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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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Occupational allergic contact dermatitis caused by exposure to acrylates during work with dental prostheses
Author:
Kanerva L, Estlander T, Jolanki R, Tarvainen K
Year:
1993
Bibliographic source:
Contact. Derm. 28: 268-275

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
3 patients (24-32 years old) with allergic occupational contact dermatitis caused by exposure to acrylates during work with dental protheses were patch tested with 2-ethylhexyl methacrylate (1% in petrolatum)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl methacrylate
EC Number:
211-708-6
EC Name:
2-ethylhexyl methacrylate
Cas Number:
688-84-6
Molecular formula:
C12H22O2
IUPAC Name:
2-ethylhexyl methacrylate
Test material form:
liquid

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 4
- Sex: female
- Age: 23-32 years
- Race: no data
- Demographic information: no data
Clinical history:
- History of allergy or casuistics for study subject or populations: occupational contact dermatitis
- Symptoms, onset and progress of the disease: fingertips, hands or face
- Exposure history: 1.5-2 years
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semi-occlusive for 24h
- Description of patch: Finn chamber
- Vehicle / solvent: petrolatum
- Concentrations: 1%
- Volume applied: no data
- Testing/scoring schedule: on removal and 24, 48, and 96-120 h after removal
- Removal of test substance: no data

EXAMINATIONS
- Grading/Scoring system: recommendations of the Finnish contact dermatitis group
- Statistical analysis: no data

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: none

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0

Applicant's summary and conclusion

Conclusions:
No patients showed positive allergic skin reactions.