Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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 authoritative database

Data source

Reference

Reference 1

Reference Type:

other: authoritative database

Title:

Acute oral toxicity study of C.I. Acid Red 151 (CAS NO: 6406-56-0) in rat

Author:

U.S. National Library of Medicine

Year:

2017

Bibliographic source:

Chemidplus Database,U.S. National Library of Medicine,2017

Reference 2

Reference Type:

other: authoritative databse

Title:

Acute oral toxicity study of C.I. Acid Red 151 (CAS NO: 6406-56-0) in rat

Author:

RTECS

Year:

2017

Bibliographic source:

RTECS (registry of toxic effect of chemical substance data base ), 2017

Reference 3

Reference Type:

secondary source

Title:

INITIAL SUBMISSION: ACUTE ORAL TOXICITY OF C.I. ACID RED 151 WITH COVER LETTER DATED 090292

Author:

NTRL

Year:

1992

Bibliographic source:

NTRL NO: OTS0571003, 09/03/92

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The acute oral L50 test of C.I. Acid Red 151(CAS NO: 6406-56-0) in ChR-CD male rat.

GLP compliance:

not specified

Test type:

other: no data available

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate

EC Number:

229-029-9

EC Name:

Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate

Cas Number:

6406-56-0

Molecular formula:

C22H16N4O4S.Na

IUPAC Name:

sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate

Details on test material:

- Name of test material (IUPAC name): Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate
- Common name: Acid Red 151
- Molecular formula: C22H15N4O4S.Na
- Molecular weight: 455.448 g/mol
- Smiles notation: c12c(\N=N\c3ccc(\N=N\c4ccc(S(O)(=O)=O)cc4)cc3)c(ccc1cccc2)O.[Na+]
-InChl:1S/C22H16N4O4S.Na/c27-21-14-5-15-3-1-2-4-20(15)22(21)26-25-17-8-6-16(7-9-17)23-24-18-10-12-19(13-11-18)31(28,29)30;/h1-14,27H,(H,28,29,30);/q;+1/b24-23+,26-25+;
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material (as cited in study report):C.I. Acid Red 151
- Molecular formula :C22H15N4O4S.Na
- Molecular weight :455.448 g/mol
- Substance type:Organic
- Physical state:Solid
-Purity70% (22% Active Ingredient;35% 2-Ethoxyethanol;2% ''Merpol" DA;1% Compound 85;5% "Pluronic" L 42;5% NaOH)
- Impurities (identity and concentrations):30%

Test animals

Species:

rat

Strain:

other: ChR-CD

Sex:

male

Details on test animals or test system and environmental conditions:

Details on test animal:
TEST ANIMALS
- Age at study initiation:young and adult rats were used

Administration / exposure

Route of administration:

other: Oral (intragastric intubation)

Vehicle:

water

Details on oral exposure:

No data available

Doses:

7500, 8000, 8500 and 9500 mg/kg bw

No. of animals per sex per dose:

Total:40 animals
7500 mg/kg bw: 10 male
8000 mg/kg bw: 10 male
8500 mg/kg bw: 10 male
9500 mg/kg bw: 10 male

Control animals:

not specified

Details on study design:

Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

The LD50 value was calculated from the mortality data using the method of D. J. Finney.

Results and discussion

Preliminary study:

no data available

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

7 736 mg/kg bw

95% CL:

7 347 - 7 977

Remarks on result:

other: 50% mortality was observed

Mortality:

At 7500 mg/kg bw – 2/10 rats died
At 8000mg/kg bw – 9/10 rats died.
At 8500 mg/kg bw – 9/10 rats died.
At 9500 mg/kg bw – 10/10 rats died.

Clinical signs:

other: Belly-to-cage posture, eyes half closed, prostration, pallor, stained mouth and compound and/or metabolite(s) in feces after dosing at 9,500 mg/kg. Belly-to-cage posture, eyes half closed, lethargy, prostration, labored breathing, stained nose and mouth,

Gross pathology:

No data available

Other findings:

No data available

Any other information on results incl. tables

Dose(mg/kg)	Average Body Weight (g)	Mortality ratio
7500	267	2/10
8000	256	9/10
8500	266	9/10
9500	244	10/10

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The acute oral LD50 value of C.I. Acid Red 151 is considered to be 7,736 mg/kg (95% Confidence Limits:7347 mg/kg bw -7977 mg/kg bw) in ChR-CD male rats when test material was administered by intragastric intubation following 14 days of observation period.

Executive summary:

 Acute oral toxicity (LD50) test ofC.I. Acid Red 151was conducted in ChR-CD male rat.Test substancewas administered 7500, 8000, 8500 and 9500 mg/kg by intragastric intubation to four groups of ten rat. After 14 days observation.Mortality observed were 2/10 at dose 7500 mg/kg; 9/10 at 8000 and 8500 mg/kg and all animals died at dose 9500 mg/kg bw. clinical signs were observed at different doses which are as follows:Belly-to-cage posture, eyes half closed, prostration, pallor, stained mouth and compound and/or metabolite(s) in feces after dosing at 9,500 mg/kg.Belly-to-cage posture, eyes half closed, lethargy, prostration, labored breathing, stained nose and mouth, stained and wet perineal &rea and weight loss after dosing at 8,500 mg/kg.Belly-to-cage posture, eyes half closed, lethargy, prostration, chromodacryorrhea, irregular breathing, labored creathing, stained nose and mouth, stained and wet perineal area and weight loss after dosing at 8,000 mg/kg. Therefore,the acute oral L50 value ofC.I. Acid Red 151(95% Confidence Limits:7347 mg/kg bw -7977 mg/kg bw) is considered to be7,736 mg/kg in male ChR-CD rat.