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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to 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:
Cas Number:
Molecular formula:
It cannot be provided.
Fatty acids, palm-oil (C16-C18), Me esters, chlorinated (35-45 % w/w)
Test material form:
Details on test material:
Batch number: SV210723R 4001

In vitro test system

Test system:
human skin model
Source species:
Cell type:
non-transformed keratinocytes
Cell source:
other: Reconstructed Human Epidermis (RHE), 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK).
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:

Results and discussion

In vitro

Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 Vitality tests
ca. 96.7
Vehicle controls validity:
Positive controls validity:
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
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.