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Toxicological information

Health surveillance data

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Administrative data

Endpoint:
health surveillance data
Type of information:
other: case report
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This is case report of adverse effects in an occupational setting. It is reliable with restrictions that no cause and effect can be proven with this information.

Data source

Reference
Reference Type:
publication
Title:
Allergic Contact Dermatitis from dicyclohexylmethane-4,4'-diisocyanate
Author:
Frick M, Björkner B, Hamnerius N, Zimerson E.
Year:
2003
Bibliographic source:
Contact Dermatitis. 48(6): 305-9

Materials and methods

Study type:
other: case report
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Case report. No guideline is available.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
no data on purity

Method

Type of population:
occupational
Ethical approval:
not applicable
Details on study design:
Employees referred for medical evaluation of adverse effects were patch tested with the standard European series supplemented with several additional chemicals, including DMDI (1% w/w petrolatum) and PACM (0.1% or 0.5% in petrolatum), using a Finn chamber with Scanpor tape. Tests were removed after 2 days and read after 1 day, according to standard (ICDRG) criteria. In 7 (of 16) cases, a second reading was done 7 days after the initial application of patches.

Results and discussion

Results:
Contact allergy was demonstrated from occupational exposure to a glue containing isocyanates. A minor component of the glue mixture is 4,4'-methylenedicyclohexanamine (PACM). The substance which was demonstrated in later skin testing to be mainly responsible was isocyanate dicyclohexylmethane-4,4'diisocyanate. None of these patients (13 of 100) reacted to the other constituent, toluene diisocyante (TDI). Five patients showed simultaneous reactions to DMDI and DMDA (PACM). Nine patients also reacted to 1,6-hexamethylenediisocyanate (HDI), 4 to isophoronediisocyanate (IPDI), 1 to isophorone diamine (IPDA) and 5 to MDA. In 4 patients no work- or isocyanate-related allergy could be demonstrated.

Applicant's summary and conclusion

Conclusions:
Contact allergy has been demonstrated from occupational exposure to a glue containing isocyanates. A minor component of the glue mixture is 4,4'-methylenedicyclohexanamine (PACM). The substance which was demonstrated in later skin testing to be mainly responsible was isocyanate dicyclohexylmethane-4,4'diisocyanate (DMDI). Five (of 16) reactive patients showed simultaneous reactions to DMDI and DMDA (PACM). As isocyanates are known to be strong dermal sensitisers, this study suggests that components of epoxy resins other than PACM may be the cause of adverse dermal effects.