Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Constituent 1
Chemical structure
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.