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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

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
Reference Type:
secondary source
Title:
No information
Author:
Klecak G et al.
Year:
2003
Bibliographic source:
RIFM Database
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

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Guinea pig maximization test
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA method was not available yet by the time the study was conducted. Moreover, an appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.

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-

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
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:
secified as subirritant
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
secified as subirritant
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
subirritant concentration
No. with + reactions:
0
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: subirritant concentration. No with. + reactions: 0.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
subirritant concentration
No. with + reactions:
0
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: subirritant concentration. No with. + reactions: 0.0.

Any other information on results incl. tables

no effects observed

Applicant's summary and conclusion