Registration Dossier
Registration Dossier
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EC number: 204-370-6 | CAS number: 120-11-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: 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:
- 2 018
Materials and methods
Test guideline
- 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
- Reference substance name:
- Benzyl 2-methoxy-4-prop-1-enylphenyl ether
- EC Number:
- 204-370-6
- EC Name:
- Benzyl 2-methoxy-4-prop-1-enylphenyl ether
- Cas Number:
- 120-11-6
- Molecular formula:
- C17H18O2
- IUPAC Name:
- benzyl 2-methoxy-4-prop-1-enylphenyl ether
Constituent 1
In vitro test system
- Test system:
- human skin model
- Amount/concentration applied:
- 16 mg if the test item
- Duration of treatment / exposure:
- during 15 minutes for the EPISKIN SM or during 42 minutes for the SkinEthic RHE model
- Duration of post-treatment incubation (if applicable):
- viability measurements are performed after a 42 hours post-treatment incubation period
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- SPL 19
- Value:
- 109.9
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- SPL 20
- Value:
- 126.3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- SPL 21
- Value:
- 116.1
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the Regulation EC No. 1272/2008, the test item BENZYL ISO EUGENOL has
to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required. - Executive summary:
The aim was to evaluate the possible irritating effects of the test item BENZYL ISO EUGENOL after topical application on in vitro human reconstructed epidermis (SkinEthic RHE® model).
The test item BENZYL ISO EUGENOL was applied as supplied, at the dose of 16 mg to 3 living Reconstructed Human epidermis (SkinEthic RHE® model) during 42 minutes. The application was followed by a rinse with 25 mL of DPBS and a 42 hours post-incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.
The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 439 adopted 28 July 2015 and the Test method B.46 of Council regulation No. 761/2009 dated
23 July 2009 (EU Journal L220) - ATP Council regulation No. 440/2008 of 30 May 2008 (E.U. Journal L142).
The mean percent viability of the treated tissues was 117.4% (considered as 100%), versus 1.7 % in the positive control (5% Sodium Dodecyl Sulfate).
In accordance with the Regulation EC No. 1272/2008, the test item BENZYL ISO EUGENOL has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.
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