Registration Dossier

Toxicological information

Acute Toxicity: dermal

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
BASF Method
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Indigoküpe BASF 60% Körner

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

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

Results and discussion

Preliminary study:
NA
Effect levels
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

Applicant's summary and conclusion

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