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Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The Freund’s Complete Adjuvant Test and the Open Epicutaneous Test.
Author:
Klecak, G.,
Year:
1985
Bibliographic source:
Current Problems in Dermatology, Vol. 14, 152-171.
Reference Type:
review article or handbook
Title:
Safety Assessment of Anthemis nobilis– Derived Ingredients as Used in Cosmetics
Author:
Johnson W, Heldreth B, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW and Andersen FA
Year:
2017
Bibliographic source:
International Journal of Toxicology 36(Supp. 1), 57S-66S.

Materials and methods

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.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
None given

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
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
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
4%
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
4%
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
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

Applicant's summary and conclusion

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.