Registration Dossier
Registration Dossier
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EC number: 205-524-5 | CAS number: 142-16-5
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Insufficient detail on experimental procedure and results.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- case report
- Principles of method if other than guideline:
- Patch testing according to the British Contact Dermatitis Society standard series.
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(2-ethylhexyl) maleate
- EC Number:
- 205-524-5
- EC Name:
- Bis(2-ethylhexyl) maleate
- Cas Number:
- 142-16-5
- Molecular formula:
- C20H36O4
- IUPAC Name:
- bis(2-ethylhexyl) but-2-enedioate
- Reference substance name:
- Dioctyl maleate
- EC Number:
- 220-835-6
- EC Name:
- Dioctyl maleate
- Cas Number:
- 2915-53-9
- Molecular formula:
- C20H36O4
- IUPAC Name:
- dioctyl but-2-enedioate
- Details on test material:
- 2%, 5% and 10% of dioctyl maletate in petrolatum.
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Ethical approval:
- not applicable
- Subjects:
- A 62-year old woman.
- Clinical history:
- Two year history of severe intermittent facial dermatitis associated with an itchym burning sensation and oedema.
- Controls:
- Yes but no data.
- Route of administration:
- dermal
- Details on study design:
- Patch testing according to the British Contact Dermatitis Society standards series. Individual ingredients of the moisturizing lotion containing 2, 5 and 10% dioctyl maleate in petrolatum was tested. 15 control patients were included.
Results and discussion
- Results of examinations:
- Patch testing with 2,5 and 10% dioctyl maleate in petrolatum showed a strong positive reaction. Patch testing in control patients was negative.
Applicant's summary and conclusion
- Conclusions:
- Authors suggested that dioctyl maleate is an allergen or skin sensitizer in humans.
- Executive summary:
A 62-year old woman with a history of severe intermittent facial dermatitis including itchy, burning sensation and oedema was reported. A patch testing was conducted to individual ingredients of the moisturizing lotion containing 2, 5, and 10% of dioctyl maleate in petrolatum. Patch testing showed positive reaction to dioctyl maleate at all concentrations. Control patients with petrolatum were negative. Authors suggested that dioctyl maleate was a skin sensitizer.
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