physical state:Dark Blue Powder
PurityNo data
- Impurities (identity and concentrations):No data

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: 24 hours
- Housing: No data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% W/V Suspension in Water.
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data

MAXIMUM DOSE VOLUME APPLIED:
- Rationale for the selection of the starting dose:

Doses:

4000, 5000, 6250 and 7900 mg/kg

No. of animals per sex per dose:

Total = 20 (Male/Female)
3 males and 2 females -4000 mg/kg
3 males and 2 females -5000 mg/kg
3 males and 2 females -6250 mg/kg
3 males and 2 females -7900 mg/kg

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

The mortality data were evaluated according to the Thompson Moving Average Method.

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

6 200 mg/kg bw

Based on:

test mat.

95% CL:

> 5 500 - < 6 900

Remarks on result:

other: 50% mortality was observed

Mortality:

At 4000 mg/kg – All animals were survived.
At 5 000 mg/kg – All animals were survived.
At 6250 mg/kg – 3 animals were died out of 5
At 7900 mg/kg – 5 animals were died out of 5

Clinical signs:

other: not specified

Gross pathology:

not specified

Other findings:

not specified

Any other information on results incl. tables

Table – The acute oral toxicity in rats

Dosage level ml/kg	Gm Equiv Dosage level gm/kg	No. of Rats Dosed	Day														Mortality After 14 Days
			1	2	3	4	5	6	7	8	9	10	11	12	13	14
16.0	4.0	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/5
20.0	5.0	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/5
25.1	6.25	5	3	0	0	0	0	0	0	0	0	0	0	0	0	0	3/5
31.6	7.9	5	5	0	0	0	0	0	0	0	0	0	0	0	0	0	5/5

 

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

LD50 was considered to be 6200 mg/kg at 19/20 Confidence Limits of 5500 - 6900 mg/kg bw, when Sherman-Wistar rat was treated with Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] orally.

Executive summary:

The acute oral toxicity study was conducted by using Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] in 4 groups of albino rats, consisting of 3 males and 2 females of the Sherman-Wistar rat at the concentration of 4000, 5000, 6250 and 7900 mg/kg. The test substance was in the form of Dark Blue Powder which dissolved at 25% W/V Suspension in Water (Vehicle). The animals were observed initially for a Acclimation period of 1 week to assure normalcy. The animals were then starved for 24 hours. Each animal administered given doses directly by gavage route. The animals were allowed food and water ad libitum during a 14 day observation period. The mortality data were evaluated according to the Thompson Moving Average Method. . The mortality data were evaluated according to the Thompson Moving Average Method. At 6250 gm/kg, 3 animals were died and at 7900 mg/kg all animals died. No mortality was observed at 4000, 5000 mg/kg. Therefore, LD50 was considered to be 6200 mg/kg at 19/20 Confidence Limits of 5500 - 6900 mg/kg bw, when Sherman-Wistar rat was treated with Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] orally.