Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate

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 publication.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Toxicity study of the given test chemical in Sprague-Dawley rats

Author:

Borzelleca et al.

Year:

1989

Bibliographic source:

Food and Chemical Toxicology

Reference 2

Reference Type:

publication

Title:

WHO Food Additives Series

Author:

WHO

Year:

2017

Bibliographic source:

World Health Organization

Reference 3

Reference Type:

publication

Title:

Toxicological Evaluation of Certain Food Additives

Author:

WHO

Year:

1980

Bibliographic source:

WHO

Reference 4

Reference Type:

review article or handbook

Title:

Acute oral toxicity of test chemical

Author:

Richard J. Lewis

Year:

2012

Bibliographic source:

Sax's Dangerous Properties of Industrial Materials

Reference 5

Reference Type:

other: authoritative database

Title:

Acute oral toxicity by using test chemical

Author:

U.S. National Library of Medicine

Year:

2018

Bibliographic source:

ChemIDplus

Reference 6

Reference Type:

other: authoritative database

Title:

Acute studies in rodents.

Author:

U.S. National Library of Medicine

Year:

2012

Bibliographic source:

HSDB

Reference 7

Reference Type:

other: secondary database

Title:

Robust Summaries and Test Plans

Author:

USEPA

Year:

2006

Bibliographic source:

HPV Challenge Program

Reference 8

Reference Type:

secondary source

Title:

Evaluation of the test chemical

Author:

EFSA

Year:

2009

Bibliographic source:

EFSA Journal

Reference 9

Reference Type:

publication

Title:

Acute oral toxicity of test chemical in rats

Author:

HPVIS

Year:

2018

Bibliographic source:

HPVIS,2018

Reference 10

Reference Type:

other: secondary source

Title:

OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS – Curry Red (Colipa n C174).

Author:

European Commission (EC) - Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP)

Year:

2004

Bibliographic source:

SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS – SCCP, Colipa n C174, SCCNFP/0791/04, 2004.

Reference 11

Reference Type:

other: secondary database

Title:

Toxicological Profiles - Test chemical

Author:

U.S. Consumer Product Safety Commission

Year:

1981

Bibliographic source:

NATIONAL TECHNICAL INFORMATION SERVICE

Reference 12

Reference Type:

other: secondary source

Title:

Acute oral toxicity

Author:

European Commission (EC) - Scientific Committee on Cosmetology (SCC)

Year:

1987

Bibliographic source:

European Commission (EC) - Scientific Committee on Cosmetology (SCC),1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of the given test chemical was performed in rat.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate

EC Number:

247-368-0

EC Name:

Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate

Cas Number:

25956-17-6

Molecular formula:

C18H16N2O8S2.2Na

IUPAC Name:

disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate

Details on test material:

- IUPAC Name: Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Common Name: Allura Red AC
- InChI: 1S/C18H16N2O8S2.2Na/c1-10-7-14(16(28-2)9-17(10)30(25,26)27)19-20-18-13-5-4-12(29(22,23)24)8-11(13)3-6-15(18)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);; /q;2*+1/p-2/b20-19+;;
- Smiles: c12c(cc(cc2)S(=O)(=O)[O-])ccc(c1/N =N/c1c(cc(c(c1)C)S(=O)(=O)[O-])OC)O. [Na+].[Na+]
- Molecular formula:C18H14N2Na2O8S2
- Molecular weight :496.4266 g/mole
- Substance type:organic
- Physical state:Solid, dark red in color

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: The animals were fasted for 3-4 hours prior to dosing.
- Housing: Following dosing, the animals were housed in metal cages suspended above the droppings.
- Diet (e.g. ad libitum): Food, ad libitum.
- Water (e.g. ad libitum): Water, ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10% W/V solution

Doses:

215, 464, 1000, 2150, 4640, and 10000 mg/kg bw

No. of animals per sex per dose:

Six groups of five male and five female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made immediately following dosing, at 1, 4, 24, 48 hours and once daily thereafter up to 14 days.
- Necropsy of survivors performed: yes, following the observation period, the animals were weighed, sacrificed by cerebral concussion and necropsied.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths at any dose level tested.

Clinical signs:

other: Clinical observations were normal with the exception of red colored feces in both sexes at all dose levels and red-colored urine at the three highest dose levels in the female animals.

Gross pathology:

not specified

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

Acute oral toxicity dose (LD50) value was considered to be >10000 mg/kg bw, when male and female Sprague-Dawley albino rats were treated with the given test chemical via oral gavage route.

Executive summary:

Acute oral toxicity study was conducted by using the given test chemical in male and female Sprague-Dawley albino rats at the dose concentrations of 215, 464, 1000, 2150, 4640, and 10000 mg/kg bw. Six groups of five male and five female Sprague-Dawley rats each were administered the test substance in a 10% weight/volume solution. The animals were fasted for 3-4 hours prior to dosing. Following dosing, the animals were housed in metal cages suspended above the droppings. Food and water were available ad libitum. Observations were made immediately following dosing, at 1, 4, 24, 48 hours and once daily thereafter up to 14 days. Following the observation period, the animals were weighed, sacrificed by cerebral concussion and necropsied. There were no deaths at any dose level tested. Clinical observations were normal with the exception of red colored feces in both sexes at all dose levels and red-colored urine at the three highest dose levels in the female animals. Under the condition of the study, the LD50 value was considered to be >10000 mg/kg bw, when male and female Sprague-Dawley albino rats were treated with the given test chemical via oral gavage route.