Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation is insufficient for assessment. Few details on the study protocol are given.

Data source

Reference
Reference Type:
publication
Title:
Allergic contact dermatitis from cetearyl isononanoate
Author:
Le Coz C.J. and Bressieux A.
Bibliographic source:
Contact Dermatitis, 2003; 48:343

Materials and methods

Study type:
clinical case study
Endpoint addressed:
other: allergic contact dermatitis
Principles of method if other than guideline:
A woman with a history of allergic contact dermatitis reacted to a moisturising cream. Patch testing was performed using the ingredients in the cream and other known allergens, and repeated open application test (ROAT) was performed with the cream and test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): cetearyl isononanoate, hexadecyl isononanoate
- Analytical purity: no data

Method

Type of population:
other: case report
Ethical approval:
not applicable
Route of exposure:
dermal
Reason of exposure:
accidental
Exposure assessment:
not specified
Details on exposure:
A 23-year old woman with a history of allergic contact dermatitis from medical adhesive tape, toilet waters and fantasy jewellery, presented with acute dermatitis on her lower limbs within 2 days of applying a urea-based moisturising cream. Patch testing was performed according to Lachapelle et al. (Contact Dermatitis 1997; 36:121-123) with the revised international series, other allergens and the cream. Readings on Day 2/4 showed positive reactions to colophonium (-/++), fragrance mix (-/++) and nickel sulfate (-/+) that previously caused reaction and the urea cream (+/++) causing current reaction. A repeated open application test (ROAT) performed with the cream elicited follicular itching dermatitis within 2 days. Patch tests were performed with all the ingredients of the cream, with positive reactions to the cream (++/++) and cetearyl isononanoate diluted to 4% in liquid mineral oil (-/++). 2% cetyl alcohol in liquid mineral oil was negative. A ROAT performed with the 4% cetearyl isononanoate solution applied 2 times/day on the forearm gave a positive reaction (++) after 2 days. 10 voluntary controls tested with 4% cetearyl isononanoate in liquid mineral oil had negative reactions on Day 2/3 and Day 4.

Results and discussion

Outcome of incidence:
The woman tested positive to a patch test and repeated open application test (ROAT) with cetearyl isononanoate diluted to 4% in liquid mineral oil.

Applicant's summary and conclusion