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EC number: 815-855-2 | CAS number: 440667-78-7
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:
- 2 020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- ethyl (2S)-3-[3,5-diamino-4-(4-methoxyphenoxy)phenyl]-2-acetamidopropanoate
- Cas Number:
- 440667-78-7
- Molecular formula:
- C20H25N3O5
- IUPAC Name:
- ethyl (2S)-3-[3,5-diamino-4-(4-methoxyphenoxy)phenyl]-2-acetamidopropanoate
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other:
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 109.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 122.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 111.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
For the test item and the positive control, the following percentage values of tissue viability
were calculated in comparison to the negative control:
Table 9.2-a % Tissue Viability
Designation
L-Tyrosine, N-acetyl3,5-diamino-O-(4-
methoxyphenyl)-,
ethyl ester
Positive Control
% Tissue viability (tissue 1) 111.3% 3.3%
% Tissue viability (tissue 2) 122.4% 3.4%
% Tissue viability (tissue 3) 109.8% 3.3%
% Tissue viability (mean) 114.5% 3.3%
± SD of mean tissue viability (%) 6.9% 0.1%
9.3 Assessment and Validity
9.3.1 Skin Irritation Potential of the Test Item
The mean value of relative tissue viability of the test item was increased to 114.5% after the
treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item
is considered as non-irritant to skin.
9.3.2 Validity and Acceptability
Validity criteria and results are stated in the following table:
Table 9.3-a Validity
Criterion Demanded Found
OD of negative control ≥ 0.8 and ≤ 2.8 1.4
% tissue viability
of positive control SDS 20% of negative control 3.3%
SD of mean viability of the
tissue replicates (%) ≤ 18%
3.0% (negative control)
0.1% (positive control)
6.9% (test item)
All validity criteria were met.
The values for negative control and for positive control were within the range of historical
data of the test facility (see annex 2, page 20).
Therefore, the experiment is considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester is considered as non-irritant to skin.
After the treatment, the mean value of relative tissue viability was increased to 114.5%. This
value is above the 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. - Executive summary:
Therefore, the test item L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl
ester is considered non-irritant to skin in the Reconstructed human Epidermis (RhE)
Test Method.
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