Registration Dossier
Registration Dossier
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EC number: 436-000-6 | CAS number: 159010-67-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 13th to March 6th, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Blue REg 6080
- IUPAC Name:
- Blue REg 6080
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanBrl
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- clipped area on the back of animals corresponding to ca. 10 % of total body surface
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- observations up to 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
- Clinical signs:
- other: MORTALITY: no deaths occured during the study. CLINICAL SIGNS: no clinical signs of toxicity observed during the study. BODY WEIGHTS: no changes on body weights noted.
- Gross pathology:
- Effects on organs: no macroscopic findings were noted at necropsy.
- Other findings:
- Signs of toxicity (local):
COLORATION:
blue test item remnants were noted in all animals after
removal of the dressing and persisted in five animals up to
day 13.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 > 2000 mg/kg
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