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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, data only from secondary source. Due to structural similarities of the registered substance trans-ß-ionone (CAS 79-77-6) and the used test substance ß-ionone (CAS 14901-07-6) the study data could be taken into account for assessment.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Toxicology studies of beta-ionone in the guinea pig
Author:
Takasago International Corporation
Year:
1999
Bibliographic source:
cited in RIFM/FEMA database, location 35056
Report Date:
1999
Reference Type:
secondary source
Title:
Fragrance material review on beta-ionone
Author:
Lalko J et al.
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S241–S247
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:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
Freund's complete adjuvant test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hartley strain albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC, Inc.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Freund's Complete Adjuvant
Concentration / amount:
5, 10, 20, 40, 50%
Challengeopen allclose all
Route:
other: epicutanous, unspecified
Vehicle:
other: Freund's Complete Adjuvant
Concentration / amount:
5, 10, 20, 40, 50%
No. of animals per dose:
together 5 animals for test and 4 animals for control
Details on study design:
- Hair on the back of the animals was cut with an electric clipper and an electric shaver
- Four hours after depilation, based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected.
- For the purpose of this study the test material was freshly prepared as follows:
[Intradermal Induction]: 10% w/v in Complete Adjuvant, 10% w/v in a mixture of Freund's Complete Adjuvant plus physiological saline (1:1);
[Topical Induction]: 10% w/v in Complete Adjuvant;
[Topical Challenge]: 50, 40, 20, 10, 5% w/v in acetone.
- The concentration, homogeneity and stability of the test material formulations were not determined.

SCORING
- The intensity of skin reaction was graded from 0 to 8 scale.
- The criteria and scoring system for assessment of dermal reaction are those of Draize J.H. (1959).
- The scores for erythema and edema at 48-hour reading were totaled for the five test guinea pigs (5 values) and this total was divided by 5 to give the sensitisation index of the test material

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
5, 10, 20, 40, 50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5, 10, 20, 40, 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion