Registration Dossier
Registration Dossier
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EC number: 207-586-9 | CAS number: 482-89-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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 or test system 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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
- 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 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: 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
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 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
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