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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

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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:
1946
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:
1975
Bibliographic source:
Food & Cosmetics Toxicology, 13:549, p444
Reference Type:
secondary source
Title:
Fragrance material review on ionone
Author:
Lalko J et al.
Year:
2007
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:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S130–S167

Materials and methods

Test material

Constituent 1
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

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