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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication/ study report which meets basic scientific principles

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Screening of fragrance materials for allergenicity in the guinea pig. I. Comparison of four testing methods

Author:

Klecak G et al.

Year:

1977

Bibliographic source:

Journal of the Society of Cosmetic Chemists Japan, 28, 53-64, 1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

GPMT

Principles of method if other than guideline:

Guinea pig maximization test according to:
B. Magnusson and A.M. Kligman, The identification of contact allergend by animal assay. The guinea pig miximization-test, ibid., 52, 268-7 (1969).
B. Magnusson and A.M. Kligman, Alelrgic contact dermatitis in the guinea pig, Charles C. Thomas, Springfield, Illinois, 197.

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Available study

Test material

Test material information

Constituent 1

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

Specific details on test material used for the study:

none provided in the publication

In vivo test system

Test animals

Species:

guinea pig

Strain:

Himalayan

Remarks:

white-spotted

Sex:

male/female

Details on test animals and environmental conditions:

weight: 400 - 500 g

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

petrolatum

Concentration / amount:

2 injections of 5%
2 injections of 5% in FCA
2 injections of FCA alone

Day(s)/duration:

Once on Day 0

Adequacy of induction:

not specified

Induction 2

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

25% solution in petrolatum of 250mg compound

Day(s)/duration:

Once on day 8 for 48hrs under occlusion

Adequacy of induction:

other: concentration which always causes mild to moderate skin irritation under occlusion

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

specified as sub-irritant

Day(s)/duration:

Once on day 21 for 24hrs

No. of animals per dose:

no data

Details on study design:

Intradermal inductions consisted of 2 injections of 0.1 ml of 5 % test material; 2 injections of 0.1 ml of a 5 % emulsion of test material in Freund's complete adjuvant (FCA); 2 injections of FCA alone on day 0. In addition, 250 mg test material dissolved in petrolatum at 25 % concentration was applied on day 8 under occlusion for 48 hours to a clipped area of the neck.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 injections at day 0
- Site: intreadermal
- Concentrations: 5 % in 0.1 ml; with and without Freund's Complete Adjuvant (FCA)
- Control: FCA alone
- in additon: after 8 days 250 mg test material dissolved in petrolatum at 25 % concentration was applied on day 8 under occlusion for 48 hours to a clipped area of the neck.


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) after study begin: 21
- Exposure period: 24 h
- Site: flank
- Concentrations: subirritant concentration in petrolatum via closed patch
- Evaluation (hr after challenge): 24, 48 h after patch removal

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

subirritant concentration

No. with + reactions:

0

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

subirritant concentration

No. with + reactions:

0

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

no effects observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Methyl Ionone did not show any skin sensitizng potential under this Guina Pig Maximisation test when tested intradermally at 5% and topically at 25%.

Executive summary:

The guinea pig maximization test was conducted using outbred Himalayan white-spotted male and female guinea pigs (400-500 grams). Intradermal inductions consisted of 2 injections of 0.1 ml of 5% test material; 2 injections of 0.1 ml of a 5% emulsion of test material in Freund's complete adjuvant (FCA); 2 injections of FCA alone on day 0. In addition, 250 mg test material dissolved in petrolatum at 25% concentration was applied on day 8 under occlusion for 48 hours to a clipped area of the neck. Challenge on day 21 was via a 24 hour closed patch applied to the flank at subirritant concentration. Reactions were read at 24 and 48 hours after removing the patch.No reactions were observed.