Registration Dossier
Registration Dossier
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EC number: 201-224-3 | CAS number: 79-77-6
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Acceptable publication which meets basic scientific principles. Due to structural similarities of the registered substance trans-ß-ionone (CAS 79-77-6) and the used test substance (mixture of α- and β-isomers, CAS 8013-90-9) the data could be taken into account for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Dermal irritating properties of essential oils and aromatic chemicals
- Author:
- Katz AE
- Year:
- 1 946
- Bibliographic source:
- cited in the RIFM/FEMA database, location 5414; The Spice Mill, 69, 46-47, 50-51
- Reference Type:
- secondary source
- Title:
- Monographs on fragrance raw materials: ionone
- Author:
- Opdyke DLJ
- Year:
- 1 975
- Bibliographic source:
- Food & Cosmetics Toxicology, 13:549, p444
- Reference Type:
- secondary source
- Title:
- Fragrance material review on ionone
- Author:
- Lalko J et al.
- Year:
- 2 007
- Bibliographic source:
- Food and Chemical Toxicology 45 (2007) S251–S257
- Reference Type:
- secondary source
- Title:
- A toxicologic and dermatologic assessment of ionones when used as fragrance ingredients
- Author:
- Belsito D et al.
- Year:
- 2 007
- Bibliographic source:
- Food and Chemical Toxicology 45 (2007) S130–S167
Materials and methods
Test material
- Reference substance name:
- Ionone
- EC Number:
- 232-396-8
- EC Name:
- Ionone
- Cas Number:
- 8013-90-9
- IUPAC Name:
- 4-(2,6,6-trimethylcyclohex-1-en-1-yl)but-3-en-2-one
- Details on test material:
- - Name of test material (as cited in study report): ionone standard
Constituent 1
Method
- Details on study design:
- - A 24 hour closed patch test was conducted on 11 male and female volunteers.
- Test material was applied undiluted to an area on the inner arm of the subjects measuring 1 cm in diameter.
- Crystalline substances were applied in the same manner except as saturated alcoholic solutions.
- Immediately following application, the area was covered with an adhesive bandage for 24 hours.
- Reactions were read daily for 5 days.
- Applications which produced visible inflammation, irritation, formation of a popular rash, or any abnormal condition of the area, were considered positive reactions.
- All positive reactions were confirmed by repetition of the test on the same subject after complete disappearance of positive systems.
- Results listed are number of positive reactions observed in the number of tests conducted
Results and discussion
- Results:
- no effects observed
Applicant's summary and conclusion
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