Registration Dossier
Registration Dossier
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EC number: 442-520-4 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 10th, 2002 to May 3rd, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- March 22nd,1996
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- September 30th, 1996
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Yellow 6314-PPT
- IUPAC Name:
- Yellow 6314-PPT
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Han/Brl
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- Dosage after 17-18 hours fasting, but free access to water. Food was provided again approximately 3 hours after dosing.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- No clinical signs were observed during the course of the study.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and age.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008).
- Conclusions:
- LD50 > 2000 mg/kg.
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