Registration Dossier
Registration Dossier
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EC number: 249-204-3 | CAS number: 28768-32-3
Sensitisation data (human)
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:
- 1 984
- 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
- 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
- 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
Constituent 1
Constituent 2
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.
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