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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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