Registration Dossier
Registration Dossier
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EC number: 849-913-3 | CAS number: 93216-90-1
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- 1-(4-methoxyphenyl)-2-methyl -2-morpholinopropan-1-one
- EC Number:
- 849-913-3
- Cas Number:
- 93216-90-1
- Molecular formula:
- C15H21NO3
- IUPAC Name:
- 1-(4-methoxyphenyl)-2-methyl -2-morpholinopropan-1-one
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- olive oil
- Doses:
- The starting dose can be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item was likely to be non-toxic regarding acute toxicity therefore we chose a dose of 2000 mg of 1-(4-methoxyphenyl)-2-methyl-2-(morpholin-4-yl)propan-1-one per kg body weight to be used as a starting dose. In the first step, one group of 3 females was dosed. The test item in limit dose did not cause mortality for 48 hours and therefore, in a second step, another 3 females were treated at the same dose level.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Clinical signs:
- No signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period at limit dose of 2000 mg/kg body weight was observed in Animals No 1–4 and No 6. Mortality at limit dose of 2000 mg/kg body weight was observer in Animal No 5 within first 24 h with only mild signs of adverse effect (piloerection).
- Body weight:
- The body weights of all animals increased during the study
- Gross pathology:
- All animals were necropsied. No visible pathological findings were observed in animals dosed with 2000 mg/kg body weight.
Applicant's summary and conclusion
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