Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1989 - March 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards and acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

other company data

Title:

Unnamed

Year:

1990

Report date:

1990

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

1982

Report date:

1982

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:

Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate

EC Number:

274-427-8

EC Name:

Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate

Cas Number:

70210-31-0

Molecular formula:

C43H30N8O14S4.4Na

IUPAC Name:

tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate

impurity 1

Reference substance name:

Colorless components

IUPAC Name:

Colorless components

Test material form:

solid: particulate/powder

Details on test material:

Other name: Saturnová nám. modř LFG konc. ; sample No. 196/89

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: 140 - 158g- 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:

water

Details on oral exposure:

VEHICLE - Concentration in vehicle: 20%MAXIMUM DOSE APPLIED: 10 g/kg

Doses:

7.943; 10.00, 12.59 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:

9 607 mg/kg bw

Based on:

test mat.

95% CL:

> 9 024 - < 10 230

Mortality:

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

Clinical signs:

1/2 hour after aplication both doses diarrhea - the symptom disappeared the next day; 3 hours after dose 10 g rats were languid;

Body weight:

not specified (initial weight 140 - 158g)

Gross pathology:

Coloring of tissues; necropsy after 14 days revealed colour in kidneys, liver and spleen for 10 g dose and for 7.9 dose in kidneys.

Any other information on results incl. tables

Dose[g/kg]	Mortality
7.943	0/10
10.000	7/10
12.59	10/10

LD50 = 9.607 (9.024 – 10.230) 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, Direct Blue 85 (Saturnová námořnická modř LFG konc.), for male rats is 9.607 g/kg of body weight.