7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Data source

Reference

Reference Type:

publication

Title:

Patch test reactions to Biobans in metalworkers are often weak and not reproducible.

Author:

Brinkmeier, T., Geier, J., Lepoittevin, J.P., and Frosch, P.J.

Year:

2002

Bibliographic source:

Contact Dermatitis, 47, 27-31.

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole

EC Number:

231-810-4

EC Name:

7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole

Cas Number:

7747-35-5

Molecular formula:

C7H13NO2

IUPAC Name:

7a-ethyl-tetrahydro-1H-[1,3]oxazolo[3,4-c][1,3]oxazole

Method

Type of population:

occupational

Route of administration:

dermal

Results and discussion

Results of examinations:

In 408 metalworkers, 14 (3.4%) showed positive reactions to Biobans (2% to CS-1246). Upon retesting, the reactions were confirmed in only 2 cases (P1487 and CS1135). Four patients showed reactions to 3 Biobans (P1487, CS1246, and CS1135), while 9 patients had only solitary sensitizations.
Concomitant sensitizations to formaldehyde were present in 5/10 patients, being reproducible in only 3. In the IVDK data, sensitization prevalence in 3400 patients ranged fro 1.8% (P1487) to 0.8% (CS-1246). A high proportion of doubtful or weak reactions were observed.

Low cross-reactivity between Biobans was low, moderate agreement being calculated for CS1135 and CS1246 (kappa coefficient of 0.43). The consensus pattern between Biobans and formaldehyde was even lower.

Patch test reactions to Biobans are not rare among metalworkers, but are often weak and/or not reproducible.