2-(4-tert-butylbenzyl)propionaldehyde

Sensitisation data (human)

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

Constituent 2

Reference substance name:

2-(4-tert-butylbenzyl)propionaldehyde

EC Number:

201-289-8

EC Name:

2-(4-tert-butylbenzyl)propionaldehyde

Cas Number:

80-54-6

Molecular formula:

C14H20O

IUPAC Name:

3-(4-tert-butylphenyl)-2-methylpropanal

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