Registration Dossier
Registration Dossier
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EC number: 616-968-8 | CAS number: 8015-92-7
Endpoint summary
Administrative data
Description of key information
No in vitro skin sensitisation studies or in vivo murine LLNA were identified, or are required, as a reliable in vivo guinea pig study is already available.
The skin sensitisation potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in guinea pigs in an in vivo open epicutaneous test. 0.1 mL of the test material (as a 4% solution) was applied to clipped skin on one flank of each of 6 guinea pigs, daily for 21 days. A challenge application was made on the contralateral flank on days 21 and 25. Anthemis nobilis, ext., (Chamomile oil) was not sensitising to the skin of guinea pigs in this study (Klecak, 1985).
No respiratory tract sensitisation data are available.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Open Epicutaneous Test: the test material was applied to 6 guinea pigs (males and females) on an 8 cm2 area of clipped flank skin, daily for 3 weeks. The test site remained uncovered. Reactions were scored at the end of the application period or the end of each week. The challenge was applied in the same way on the contralateral flank, on days 21 and 25 of the study. 10 guinea pigs served as controls.
- GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- Adequate and well-described in vivo study available in published literature.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- 0.1 mL, 4% solution
- Day(s)/duration:
- 21 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Remarks:
- Contralateral flank used for challenge phase.
- Concentration / amount:
- 0.1 mL, 4%
- Day(s)/duration:
- Day 21, 24 hours
- Adequacy of challenge:
- other: minimal irritating concentration
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Remarks:
- Contralateral flank used for challenge phase
- Concentration / amount:
- 0.1 mL, 4%
- Day(s)/duration:
- Day 25, 24 hours
- Adequacy of challenge:
- other: minimal irritating concentration
- No. of animals per dose:
- 6
- Details on study design:
- RANGE FINDING TESTS: Pretesting phase established primary irritating threshold concentration. [No further details]
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Exposure period: 21 days
- Test groups: 6 animals/group
- Control group: 10 animals
- Site: flank
- Frequency of applications: daily
- Duration: 24 hours
- Concentrations: Not specified (maximum tested concentration 4%)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21 and 35
- Exposure period: 24 hours
- Test groups: 6 animals/group
- Control group: 10 animals
- Site: flank, contralateral to induction site
- Concentrations: Not specified (maximum tested concentration 4%)
- Evaluation (hr after challenge): 24, 48 and/or 72 hours - Challenge controls:
- 10 negative controls, not subjected to treatment during induction phase.
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 4%
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 4%
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 4%
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the open epicutaneous test, Anthemis nobilis, ext. (Chamomile oil) was found to be non-sensitising to the skin of guinea pigs.
- Executive summary:
The skin sensitisation potential of Anthemis nobilis, ext., (Chamomile oil) was assessed in guinea pigs in an open epicutaneous test. 0.1 mL of the test material (as a 4% solution) was applied to clipped skin on one flank of each of 6 guinea pigs, daily for 21 days. A challenge application was made on the contralateral flank on days 21 and 25. Anthemis nobilis, ext., (Chamomile oil) was not sensitising to the skin of guinea pigs in this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A CIR expert review (Johnson et al, 2017) summarised the results of several studies assessing the human skin sensitisation potential of Anthemis nobilis, ext. In a maximization test involving 25 subjects, a 4% solution (in petrolatum) of Anthemis nobilis “flower oil” was not a skin sensitiser. In repeated insult patch tests in humans (HRIPTs), Anthemis nobilis essential oil [concentration unspecified] did not induce skin sensitisation in 104 and 110 patients. A skin care lotion containing 3% Anthemis nobilis “flower oil” was also tested in a HRIPT and found not to have a potential for eliciting dermal sensitisation. Results were negative in 29 patients patch tested with Anthemis nobilis, ext. (1% in petrolatum), while in a provocative patch test, 2 of 14 patients displayed reactions to Anthemis nobilis (again at 1% in petrolatum) that were described as “++”. Allergic dermatitis and other sensitisation reactions to Anthemis nobilis ingredients have been reported in a small number of individual case reports.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No respiratory tract sensitisation data are available. A new study was not conducted as no standard and validated test method is available and it is not a REACH Standard Information Requirement.
Justification for classification or non-classification
Based on the results of the available and reliable in vivo guinea pig study (Klecak, 1985), Anthemis nobilis, ext., (Chamomile oil) does not warrant classification for skin sensitisation, according to EU CLP criteria (EC 1272/2008).
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