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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Reference
Reference Type:
review article or handbook
Title:
Sensitization to 26 fragrances to be labelled according to current European regulation - Results of the IVDK and review of the literature
Author:
Schnuch et al.
Year:
2007
Bibliographic source:
Contact Dermatitis 2007: 57: 1–10

Materials and methods

Type of sensitisation studied:
skin
Study type:
survey
Test guideline
Qualifier:
according to
Guideline:
other: recommendations of the International Contact Dermatitis Research Group (12) and the German Contact Dermatitis Research Group (DKG)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
other: occupational and general
Subjects:
- Number of subjects exposed: 2003
Clinical history:
- History of allergy or casuistics for study subject or populations: a standardized history (including age, sex, atopic diseases, current and former occupation(s), presumptive causal exposures), along with final diagnoses and site(s) of dermatitis are assessed and documented
Controls:
hydroxymethylpentylcyclohexene carboxaldehyde
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)


ADMINISTRATION
- Testing/scoring schedule: testing for 24 or 48 h; readings until at least 72 h


EXAMINATIONS
- Grading/Scoring system: neg, ?, +, ++, +++, irritant, follicular
- Statistical analysis: Frequencies of sensitization (as % of patients tested) were calculated both as crude proportions and proportions standardized for sex and age. Subgroups of patients defined by sensitization to an index allergen were analysed for concomitant reactions (crude proportions). The reaction index (RI), relating the number of allergic reactions to the number of doubtful or irritant reactions, ranging from RI = -1 (all reactions nonallergic) to RI = + (all reactions being allergic), and the positivity ratio (PR), as the proportion (%) of þ reactions out of the total number of allergic reactions, were calculated as parameters to assess the patch test preparation. A low RI (e.g. -0.8) together with a high PR (e.g. 100%) is indicative of a ‘problematic patch test preparation, where a number of the ‘+’ reactions may be suspected to be falsely positive.

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency: 0.5%


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 9/2003
- Number of subjects with irritating reactions: 6/2003

Any other information on results incl. tables

Results:

Citronellol 1%
Frequencies of sensitization n 2003
n pos 9
% pos 0.5
% pos std 0.4
95% CI 0.1-0.8
Reaction pattern irr/? 6
f 1
+ 8
++ 1
+++ 0
RI 0.1
PR 88.9

Applicant's summary and conclusion

Conclusions:
Authores found Citronellol to be "clearly allergenic but less important in terms of sensitization frequency"