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Skin sensitisation

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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

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)

Inductionopen allclose all
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
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)

Resultsopen allclose all
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
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.

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