Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)

Data source

Reference
Reference Type:
publication
Title:
Allergic Contact Dermatits from Ultraviolett Cured Inks
Author:
Edward A. Emmett, M.b. and John R. Kominsky, M.S.
Year:
1977
Bibliographic source:
Journal of Occupational Medicine/Vol. 19, No. 2/Feb 1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The materials to be tested were applied to the upper back on the central gauze portion of 3.8 sq cm square patch test plasters occluded with hypoallergenic surgical tape. Patches were removed 48 hours after application and readings were made one hour after removal. Please refer to original literature for further information.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Weight of evidence based on available human data from public available publication

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
human
Strain:
other: Subgroup of sensitized workers working in manufacturing of ultraviolet cured inks
Sex:
not specified
Details on test animals and environmental conditions:
human patch test with volunteers, no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: sensitised worker
Vehicle:
petrolatum
Concentration / amount:
1%
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
Concentration / amount:
1%
No. of animals per dose:
8 humans
Details on study design:
The materials to be tested were applied to the upper back on the central gauze portion of 3.8 sq cm square patch test
plasters occluded with hypoallergenic surgical tape. Patches were removed 48 hours after application and readings were made one hour after removal
Challenge controls:
no
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
7
Total no. in group:
8
Clinical observations:
strong to extreme reactions were recorded
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 7.0. Total no. in groups: 8.0. Clinical observations: strong to extreme reactions were recorded.

Any other information on results incl. tables

A already sensitized subgroup of workers was used for sensiblisation patch testing. Seven of the eight affected employees had unequivocal positive reactions to 1% trimethylol propane triacrylate in petrolatum.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Contact dermatits can be developed by some workers during working with TMPTA or components used in the manufacturing of ultraviolet cured inks
Executive summary:

A sensitized subgroup of workers (working in the manufacturing of uv cured inks) was used for sensitisation patch testing. Seven of the eight affected employees had unequivocal positive reactions to 1% trimethylol propane triacrylate in petrolatum. According to the author it is concluded that triacrylate propane triacrylate appear to be strong allergens capable of sensitizing a significant percentage of the workforce exposed to them over a relatively short period of time. Nevertheless the author hints to the possiblity that some of the observed reactions represent cross reactions. According to the applicant the study does not confirm the induction with

triacrylate propane triacrylate and as cross sensitization with/for other acrylate allergens are reported it is possible that other substance induced the allergy. Additional the the simultaneous exposure in this industry to phototoxic materials and to the acrylate monomers and oligomers may enhance the sensitizing ability of the acrylates. Nevertheless worker working in the manufacturing of uv cured inks are potentially exposed to materials leading to a contact dermatitis with triacrylate propane triacrylate. Because of their allergenicity the the polyfunctional acrylate monomers and epoxy acrylate oligomers should be handled carefully with precautions.