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Acute Toxicity: oral

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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

Referenceopen allclose all

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 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 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
not specified
Body weight:
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.