Registration Dossier
Registration Dossier
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EC number: 289-997-3 | CAS number: 90063-39-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Ledum palustre, Ericaceae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 February to10 March 2016.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- temperature in incubator reached 38.4°C which is +0.4°C higher than 37±1°C as initially scheduled in study plan. Considering the results obtained in tissues treated with the test item, deviation considered as without impact on the conclusion of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ledum palustre, extract
- EC Number:
- 289-997-3
- Cas Number:
- 90063-39-1
- Molecular formula:
- UVCB substance, not relevant.
- IUPAC Name:
- Ledum palustre, extract
- Test material form:
- liquid
- Details on test material:
- UVCB substance : see composition at section 1
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell source:
- other: reconstructed epidermis Episkin
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- versus 0.7% in the positive control
- Value:
- 84.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
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 Teinture mère de Ledum palustre – code L12C has to be considered as Non-irritant to skin in accordance with UN GHS No Category.
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