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

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Principles of method if other than guideline:

BASF method

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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: -

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

Preliminary study:

NA

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

4 430 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 000 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study according to internal BASF standards

Principles of method if other than guideline:

BASF Method

GLP compliance:

no

Test type:

standard acute method

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

no data

Type of coverage:

not specified

Vehicle:

water

Details on dermal exposure:

50% aqueous suspension

Duration of exposure:

no data

Doses:

2500 mg/kg bw

No. of animals per sex per dose:

no data

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: -
- Necropsy of survivors performed: yes

Statistics:

NA

Preliminary study:

NA

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Mortality:

no deaths

Clinical signs:

other: no effect

Gross pathology:

no effect

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

acute dermal LD50 in rats is higher than 2500 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Additional information

The LD₅₀ in several acute oral toxicity studies in rats with indigo Küpe (Grains) was reported as > 2000, 4430, or > 5000 mg/kg body weight.

The LD₅₀ in several acute oral toxicity studies in rats with indigo was reported as > 3160, > 5000, or > 6400 mg/kg body weight. These studies were non-GLP or GLP studies.

LC₅₀ and LD₅₀ values in acute inhalation and dermal toxicity studies with indigo in rats are > 5.3 mg/L/4 hrs and > 2500 mg/kg, respectively.

The LD₅₀ for intraperitoneally administered indigo in mice was approximately 8000 mg/kg.

Justification for classification or non-classification

Test substance is practically non-toxic with different administration routes