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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:
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

Referenceopen allclose all

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 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 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

Constituent 1
Chemical structure
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.