Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study report in brief, but sufficient information aviailable to be taken for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Single oral application of 1000 and 5000 mg/kg bw Nigrosin WLF to groups of 10 female Wistar rats dissolved in water and observed over a period of 14 daxs for clinical signs and mortality.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
IUCLID4 Test substance: other TS
commercial formulation, purity ca. 99 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation:150-200 g
- Diet ad libitum
- Water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Single oral application of 1000 and 5000 mg/kg bw Nigrosin WLF to groups of 10 female Wistar rats dissolved in water and observed over a period of 14 daxs for clinical signs and mortality.
Doses:
1000 or 5000 mg/kg bw
No. of animals per sex per dose:
10 per dose group
Control animals:
no
Details on study design:
Single oral application of 1000 and 5000 mg/kg bw Nigrosin WLF to groups of 10 female Wistar rats dissolved in water and observed over a period of 14 daxs for clinical signs and mortality. Results evaluated by Probit-analysis according to Fink and Hund, arneimittelforschung 15, 1965
Statistics:
Results are evaluated by Probit-analysis according to Fink and Hund, Arzneimittelforschung 15, 1965

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: no mortality, fo clinical findings
Mortality:
no animal died
Clinical signs:
mo clinical signs wre observed
Body weight:
mean body weight development was not affected by treatment
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

An acute oral toxicity study is available with single oral application of 1000 and 5000 mg/kg bw Nigrosin WLF to groups of 10 female Wistar rats dissolved in water and observed over a period of 14 days for clinical signs and mortality. No animal died , no clinical signs were observed and body weight development was not affected by treatment. Thus the LD50 is >5000 mg/kg bw