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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

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

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: not specified

Source strain:

not specified

Details on animal used as source of test system:

6.4.1Specification
The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
6.4.2Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SIT
Day of delivery: 13. Sep. 2018
Batch no.: 25841

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

26.1 mg/mL

Duration of treatment / exposure:

3 hours

Duration of post-treatment incubation (if applicable):

shaken (120 rpm) for 2 hours

Number of replicates:

24-well-plate

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

98.7

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The test item 1-(9,9-Dibutyl-9H-fluoren-2-yl)-2-methyl-2-morpholin-4-yl-propan-1-one is considered as non-irritant to skin.
After the treatment, the mean value of relative tissue viability was reduced to 98.7%. This value is abovethe threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.
Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).
For these reasons, the result of the test is considered valid.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

After the treatment with the test item, the mean value of relative tissue viability was reduced to 98.7 %. This value is above the threshold for skin irritation potential (50%). Values above the threshold of 50% are considered non-irritant to skin.
Therefore, 1-(9,9-Dibutyl-9H-fluoren-2-yl)-2-methyl-2-morpholin-4-yl-propan-1-one is considered non-irritant to skin in the Reconstructed Human Epidermis (RhE) Test Method.