Registration Dossier

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
Reference
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.

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).