Disodium [2,2'-bi-1H-indole]-3,3'-diolate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15. May to 27 June 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles; leucoindigo in 1.5% NaOH solution forming the sodium salt CAS 894-86-0

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

BASF method

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [2,2'-bi-1H-indole]-3,3'-diolate

EC Number:

212-974-6

EC Name:

Disodium [2,2'-bi-1H-indole]-3,3'-diolate

Cas Number:

894-86-0

Molecular formula:

C16H12N2O2.2Na C16H10N2Na2O2

IUPAC Name:

disodium 1H,1'H-[2,2'-biindole]-3,3'-bis(olate)

Details on test material:

- Name of test material: 3,3'-Dihydroxydiindolyl-2,2'-dinatriumsalz in Lösung ber. 100%
- Substance type: preparation
3,3'-Dihydroxydiindolyl-2,2'-dinatriumsalz als ca 23%ige Lösung in ca 1.5%iger wässriger Natronlauge
- Physical state: liquid
- Lot/batch No.: 79/38
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hagemann
- Age at study initiation: 5 to 8 weeks
- Weight at study initiation: males: ca. 198 g; females: ca 170 g
- Fasting period before study: 15 to 20 hours
- Housing: -
- Diet: Herilan MRH-Haltung; H. Eggersmann KG ad libitum
- Water: tap water ad libitum
- Acclimation period: -

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 31.6, 38.3, 50%
- Amount of vehicle (if gavage): 10 and 13.6 mL/kg

Doses:

3160, 3830, 5000, 6810 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: 1 hour after dosing, Day 1, 2, 7, 14
- Body weight: Day 1, 2-4, 7, 13
- Necropsy of survivors performed: yes

Statistics:

NA

Results and discussion

Preliminary study:

NA

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 430 mg/kg bw

95% CL:

3 838 - 5 176

Mortality:

3160 mg/kg: no deaths occurred
3830 mg/kg: 2 males, 2 females
5000 mg/kg: 2 males, 3 females
6810 mg/kg: 5 males, 5 females

Clinical signs:

other: 3160 to 6810 mg/kg: dyspnea, lethargy, wobbling, compulsive nibbling, poor general condition 3160 + 3830 mg/kg: stertorousness 3160 + 5000 mg/kg: yellow-green urine 3160 mg/kg: blue feces 5000 mg/kg: spastic gait, shaggy fur, adhered eyelids and muzzle 68

Gross pathology:

died animals: heart acute dilation, acute congestive hyperemia; GI tract: discolored mucosa; stomach: atonic, liquid content, indured mucosa; intestines: minimally atonic, liquid content; organs and muscles: minimally bluish discolored
euthanized animals: stomach: wart-like buttons in forestomach, bulging swelling of the margo plicatus; singular adhesions of forestomch and liver

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of the test substance 3,3'-Dihydroxydiindolyl-2,2'-dinatriumsalz in Lösung ber. 100% in rats was calculated to be 4432 mg/kg bw.