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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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP study; Comparable to guideline study; limited information on test itemand its formulation and animal husbandry. Test are in concordance with those recommended by the ETAD. The study results are considered valid for indigo.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
no data
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of clinical signs and mortality: daily
- Necropsy of survivors performed: yes
- Other examinations performed: histopathology
Statistics:
Logit analysis for LD50 calculation
Preliminary study:
NA
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
no deaths occurred
Clinical signs:
no effects
Body weight:
NA
Gross pathology:
no effects
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of Indigo N Lumps is above 5000 mg/kg bw in male and females rats. The test item has not to be labelled.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
5 000 mg/m³

Acute toxicity: via dermal route

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Reference
Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: BASF internal guideline followed. The test substance is the reduced form of the registered substance. Indigo Vat sodium salt oxidizes rapidly to indigo in the pressence of water and airborne oxygen.
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 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: clinical signs daily, weighing weekly
- 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
2 500 mg/kg bw

Additional information

The LD50in 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.

LC50and LD50values in acute inhalation and dermal toxicity studies with indigo in rats are > 5.3 mg/L/4 hrs and > 2500 mg/kg, respectively.

The LD50for 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