Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: BASF internal guideline followed

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
BASF-Testing method
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Handelsware Indigo rein BASF Pulver
- Substance type: active ingredient
- 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:
CMC (carboxymethyl cellulose)
Details on exposure:
2% 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
Dose descriptor:
LD50
Effect level:
ca. 8 000 mg/kg bw
Mortality:
no data
Clinical signs:
ataxia, dyspnea, blue discoloration of fur
Body weight:
no data
Gross pathology:
discoloration of organs, intraabdominal precipitation of TS, blunt liver margins, enlarged spleen

Applicant's summary and conclusion

Conclusions:
The intraperitoneal LD50 in the mouse is approximately 8000 mg/kg bw