Registration Dossier

Diss Factsheets

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:
2020

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

Constituent 1
Chemical structure
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

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

Categories Display