reaction mass of 3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one and 1-(2,6,6-trimethylcyclohex-2-en-1-yl)pent-1-en-3-one

Specific investigations: other studies

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Reference 2

Reference Type:

publication

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 3

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

Test material information

1

Reference substance name:

(1E)-1-(2,6,6-trimethylcyclohex-2-en-1-yl)pent-1-en-3-one; (3E)-3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one

EC Number:

942-741-0

Cas Number:

1335-46-2

Molecular formula:

C14H22O

IUPAC Name:

(1E)-1-(2,6,6-trimethylcyclohex-2-en-1-yl)pent-1-en-3-one; (3E)-3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one

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.