Registration Dossier
Registration Dossier
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EC number: 205-011-6 | CAS number: 131-11-3
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact dermatitis from spectacle frames and hearing aid containing diethyl phthalate
- Author:
- S. Oliwiecki, M.H. Beck and R.J.G. Chalmers
- Year:
- 1 991
- Bibliographic source:
- Contact Dermatitis 1991: 25: 265
Materials and methods
- Study type:
- clinical case study
- Endpoint addressed:
- skin sensitisation
- Principles of method if other than guideline:
- A 71-year-old housewife had worn a hearing aid for several years and had since suffered recurrent ear infections. A year before presentation, she developed dematitis on the temples and behind the ears, where there was contact with the side-arms of her spectacle frames. She was patch tested with an extended European standard series, an ear series, a spectacle frame series, Chemotechnique acrylic and plastics and glues series, polyester resin 10% pet., benzoyl peroxide 1% pet., and scrapings from her spectacle frames and hearing aid.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dimethyl phthalate
- EC Number:
- 205-011-6
- EC Name:
- Dimethyl phthalate
- Cas Number:
- 131-11-3
- Molecular formula:
- C10H10O4
- IUPAC Name:
- 1,2-dimethyl benzene-1,2-dicarboxylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- no further details given
Method
- Type of population:
- general
- Ethical approval:
- not applicable
- Route of exposure:
- dermal
Results and discussion
Any other information on results incl. tables
Positive results for dimethyl phthalate 5% pet. patch tests read at 2 and 4 days.
Applicant's summary and conclusion
- Conclusions:
- DMP was not sensitising in an OET. The strucurally related analogue DEP was not sensitising in an LLNA and a Buehler test. DMP did not cause positive patch test reactions in several studies and failed to induce sensitization in humans. Although the reliability of most of the studies is limited, the incident of one positive reaction in this present study can be seen as an extraordinary rare event und therefore most probably coincidential. Furthermore the reliability of this present study is not assessable due to insufficient documentation.
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