Registration Dossier

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:
2006

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

Constituent 1
Chemical structure
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:
1,4-bis(2-ethylhexyl) (2Z)-but-2-enedioate
Constituent 2
Chemical structure
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.

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.