Registration Dossier

Administrative data

Description of key information

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:
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
6810 mg/kg: prone position, trembling
Body weight:
decreased body weight gain in first study week
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

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:
no effect
Body weight:
no data
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