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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 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

Constituent 1
Chemical structure
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:
No toxic effects were recorded in all the doses administered.
Body weight:
No data available
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.