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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
2020
Report date:
2020

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
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
Chemical structure
Reference substance name:
L-Tyrosine, N-acetyl-3,5-dinitro-, etyhl ester
Cas Number:
29358-99-4
Molecular formula:
C13H15N3O8
IUPAC Name:
L-Tyrosine, N-acetyl-3,5-dinitro-, etyhl ester

In vitro test system

Test system:
human skin model
Source species:
human

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3
Value:
109.9
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
108.5
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
2
Value:
109
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item L-Tyrosine, N-acetyl-3,5-dinitro-, ethyl ester is considered as non-irritant to skin.After the treatment, the mean value of relative tissue viability was increased to 109.1%. 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 con-trol and test item (required: ≤ 18%).

For these reasons, the result of the test is considered valid.
Executive summary:

Three tissues of the human skin model EpiDermTM were treated with the test item for 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 mean absorbance value was within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.4.


The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 3.3% (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 109.1%. This value is above the threshold for skin irritation potential (50%). Test items that induce values above the threshold of 50% are considered non-irritant to skin.


 


 


Therefore, the test item L-Tyrosine, N-acetyl-3,5-dinitro-, ethyl ester is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.