1-(9,9-Dibutyl-9H-fluoren-2-yl)-2-methyl-2-morpholin-4-yl-propan-1-one

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:

2017

Report date:

2017

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:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(9,9-dibutyl-9H-fluoren-2-yl)-2-methyl-2-(morpholin-4-yl)propan-1-one

EC Number:

819-558-9

Cas Number:

2020359-04-8

Molecular formula:

C29H39NO2

IUPAC Name:

1-(9,9-dibutyl-9H-fluoren-2-yl)-2-methyl-2-(morpholin-4-yl)propan-1-one

Test material form:

solid: particulate/powder

Details on test material:

a off-white powdery solid, without irritating odor

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Age at First Dose 8-12 weeks; female animals were non-pregnant and nulliparous
Animal Health Health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning. The average room temperature was maintained within the range of 23.36±0.2° C, relative humidity within 54.61± 1.9 %.The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following the period of fasting, the animals were weighted and the test item was administered. After test item administration, food was withheld for further 3-4 hours.

Doses:

5, 50, 300, and 2000 mg/kg body weigh

No. of animals per sex per dose:

One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.

Clinical signs:

other: No mortality was observed during the study. During the follow up period, no animals displayedsigns of intoxication, change of health,nor any other adverse reaction.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item 1-(9,9-Dibutyl-9H-fluoren-2-yl)-2-methyl-2-morpholin-4-yl-propan-1-oneisgreater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item 1-(9,9-Dibutyl-9H-fluoren-2-yl)-2-methyl-2-morpholin-4-yl-propan-1-oneis classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.