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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study carried out between the 10 February and the 01 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 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
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
- Specific details on test material used for the study:
- Teinture mère de Calendula officinalis – code C19F. Batch No.: M4080014
In vivo test system
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Groups of four mice were treated with the test item at 100% and diluted at 50% and 25% in the vehicle Dimethyl formamide (DMF).
- No. of animals per dose:
- four mice per dose
- Details on study design:
- The mice were treated by daily application of 25 µL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
- Positive control substance(s):
- other: vehicle
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- ca. 0.75
- Variability:
- The Stimulation Index (SI) calculated by individual approach was 0.83, 0.80 and 0.75 for the treated groups at 25%, 50% and 100%, respectively.
- Test group / Remarks:
- The EC1.6 cannot be determined in this study.
- Remarks on result:
- other:
- Remarks:
- No Stimulation index of more than 1.6 was recorded with the three tested concentrations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained, in these experimental conditions, enable to conclude that the test item Tincture mother of Calendula officinalis (Teinture mère de Calendula officinalis) – code C19F does not have to be classified in category 1, in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
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