4-[[5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-4,5-dihydro-5-oxo-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic 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 peer review publication.

Data source

Reference

Reference Type:

publication

Title:

Acute Toxicity of Food additives Tartrazine and carmoisine on white male Mice

Author:

Lamia A. M. Ai-Mashhedy, Ali N. Fijer

Year:

2016

Bibliographic source:

International Journal of Pharm Tech Research,Vol.9, No.4, pp 364-367, 2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as per mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate (1934-21-0) was conducted on white male mice.

GLP compliance:

no

Test type:

other: No data available

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

EC Number:

217-699-5

EC Name:

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

Cas Number:

1934-21-0

Molecular formula:

C16H12N4O9S2.3Na

IUPAC Name:

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

Details on test material:

- Name of test material (IUPAC name): Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Name of test material :Tartrazine
- Molecular formula:C16H12N4O9S2.3Na
- Molecular weight :534.3681 g/mol
- Smiles notation: n1(c2ccc(cc2)S(=O)(=O)[O-])c(c(c(n1)C(=O)[O-])/N=N/c1ccc(cc1)S(=O)(=O)[O-])O.[Na+].[Na+].[Na+]
-InChl:1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;;
- Substance type:Organic

Specific details on test material used for the study:

- Name of test material (IUPAC name): Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Name of test material :Tartrazine
- Molecular formula:C16H12N4O9S2.3Na
- Molecular weight :534.3681 g/mol
- Smiles notation: n1(c2ccc(cc2)S(=O)(=O)[O-])c(c(c(n1)C(=O)[O-])/N=N/c1ccc(cc1)S(=O)(=O)[O-])O.[Na+].[Na+].[Na+]
-InChl:1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;;
- Substance type:Organic

Test animals

Species:

mouse

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: college of science at the University of Babylon
- Age at study initiation:8-9 weeks old
- Weight at study initiation: 25-30 gm
- Housing: animals were housed in polyacrylic cages, not more than three animals per cage under standard laboratory condition
- Diet (e.g. ad libitum): standard diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2C°
- Humidity (%):50-55%
- Photoperiod (hrs dark / hrs light): 12 hrs. Light: dark cycle

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data available

Doses:

1250 mg/kg ,2500 mg/kg ,3750 mg/kg ,5000 mg/kg , 6250 mg/kg

No. of animals per sex per dose:

1250 mg/kg- 6 animals
2500 mg/kg-6 animals
3750 mg/kg-6 animals
5000 mg/kg-6 animals
6250 mg/kg-6 animals

Control animals:

yes

Details on study design:

Details on study design
- Duration of observation period following administration:3 days
- Frequency of observations and weighing:No data available
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The mice were observed for 3 days for the signs and symptoms of toxicity as well as the death rate of each group were recorded.

Statistics:

No data available

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 6 250 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed

Mortality:

No mortality was recorded at highest dose 6250 mg/kg BW.

Clinical signs:

other: No toxic effects were recorded in all the doses administered.

Gross pathology:

No data available

Other findings:

The LD50 of the substances was calculated using the arithmetic method of Karber
The LD50 was calculated using the following formula:
LD50 =LDy – Σ (Dd x md)/N
Where LDy =Highest dose (LD100)
N =Number of animals per group
Dd =Dose difference
Md =Mean dead

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The LD50 was considered to be >6250 mg/kg bw when male Sprague- Dawly white mice was treated with Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate (1934-21-0) for 3 days via oral route.

Executive summary:

Acute oral toxicity test was conducted in male Sprague- Dawly white mice using Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate (1934-21-0) at the dose concentration of 1250 mg/kg, 2500 mg/kg, 3750 mg/kg 5000 mg/kg, 6250 mg/kg to 6 animals per dose by oral route. Control animals received distilled water only. The mice were observed for 3 days for the signs and symptoms of toxicity as well as the death rate of each group were recorded. Test material administration at single dose has not been found to be any toxic effects even at higher dose used (6250 mg/Kg BW) at the same time there is no mortality or morbidity was recorded in all grouped animals. Hence, LD50 was considered to be >6250 mg/kg bw when male Sprague- Dawly white mice was treated with Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate for 3 days via oral route.