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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: peer-reviewed journal fullhistory of patient
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Contact dermatitis from the epoxy resin tetraglycidyl-4,4'-methylenedianiline (TGMDA) and o-diglycidyyl phthalate (DGP) in composite material.
Author:
Burrows, D. et al.
Year:
1984
Bibliographic source:
Contact Dermatitis 11, 80-82, (1984)
Report date:
1984

Materials and methods

Type of sensitisation studied:
skin
Study type:
survey
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Survey of 25 workers in a factory working for the aircraft industry (epoxy materials including prepregs).
Workers were patch-tested for a variety of epoxy- and other substances.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline]
EC Number:
249-204-3
EC Name:
4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline]
Cas Number:
28768-32-3
Molecular formula:
C25H30N2O4
IUPAC Name:
4-[[4-[bis(oxiran-2-ylmethyl)amino]phenyl]methyl]-N,N-bis(oxiran-2-ylmethyl)aniline
Constituent 2
Reference substance name:
4-[[4-[bis(oxiran-2-ylmethyl)amino]phenyl]methyl]-N,N-bis(oxiran-2-ylmethyl)aniline
IUPAC Name:
4-[[4-[bis(oxiran-2-ylmethyl)amino]phenyl]methyl]-N,N-bis(oxiran-2-ylmethyl)aniline
Details on test material:
no details could be given

Method

Type of population:
occupational
Ethical approval:
not applicable
Subjects:
25 workers in a a facory were screened for allergic dermatitis after several cases were reported.
Many developed allergic dermatitis on hands, forearms, face and eye lids.
Clinical history:
All 25 workers were patch-tested, 14 showed allergic reactions to one or more substances
Controls:
none
Route of administration:
dermal
Details on study design:
Patch testing was done according to general principles for this type of tests. European Standard series of substances are used in a first round before specific chemicals are tested.

Results and discussion

Results of examinations:
of the 25 workers patch-tested 14 showed a positive reaction to one or more substances. allergies to TGMDA developed 7 workers, allergies composite epoxy materials (more than one substance) developed 9 workers

Any other information on results incl. tables

40 control persons showed no reaction to TGMDA and epoxy materials (composites)

Applicant's summary and conclusion

Conclusions:
TGMDA and composite materials in an factory supplying parts to the aircraft industry caused allergic dermatitis in many workers handling these materials.
Executive summary:

TGMDA and composite materials in an factory supplying parts to the aircraft industry caused allergic dermatitis in many workers handling these materials.