Registration Dossier
Registration Dossier
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EC number: 216-768-7 | CAS number: 1663-39-4
Sensitisation data (human)
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:
- Sensitization to patch test acrylates.
- Author:
- Kanerva L, Estlander T, Jolanki R, Tarvainen K
- Year:
- 1 993
- Bibliographic source:
- Contact Dermatitis 28: 268-275
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- survey
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- During 1982-1985 a project dealing with hand dermatitis in dental technicians was started using a skin sensitization tester set of 7 different acrylates.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- tert-butyl acrylate
- EC Number:
- 216-768-7
- EC Name:
- tert-butyl acrylate
- Cas Number:
- 1663-39-4
- Molecular formula:
- C7H12O2
- IUPAC Name:
- tert-butyl acrylate
Constituent 1
- Specific details on test material used for the study:
- Purity unknown
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 22
- Clinical history:
- Contact dermatitis
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: The Finn-chamber method with an occlusion time of 24 h was used. The tests were applied on the back with a non-occlusive porous tape (Scanpor® Surgical Tape, Norgeplaster A/S, Norway); or when the back was full of patch tests, the thighs were used.
- Vehicle / solvent: petrolatum
- Concentrations: 1 %
- Testing/scoring schedule: The tests were read on removal and 24 h, 48 h, and 96-120 h after removal (at least 3 readings).
Results and discussion
- Results of examinations:
- During 1982-1985, 1 out of 22 patients with contact dermatitis tested with 7 different acrylates showed a positive patch test reaction to tert-butyl acrylate (1 % in petrolatum) and one showed slight to moderate irritation at 24 h.
Applicant's summary and conclusion
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