Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
EC Number:
404-360-3
EC Name:
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
Cas Number:
119313-12-1
Molecular formula:
C23 H30 N2 O2
IUPAC Name:
2-benzyl-2-(dimethylamino)-1-[4-(morpholin-4-yl)phenyl]butan-1-one

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80 in distilled water
Doses:
2000 mg/kg bw
5000 mg/kg bw
No. of animals per sex per dose:
5

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: Unspecific symptoms of intoxication, reversible within 10 days in all of the animals.
Gross pathology:
Effects on organs: No findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU