Registration Dossier
Registration Dossier
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EC number: 929-125-7 | CAS number: 1160293-25-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 February - 23 February 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 423) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- yes
Test material
- Reference substance name:
- PD 282 XX
- IUPAC Name:
- PD 282 XX
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): PD 282 XX
- Molecular weight (if other than submission substance): 267.67
- Physical state: rust-coloured crystals
- Analytical purity: 99.6 % (HPLC)
- Purity test date: 12 january 2006
- Lot/batch No.: V12SRE00325
- Expiration date of the lot/batch: stability confirmed until november 2006
- Storage condition of test material: at room temperature, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI (Han)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % aqueous hydroxyethylcellulose
- Doses:
- 200, 2000 mg/kg
- No. of animals per sex per dose:
- 3 males and 6 female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: ALD (approximate lethal dose)
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no animals died at any time of the study
- Clinical signs:
- other: Piloerection was observed at both doses as the only clinical sign on day 1
- Gross pathology:
- No necropsy findings were noted in females treated with 200 mg/kg or 2000 mg/kg. Following 2000 mg/kg no alterations were observed in two male rats and one male rat revealed multiple disseminated, pin-sized, dark red discolourations of the lungs.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute oral toxicity test, an approximate lethal dose of the test substance in rats was determined to be > 2000 mg/kg.
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