Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
other information
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference Type:
Contact dermatitis from spectacle frames and hearing aid containing diethyl phthalate
S. Oliwiecki, M.H. Beck and R.J.G. Chalmers
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

Constituent 1
Chemical structure
Reference substance name:
Dimethyl phthalate
EC Number:
EC Name:
Dimethyl phthalate
Cas Number:
Molecular formula:
1,2-dimethyl benzene-1,2-dicarboxylate
Test material form:
Specific details on test material used for the study:
no further details given


Type of population:
Ethical approval:
not applicable
Route of exposure:

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

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.