Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate

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)

Justification for type of information:

Data is from 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 below

Principles of method if other than guideline:

Acute oral toxicity study was conducted on male mice to determine LD50 value of chemical Carmoisine.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate

EC Number:

222-657-4

EC Name:

Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate

Cas Number:

3567-69-9

Molecular formula:

C20H12N2Na2O7S2

IUPAC Name:

disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate

Details on test material:

- IUPAC Name of test material: disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate
- Common Name: Carmoisine
- Molecular formula: C20H14N2O7S2.2Na
- Molecular weight: 502.4338 g/mole
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- IUPAC Name of test material: disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate
- Common Name: Carmoisine
- Molecular formula: C20H14N2O7S2.2Na
- Molecular weight: 502.4338 g/mole
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

mouse

Strain:

other: Sprague- Dawley white

Sex:

male

Details on test animals or test system and environmental conditions:

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
- Fasting period before study:
- 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%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs. Light: dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

not specified

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:

- 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
- mice in the control group received distilled water

Statistics:

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

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

4 166.66 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed.

Mortality:

50% mortality was observed.

Clinical signs:

other: The clinical signs such as, loss of appetite, drowsiness, tachycardia, decrease in locomotion and anorexia were distinctive signs observed in the mice before dead.

Gross pathology:

not specified

Other findings:

not specified

Any other information on results incl. tables

Determination of LD50 value of carmoisine in mice:

Dose	No.of mice in group	No. of death	Mean death	Dose difference	Mean death *dose diff.
1250 mg/kg	6	0	0	0	0
2500mg/Kg	6	0	0	1250	0
3750/mg/Kg	6	2	1	1250	1250
5000mg/kg	6	5	3.5	1250	4387
6250mg/kg	6	6	3.5	1250	6875
LD50 = LDy-Σ(Dd×md) /N = 6250 -12500/6 = 4166.66					12500

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute oral toxicity dose (LD50) was considered to be 4166.66 mg/kg bw, when male Sprague- Dawley white mice were treated with Disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate (CAS no: 3567-69-9) for 3 days via oral gavage route.

Executive summary:

Acute oral toxicity study was conducted in male Sprague-Dawley white mice by using test chemical disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1- sulfonate (CAS no: 3567-69-9) at the concentrations of 1250 mg/kg, 2500 mg/kg, 3750 mg/kg, 5000 mg/kg, 6250 mg/kg bw. 6 animals/dose were administered the given test chemical via oral gavage route and control animals were received distilled water. 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. The LD50 of the substances was calculated using the arithmetic method of Karber. 50% mortality was observed at 4166.66 mg/kg bw. The clinical signs such as, loss of appetite, drowsiness, tachycardia, decrease in locomotion and anorexia were distinctive signs observed in the mice before dead. Therefore, LD50 was considered to be 4166.66 mg/kg bw, when male Sprague- Dawley white mice were treated with Disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl] naphthalene-1-sulfonate for 3 days via oral gavage route.