Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 815-708-2 | CAS number: 83249-56-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- 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:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- L-Tyrosine, N-acetyl-3,5-diiodo-O-(4-methoxyphenyl)-, ethyl ester
- Cas Number:
- 83249-56-3
- Molecular formula:
- C20H21I2NO5
- IUPAC Name:
- L-Tyrosine, N-acetyl-3,5-diiodo-O-(4-methoxyphenyl)-, ethyl ester
- Test material form:
- solid
Constituent 1
In vitro test system
- Details on the study design:
- The study was performed in order to evaluate the reactivity of the test item L-Tyrosine, N-acetyl-3,5-diiodo-O-(4-methoxyphenyl)-, ethyl ester towards cysteine (Cys-) and lysine (Lys-) containing peptides. A test item solution in acetonitrile and the respective peptide was incubated 22 h and 5 min for the Cys-peptide and 22 h for the Lys-peptide at 25 °C, respectively, and the peptide concentration after the incubation was measured using HPLC-UV.
Three replicates were prepared using 1:10 and 1:50 molar ratio of the test item with the Cys- and Lys-peptide, respectively. Triplicate samples of the solvent without test item were incubated and measured simultaneously.
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Experiment 2
- Parameter:
- other: % Cys-peptide depletion
- Value:
- 36.09
- Key result
- Run / experiment:
- other: Experiment 1
- Parameter:
- other: % Lys-peptide depletion
- Value:
- 0.41
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, the DPRA prediction is “positive” with low reactivity according to the Cysteine 1:10/Lysine 1:50 prediction model. It can be stated that in this study and under the experimental conditions reported, the test item L-Tyrosine, N-acetyl-3,5-diiodo-O-(4-methoxyphenyl)-, ethyl ester possesses low skin sensitization potential.
- Executive summary:
All acceptance criteria were fulfilled. Therefore, the test was considered valid. The DPRA prediction for the test itemL-Tyrosine, N-acetyl-3,5-diiodo-O-(4-methoxyphenyl)-, ethyl esterwas positive with reactivity class low according to the Cysteine 1:10/Lysine 1:50 prediction model.
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made.
The mean peptide depletion in the Cys-peptide and Lys-peptide assay was 18.25 %, therefore the test item was classified with:
DPRA Prediction: Positive
Reactivity class: Low
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
