Registration Dossier

Diss Factsheets

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:
2022
Report date:
2022

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

Constituent 1
Reference substance name:
Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)
EC Number:
953-553-3
Cas Number:
95009-45-3
Molecular formula:
It cannot be provided.
IUPAC Name:
Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)
Test material form:
liquid
Details on test material:
Batch number: SV210723R 4001

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: Reconstructed Human Epidermis (RHE), 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK).
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
About 50 mg of the test substance are weighed on a glass weighing boat. Then the sample is evenly poured on the tissue. The exact weight of the sample is not a critical factor, but it is necessary to cover all the surface of the tissue homogeneously.
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
After 24±2 hours of incubation, the tissues were transferred to new plates containing 0.9 mL of fresh medium in each well and incubated for an additional 18±2 hours (37 °C, 5% CO2).
Number of replicates:
3

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 Vitality tests
Value:
ca. 96.7
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The average OD for negative control (C-) was f 1.257. This value corresponds to 100% vitality of the tissues.
The vitality of tissues trated with positive control was 3.5%.
The vitality of tissues trated with test item was 96.7% with SD 3.8%.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is considered not irritant for human skin.
Executive summary:

The test substance was tested through a validated in vitro skin irritation study in accordance with  bottom-up approach. Under the test conditions, the test substance was not irritant for Reconstructed Human Epidermis (RHE) as % tissue viability was about 96.7. Overall, the test substance is not considered as a skin irritant.