Registration Dossier
Registration Dossier
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EC number: 916-603-5 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 423 in compliance to GLP.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
- Reference Type:
- other: Published secondary source
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Multi constituent substance
- EC Number:
- 916-603-5
- IUPAC Name:
- Multi constituent substance
- Details on test material:
- Test substance : Basic Red 76 (COLIPA number C008)
Batch number : 0050644101
Methylsulphate anion : 11.8%
Chloride ion : 1.6%
Water : 5.1%
o-Anisidine : 5ppm
Purity : 98.1% (HPLC)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Three animals per sex per dose
- Control animals:
- no
- Details on study design:
- The test item was administered by oral gavage to a group of three female Wistar rats and then to a group of three male Wistar rats at a dose of 2000 mg/kg bw. The animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after sacrifice on day 15.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Hunched posture was observed in one female and 3 males on day 1. Red staining of the back and/or head was noted in one female and two males between days 1 and 11. Red and/or yellow faeces and/or yellow urine were observed in the animals on day 2 and/or da
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the LD50 of the test item was established to be >2000 mg/kg bw. The substance is not classified.
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