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Registration Dossier
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EC number: 426-400-9 | CAS number: 170222-39-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 16 to October 30, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Red RA 10463
- IUPAC Name:
- Red RA 10463
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:(WI) BR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female animals
- Control animals:
- not specified
- Details on study design:
- - Observation period: 14 days post-administration
- Observations: body weight (weekly), clinical signs (daily), mortality (daily), macroscopic examination (necropsy)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Black staining of the back, tail, tail base, anus in all animals (males: day 2 onwards, until termination in 1 male only; females: day 5 to day 8-9). No clinical signs of toxicity were apparent.
- Gross pathology:
- No abnormal findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 (oral, rat) > 2000 mg/kg bw
LD0 ≥ 2000 mg/kg bw
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