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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

Reference
Name:
Unnamed
Type:
Constituent
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