Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
phototoxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication/ study report which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982
Reference Type:
secondary source
Title:
Fragrance material review on methyl ionone (mixture of isomers)
Author:
Lalko J et al.
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S300–S307
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

Type of method:
in vivo
Endpoint addressed:
skin irritation / corrosion

Test material

Constituent 1
Chemical structure
Reference substance name:
Ionone, methyl-
EC Number:
215-635-0
EC Name:
Ionone, methyl-
Cas Number:
1335-46-2
Molecular formula:
C14H22O
IUPAC Name:
Ionone, methyl-
Details on test material:
- Sample No: S.12693T3

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Housing: individually
- Age at study initiation: 24 - 27 days
- Site: clipped on dorsum

Administration / exposure

Route of administration:
dermal
Vehicle:
ethanol
Details on exposure:
Three groups of 10 individually housed Wistar rats (aged 24 - 27 days) were clipped on the dorsum.
One group (Group A) was topically treated with 0.1 ml of 30 % test substance in ethanol. After 20 minutes, the rats were irradiated for 2 hours 30 minutes at 300-400 nm (12 Jcm(-2) UV) using fluorescent blacklamps (Philips TL40W/08). The intensity at a skin distance of 33 cm was 1.34x10(-3) Wcm(-2).
A second group (Group B) also was treated with 0.1 ml of 30% test substance in ethanol, but was not irradiated.
The third group (Group C) was first irradiated under the same conditions as Group A and then treated with the test material as both Group A and B.
Doses / concentrations
Remarks:
Doses / Concentrations:
0.1 ml of 30 % test substance in ethanol
Basis:

No. of animals per sex per dose:
10 animals/group ot of 15 male and 15 female
Control animals:
other: treated identically, not irradiated... (see attached file)

Examinations

Examinations:
Skin reactions were assessed under standard lighting conditions for erythema, edema, cracking, scaling, dryness, hemorrhage, ulceration, scabbing and exudation at 3, 6, 24, 48, and 72 hours using a standard 9-point scoring system ranging from “0” (absent) to “9” (missing value).
Positive control:
The results were also compared to 10 and 30 % oil of Bergamot.

Results and discussion

Details on results:
30 %: phototoxic effects
phototoxic effects were observed in animals treated with methyl ionone followed by irradiation

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the authors concluded that the phototoxic activity of 30% test substance was certainly weaker than 30% oil of Bergamot and was probably weaker than 10% oil of Bergamot.