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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.