Registration Dossier

Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
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: Study according to internal BASF standards

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-Testing method
GLP compliance:
no

Test material

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

Test animals

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

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
0.1% to 30% concentration in vehicle
Doses:
no data
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: no data
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 30 mg/kg bw
Mortality:
no data
Clinical signs:
ataxia, dyspnea, tremor
Body weight:
no data
Gross pathology:
intraabdominal precipitation of TS

Applicant's summary and conclusion

Conclusions:
The intraperitoneal LD50 in the mouse is approximately 30 mg/kg bw. As the intraperitoneal LD50 of indigo powder proved to be approximately 8000 mg/kg bw, the significantly lower dermal LD50 of Indigoküpe 60% Körner is most likely due to the 5% alkali content.