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Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
October 1997 - October 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well described publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Further important sensitizers in patients sensitive to fragrances: I. Reactivity to 14 frequently used chemicals
Author:
Frosch P.J., Johansen J.D., Menné T., Pirker C., Rasogi S.C., Andersen K.E., Bruze M., Goosens A., Lepoittevin J.P. White I.R
Year:
2002
Bibliographic source:
Contact Dermatitis 2002, 47, 78-85
Reference Type:
secondary source
Title:
Further important sensitizers in patients sensitive to fragrances: I. Reactivity to 14 frequently used chemicals
Author:
Frosch P.J., Johansen J.D., Menné T., Pirker C., Rasogi S.C., Andersen K.E., Bruze M., Goosens A., Lepoittevin J.P. White I.R
Year:
2002
Bibliographic source:
Contact Dermatitis 2002, 47, 78-85 [as cited in RIFM and FEMA Fragrance and Flavour Database (online), 188, Location 41242, updated 28-Sep-07]

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human Patch Test with individuals who had a history of adverse reaction to fragrances
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name as cited in document: Lilial (2-methyl-3(4-tert-butylphenyl)propanal
- Analytical purity: => 95
- Source: Dragoco (Holzminden, Germany)

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 1855

Clinical history:
Each patient was placed in 1 of 4 categories (certain, probable, questionable and none) according to a history of adverse reactions to fragrances as described in Frosch et al. 1999. This history was taken before the patch testing procedure.

Frosch P J, Johansen J D, Menné T et al. Lyral is an important sensitizer in patients sensitive to fragrances. Br J Dermatol 1999: 141: 1076-1083
Controls:
Fragrance mix (8%) supplied by Hermal, Reinbek, Germany (Larsen in 1977, Arch Dermatol 1977 : 113 : 623-626)
Route of administration:
dermal
Details on study design:
The tests were performed in 6 dermatological centres across europe (Dortmund, Copenhagen, Malmo, Odense, London and Leuven). A total of 14 fragrance compounds (termed: series I) were tested in the study.

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: no data
- Site of application: skin of the back
- Description of patch: Finn Chambers on Scanpor and van der Bend chambers (only in Leuven)
- Vehicle: petrolatum
- Concentrations: 10% (based on literature reports and pilot testing performed in 4 centres (Copenhagen, Dortmund, Malmoe, London)
- Volume applied: no data
- Duration of application: 2 days
- Testing/scoring schedule: reading were taken at most centers on day 2 and day 4. The reading on day 3 or day 4 was used for overall evaluation of positive test results
- Removal of test substance: no details given

EXAMINATIONS
- Grading/Scoring system: according to published guidelines (Wahlberg J E. Patch testing In: Rycroft R.J.G, Menné T., Lepoittevin J.P., eds . Textbook of Contact Dermatitis, 3rd edn . Heidelberg : Springer, 2001 : 435-468
- Statistical analysis: no data

Results and discussion

Results of examinations:
RESULT OF CASE REPORT: see table 1

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION: see table 2

- 3 cases of positive reaction to Lysmeral. In the 2 with a + + reaction, the fragrance mix (FM) was positive only in 1; this patient also had a certain fragrance history, while the other 2 patients had a questionable and no history, respectively.

Any other information on results incl. tables

Table 1: History of adverse reaction to fragrances of the patients involved in the study

Group

History

FM positive

Series I and FM postive

Only Series I positives

Certain

124/1855 (6.6%)

51/124 (41.1%)

15/124 (12.0%)

9/124 (7.2%)

Probable

150/1855 (8.0%)

29/150 (19.3%)

7/150 (4.7%)

6/150 (4.0%)

Questionable

170/1855 (9.2%)

14/170 (8.2%)

7/170 (4.1%)

7/170 (3.5%)

None

1411/1855 (76.1%)

77/1411 (5.4%)

10/1411 (0.7%)

19/1411 (1.3%)

Table 2: Results obtained by testing 1855 consecutive patients. Listed are the numbers of observed reactions

Doubtful

Positive

n

%

+

++

+++

Total

%

FM (8%)

116

6.3

110

80

20

210

11.3

Lysmeral (10%)

12

0.6

1

2

0

3

0.2

Applicant's summary and conclusion