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EC number: 911-553-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.-15.-09.17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- 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)
- Version / remarks:
- 2015
- Deviations:
- yes
- Remarks:
- ,The pre-incubation time was 1 hour, instead of 18- 24 hours. This can be seen as uncriti-cal, because the pre- incubation time must be at least 1 hour (in consultation with the tissue supplier; MatTek In Vitro Life Science Laboratories).
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of N-(hydroxymethyl)hexadecan-1-amide and N-(hydroxymethyl)stearamide
- EC Number:
- 911-553-0
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction mass of N-(hydroxymethyl)hexadecan-1-amide and N-(hydroxymethyl)stearamide
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Commercially available EpiDermTM-Kit.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes, which have been cul-tured 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.
Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SIT
Day of delivery: 13. Sep. 2017
Batch no.: 25841 - Control samples:
- yes, concurrent negative control
- yes, concurrent no treatment
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
#1 25.3 mg, #2 25.0 mg, #3 25.3 mg
- Concentration (if solution):
-
VEHICLE
- Amount(s) applied (volume or weight with unit):
-
- Concentration (if solution):-
- Lot/batch no. (if required):-
- Purity:-
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
30 µL DPBS buffer per tissue
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight):
30 µL SDS buffer per tissue
- Concentration (if solution): - Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 22 h
- Number of replicates:
- 3 tissues
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- #01
- Value:
- 104.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- #02
- Value:
- 104
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- #03
- Value:
- 103.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The mean value of relative tissue viability of the test item was increased to 104.1 % after the treatment. This value is above the threshold for skin irritation (50 %). Therefore, the test item is considered as non-irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item N-(hydroxymethyl) stearamide is considered as non-irritant to skin.
- Executive summary:
One valid experiment was performed.
Three tissues of the human skin model EpiDermTMwere treated withN-(hydroxymethyl) stearamidefor 60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by the supplier).
DPBS-buffer was used as negative control and 5 % SDS solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 2.0. The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 2.5 % (required:£20 %).
The variation within the tissue replicates of negative, control, positive control and test item was acceptable (required: ≤ 18 %).
After the treatment with the test item, the mean value of relative tissue viability was increased to 104.1 %. This value is above the threshold for skin irritation potential (50 %). Values above the threshold of 50 % are considered non-irritant to skin.
Therefore,N-(hydroxymethyl) stearamideis considered non-irritant to skin in the Reconstructed Human Epidermis (RhE) Test Method.
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