Registration Dossier
Registration Dossier
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EC number: 291-454-0 | CAS number: 90411-76-0
Acute Toxicity: oral
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:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
- EC Number:
- 291-454-0
- EC Name:
- Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
- Cas Number:
- 90411-76-0
- Molecular formula:
- Mixture of components, no definitve molecular formula existing.
- IUPAC Name:
- Complex mixture of phenazine dyes - IUPAC name not available
- Test material form:
- other: solid
- Details on test material:
- IUCLID4 Test substance: other TS
commercial formulation, purity ca. 99 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system 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:
- other: mo clinical signs wre observed
- 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
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