Registration Dossier
Registration Dossier
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EC number: 616-968-8 | CAS number: 8015-92-7
Skin sensitisation
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:
- 1 985
- 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:
- 2 017
- 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 substance name:
- 2-methylpentyl 2-methylisocrotonate
- EC Number:
- 280-815-8
- EC Name:
- 2-methylpentyl 2-methylisocrotonate
- Cas Number:
- 83783-81-7
- Molecular formula:
- C11H20O2
- IUPAC Name:
- 2-methylpentyl 2-methylbut-2-enoate
- Reference substance name:
- 2-methylallyl 2-methylisocrotonate
- EC Number:
- 262-901-7
- EC Name:
- 2-methylallyl 2-methylisocrotonate
- Cas Number:
- 61692-78-2
- Molecular formula:
- C9H14O2
- IUPAC Name:
- 2-methylprop-2-en-1-yl 2-methylbut-2-enoate
- Reference substance name:
- Isobutyl isobutyrate
- EC Number:
- 202-612-5
- EC Name:
- Isobutyl isobutyrate
- Cas Number:
- 97-85-8
- Molecular formula:
- C8H16O2
- IUPAC Name:
- isobutyl 2-methylpropanoate
- Reference substance name:
- 6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
- EC Number:
- 227-705-8
- EC Name:
- 6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
- Cas Number:
- 5947-36-4
- Molecular formula:
- C10H16O
- IUPAC Name:
- 6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
- Reference substance name:
- Pin-2(3)-ene
- EC Number:
- 201-291-9
- EC Name:
- Pin-2(3)-ene
- Cas Number:
- 80-56-8
- Molecular formula:
- C10H16
- IUPAC Name:
- 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
- Test material form:
- liquid
- Details on test material:
- None given
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
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 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
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.
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