Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-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 a peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Acute (mouse and rat) and short-term (rat) toxicity studies on chocolate brown HT

Author:

D. E. Hall, F. S. Lee and F. A. Fairweather

Year:

1966

Bibliographic source:

Food and Cosmetics Toxicology Volume 4, 1966, Pages 143–149

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Aqueous solutions of Chocolate Brown HT in a dose volume of 10 ml/kg were administered to groups of 10 mice by oral intubation. Survivors were observed and number of deaths noted for 14 days.

GLP compliance:

not specified

Test type:

other: No data available

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate

EC Number:

224-924-0

EC Name:

Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate

Cas Number:

4553-89-3

Molecular formula:

C27H20N4O9S2.2Na

IUPAC Name:

disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Disodium 4,4’-(2,4-dihydroxy-5- hydroxymethyl-1,3-phenylene bis-azo) di- (naphthalene-1-sulfonate)
- Molecular formula: C27H20N4O9S2.2Na
- Molecular weight: 654.58 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

mouse

Strain:

other: Evans Albino

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: 16-20 g
- Fasting period before study: 18 hrs
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Aqueous solutions of Chocolate Brown HT in a dose volume of 10 ml/kg were administered.

Doses:

upto 2000 mg/kg

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: yes/no
- Other examinations performed: mortality, clinical signs, urine analysis
other:

Statistics:

The acute LD50 value was calculated by the method of Litchfield & Wilcoxon (1949)

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death observed during the observation period

Clinical signs:

other: Brown coloration especially of the extremities was observed

Gross pathology:

No data available

Other findings:

Elimination of orally-administered Chocolate Brown HT proceeded slowly, as evidenced by the persistence of brown colouring in the urine after a single dose

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) for the substance Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate is determined to be > 2000 mg/Kg in female Evans albino mice.

Executive summary:

Acute toxicity study was conducted on 10 female Evans albino mice for the test material Chocolate Brown HT ( Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate). Aqueous solution of the test material was administered at a dose volume of 10mL/Kg to the mice by oral intubation. On the basis of mortality, clinical signs observed and urinalysis performed, the LD50 for the given test material is determined to be >2000 mg/Kg. This value indicates that the substance is non-toxic by oral route as per the CLP criteria.