Registration Dossier
Registration Dossier
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EC number: 283-949-5 | CAS number: 84776-23-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Calendula officinalis, Compositae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study carried out from 03 February to 03 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:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Calendula officinalis, ext.
- EC Number:
- 283-949-5
- EC Name:
- Calendula officinalis, ext.
- Cas Number:
- 84776-23-8
- Molecular formula:
- UVCB substance, not relevant.
- IUPAC Name:
- Calendula officinalis, ext.
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Skin Ethic RHE model
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent positive control
- Amount/concentration applied:
- dose of 16 µL
- Duration of treatment / exposure:
- to 3 Reconstructed Human epidermis during 42 minutes, followed by a rinse with 25 mL of PBS and a 42 hours and 08 minutes post-incubation period at 37°C, 5% CO2 .
Test system
- Vehicle:
- unchanged (no vehicle)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 92.7
- Positive controls validity:
- valid
- Remarks:
- 0.7% in the positive control (5% Sodium Dodecyl Sulfate)
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 Tincture mother of Calendula Officinalis (Teinture mère de Calendula officinalis) – code C19F has to be considered as non-irritant to skin in accordance with UN GHS No Category.
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.
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