Fatty acids, essential, Et esters

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication meeting basic scientific principles

Data source

Reference

Reference Type:

publication

Title:

Patch test results with the metalworking fluid series of the German Contact Dermatitis Research Group (DKG)

Author:

Geier, J.

Year:

2004

Bibliographic source:

Contact Dermatitis 51: 118–130

Materials and methods

Type of sensitisation studied:

skin

Study type:

survey

Principles of method if other than guideline:

Based on the information of the interdisciplinary task force on allergy diagnostics in the metal branch, in 2001, the German Contact Dermatitis Research Group (DKG) compiled two metalworking fluid (MWF) test series with currently and previously used components, respectively. After 2 years of patch testing, the results obtained with these series were presented, based on data of the Information Network of Departments of Dermatology (IVDK). The patch test guidelines provided from ICDRG and DKG were followed.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl myristate

EC Number:

203-751-4

EC Name:

Isopropyl myristate

Cas Number:

110-27-0

IUPAC Name:

isopropyl myristate

Details on test material:

- Name of test material (as cited in study report): Isopropyl myristate
- CAS No. of test material (as cited in study report): 110-27-0
Patch test substances were obtained from Hermal, Reinbek, Germany.

Method

Type of population:

occupational

Ethical approval:

not specified

Subjects:

As study group, exclusively metalworkers tested because of suspected MWF dermatitis were selected.
In 2002 and 2003, altogether 16 848 patients were patch tested in the departments of dermatology forming the IVDK.
Of these patients, 251 (1.5%) fulfilled the criteria of the study and hence were included in this retrospective data analysis.
Of these, 206 were tested with the current MWF series and 155 with the historical MWF series.
The IVDK is a multicentre surveillance system on contact allergies, with more than 40 departments of dermatology in Germany, Austria and Switzer-
land participating. Patch test results and anamnestic data of all patients tested are recorded electronically in a standardized way and regularly trans-ferred to the IVDK data centre at the University of Göttingen.

Among the study group, i.e. 251 metalworkers tested because of suspected MWF dermatitis, there were 63 turners (lathe operators) (25.1%), 26 milling cutters (10.4%), 25 tool makers (10.0%) and 6 grinders (2.4%). In the remainder, no specification was given beyond ‘metalworker, chipping technology’ or ‘machine operator in the metalworking branch’. 124 patients (49.4%) had been working in their occupation since before 1994, while 82 patients (32.7%) started working with MWF in 1994 or later. In the remaining 45 patients (17.9%), the beginning of the MWF exposure was not mentioned. In the study population, there were 231 men (92.0%) and 115 patients (45.8%) at the age of 40 years or more. The age ranged from 17 to 62 years with a median of 38years (mean 38.8_11.4 years). 74 patients (29.5%) were examined in the context of a medicolegal assessment. 47 patients (18.7%) had past or present atopic dermatitis. 201 patients (80.1%) suffered from hand dermatitis. According to the course and anatomical site of the skin disease on the one hand and the occupational exposure (and, partly, occupational contact allergies) on the other hand, occupational dermatitis was finally diagnosed in 187 patients (74.5%). A final current diagnosis of ICD was made in 81 patients
(32.3%), while ACD was diagnosed in 63 patients (25.1%). The remainder currently had various other forms of skin disease, e.g. dyshidrotic eczema, atopic dermatitis [22 patients (8.8%) each] or psoriasis [5 patients (2.2%)], etc.

Clinical history:

74 patients (29.5%) were examined in the context of a medicolegal assessment. 47 patients (18.7%) had past or present atopic dermatitis. 201 patients (80.1%) suffered from hand dermatitis. According to the course and anatomical site of the skin disease on the one hand and the occupational exposure (and, partly, occupational contact allergies) on the other hand, occupational dermatitis was finally diagnosed in 187 patients (74.5%). A final current diagnosis of ICD was made in 81 patients
(32.3%), while ACD was diagnosed in 63 patients (25.1%). The remainder currently had various other forms of skin disease, e.g. dyshidrotic eczema, atopic dermatitis [22 patients (8.8%) each] or psoriasis [5 patients (2.2%)], etc.

Controls:

No controls performed

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test) ;
Patch tests were performed and read at least until day 3 (D3), according to the guidelines of the ICDRG and the DKG (Schnuch, 2001 and Wahlberg, 2001). Patch test exposure time was 2 days in 208 patients (83%) and 1 day in 43 patients (17%) according to the routine test procedure in the respective centre.

ADMINISTRATION

- Vehicle / solvent: petrolatum
- Concentrations: 10%
- No. of patients tested with isopropyl myristate: 196

Results and discussion

Results of examinations:

No positive reactions were seen to isopropyl myristate (0 out of 196 patients with reactions).
The test series with current MWF allergens has to be kept up-to-date based on information from industry and to be kept concise by eliminating test substances which never cause positive reactions.

Any other information on results incl. tables

The test series with current MWF allergens was tested in 206 patients (82.1% of the study population), and 88 positive reactions to allergens of this series occurred in 48 patients (23.3% of 206). Among those 155 patients (61.8%) tested with the series containing former, historical MWF allergens, 19 positive reactions were seen in 16 patients (10.3% of 155). The DKG standard series was patch tested in 221 patients (88.0% of the study population), and 128 positive patch test reactions occurred in 77 of these patients (34.8%).

Applicant's summary and conclusion

Conclusions:

10% isopropyl myristate in petrolatum was not sensitising to the skin of 196 patients.