Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A reasonably well reported study that conforms to basic scientific principles and contributes to the understanding of the sensitising potential of this substance.

Data source

Reference
Reference Type:
publication
Title:
Can chemicals precipitate dermatitis herpetiformis ?
Author:
Snider RL and Maize JC
Year:
1993
Bibliographic source:
J. Am. Acad. Of Dermatology, 28 (1), 111-112.

Materials and methods

Study type:
health record from industry
Endpoint addressed:
dermal absorption
skin irritation / corrosion
skin sensitisation
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Not applicable - health record from industry
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
An industrial cleaner. Analysis of the mixture showed the presence of 2-butoxyethanol, trisodium phosphate, nonylphenol polyethylene glycol ether, anthraquinone, lemon fragrance and an antifoam agent.

Method

Type of population:
occupational
Ethical approval:
not specified
Details on study design:
Patch testing on unaffected skin of the back was carried out with the individual chemicals of the mixture and at the same concentration than in the mixture (except for 2-butoxyethanol which was diluted to avoid irritation)

Results and discussion

Results:
The substance2-(2-(2-butoxyethoxy)ethoxy)ethanol is an analogue of the test substance used in the study.Two cases of dermatitis herpetiformis (DH) temporally related to the use of a cleaning solution containing 2 -butoxyethanol (2BE) have been reported. Analysis of the mixture showed the presence of 2 -butoxyethanol amongst a number of other materials. Patch testing was carried out with the individual chemicals at the same concentration than in the mixture, except for 2BE which was diluted to avoid irritation). There was no reported reaction to 2 -butoxyethanol in the patch tests whereas some of the other chemicals caused an adverse response.

Applicant's summary and conclusion

Conclusions:
The substance 2-(2-(2-butoxyethoxy)ethoxy)ethanol is an analogue of the test substance used in the study.2-butoxyethanol was not the cause of dermatitis herpetiformis in two occupational case studies.
Executive summary:

The substance2-(2-(2-butoxyethoxy)ethoxy)ethanol is an analogue of the test substance used in the study.Two cases of dermatitis herpetiformis (DH) temporally related to the use of a cleaning solution containing 2 -butoxyethanol (2BE) have been reported. Analysis of the mixture showed the presence of 2 -butoxyethanol amongst a number of other materials. Patch testing was carried out with the individual chemicals at the same concentration than in the mixture, except for 2BE which was diluted to avoid irritation). There was no reported reaction to 2 -butoxyethanol in the patch tests whereas some of the other chemicals caused an adverse response.