Reaction mass of disodium 2-({4-methyl-2-[(4-{[5-methyl-1-(2-sulfonatophenyl)hexan-3-yl]amino}-9,10-dioxo-9,10-dihydroanthracen-1-yl)methyl]pentyl}amino)benzene-1-sulfonate,disodium 4-{5-methyl-3-[(4-{[5-methyl-1-(4-sulfonatophenyl)hexan-3-yl]amino}-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]hexyl}benzene-1-sulfonate anddisodium 4-{5-methyl-3-[(4-{[5-methyl-1-(2-sulfonatophenyl)hexan-3-yl]amino}-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]hexyl}benzene-1-sulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [(9,10-dihydro-9,10-dioxo-1,4-anthrylene)bis[imino[3-isopropylpropane-1,3-diyl]]]bis(benzenesulphonate)

EC Number:

276-822-0

EC Name:

Disodium [(9,10-dihydro-9,10-dioxo-1,4-anthrylene)bis[imino[3-isopropylpropane-1,3-diyl]]]bis(benzenesulphonate)

Cas Number:

72749-90-7

Molecular formula:

C40H46N2O8S2.2Na

IUPAC Name:

Disodium [(9,10-dihydro-9,10-dioxo-1,4-anthrylene)bis[imino[3-isopropylpropane-1,3-diyl]]]bis(benzenesulphonate)

Test material form:

solid: particulate/powder

Details on test material:

Acid Blue 221

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

Application volume: 20 to 30 mL/kg bw

Doses:

6, 7, 8, 9 and 10 g/kg bw

No. of animals per sex per dose:

10 males/dose group

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

Probit-Analyse (Fink und Hund, Arzneimittelforsch. 15, 1965, 624)

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

7 646 mg/kg bw

Based on:

test mat.

95% CL:

6 731 - 8 488

Mortality:

mortality occured within 7h to 3 days after application

Clinical signs:

hypoactivity, prone position, diarrhea, piloerection

Body weight:

no data

Gross pathology:

no data

Any other information on results incl. tables

dose [g/kg bw]	dead /treated animals
6	2/10
7	3/10
8	5/10
9	9/10
10	8/10

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD 50 for male wistar rates was determined to be 7646 mg/kg bw under the conditions of the test. The substance is not classifiable according to CLP criteria.