Benzoic acid, 5-[(4-aminophenyl)azo]-2-hydroxy-, reaction products with 3-[(4-amino-3-methoxyphenyl)azo]benzenesulfonic acid and carbonic dichloride, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May - August 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards and acceptable for assessment

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

- Principle of test: equivalent or similar to a standard acute method- Parameters analysed / observed: mortality and clinical signs of intoxication

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid, 5-[(4-aminophenyl)azo]-2-hydroxy-, reaction products with 3-[(4-amino-3-methoxyphenyl)azo]benzenesulfonic acid and carbonic dichloride, sodium salts

EC Number:

232-339-7

EC Name:

Benzoic acid, 5-[(4-aminophenyl)azo]-2-hydroxy-, reaction products with 3-[(4-amino-3-methoxyphenyl)azo]benzenesulfonic acid and carbonic dichloride, sodium salts

Cas Number:

8005-52-5

Molecular formula:

C27H22N6O8S.2Na

IUPAC Name:

hexasodium 2-hydroxy-5-[(1E)-2-{4-[({2-methoxy-4-[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]phenyl}carbamoyl)amino]phenyl}diazen-1-yl]benzoate 3-[(1E)-2-{3-methoxy-4-[({2-methoxy-4-[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]phenyl}carbamoyl)amino]phenyl}diazen-1-yl]benzene-1-sulfonate 5-[(1E)-2-{4-[({4-[(1E)-2-(3-carboxylato-4-hydroxyphenyl)diazen-1-yl]phenyl}carbamoyl)amino]phenyl}diazen-1-yl]-2-hydroxybenzoate

impurity 1

Reference substance name:

Sodium chloride

EC Number:

231-598-3

EC Name:

Sodium chloride

Cas Number:

7647-14-5

Molecular formula:

ClNa

IUPAC Name:

sodium chloride

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: not specified- Age at study initiation: not specified- Weight at study initiation: 115 - 150g- Fasting period before study: not specified- Housing: individually in cage - Diet (e.g. ad libitum): not specified- Water (e.g. ad libitum): not specified- Acclimation period: not specifiedENVIRONMENTAL CONDITIONSnot specified (laboratory conditions)

Administration / exposure

Route of administration:

other: unspecified, probably gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE- Concentration in vehicle: 20%MAXIMUM DOSE APPLIED: 15.85 g/kg

Doses:

10.00; 12.59; 15.85 g/kg

No. of animals per sex per dose:

10

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

15 270 mg/kg bw

Based on:

test mat.

95% CL:

> 13 490 - < 17 290

Mortality:

yes ( see Any other information on results ...)

Clinical signs:

other: not specified

Gross pathology:

not specified

Any other information on results incl. tables

Dose[g/kg]	Mortality
10.00	0/10
12.59	1/10
15.85	6/10

LD50 = 15.27 (13.49 – 17.29) g/kg b.w.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

very slightly toxic

Executive summary:

The test substance toxicity was evaluated on the basis of mortality and clinical signs of intoxication. According to the study results the value of LD50 of the test substance, Saturnová žluť L4G (Direct Yellow 44), for male rats is 15.27 g/kg of body weight.