Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Clinical allergy report, GLP and guidelines do not apply
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1977

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline required
Deviations:
not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
not reported

Method

Type of population:
occupational
Ethical approval:
not applicable
Subjects:
- Number of subjects exposed: 7
- printers
- no further details
Clinical history:
- Symptoms, onset and progress of the disease: contact eczema on hands and fingers
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: not described
- Vehicle / solvent: 100 % alcohol, toluene/ ol.olivae (1:1), MEK
- Concentrations: 5%
- Volume applied: not described
- Testing/scoring schedule: not described
- Removal of test substance: not described

EXAMINATIONS
- Grading/Scoring system: not described
- Statistical analysis: not described

Results and discussion

Results of examinations:
All seven individuals reacted separately to both PETMP and 3-MPA.

Any other information on results incl. tables

Which of the two should be considered as the inducer of contact sensitization and which only as secondary allergen (cross reactor) remains unknown until human maximization tests have been performed with one of the individual substances in the rest of the industrial mixture.

Applicant's summary and conclusion

Conclusions:
PETMP and 3-MPA were identified as sensitizing components in the Letterflex urethane photoprepolymer mixture.