Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
other: case report dermal sensitization
Adequacy of study:
supporting study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose:
reference to same study
Study type:
clinical case study
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
An individual complaining of irritation of her eyelids and face was patch tested with various cosmetics previously used. She only reacted to eye gloss. She was then patch tested with the individual ingredients present in the eye gloss.
GLP compliance:
no
Type of population:
other: individual complained of irritation of her eyelids and face
Subjects:
One female, aged 15 years, complained of irritation of her eyelids and face for six months and attributed this to her cosmetics.
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
other: present in cosmetics used by individual
Exposure assessment:
not specified
Details on exposure:
Individual complained of irritation of her eyelids and face for six months. Presume exposure was at least 6 months.
Examinations:
No information provided other than patch testing of cosmetics used by individual. Since eye gloss tested positive, the ingredients present in eye gloss were individually tested.
Medical treatment:
No information provided
Clinical signs:
In a separate study conducted on 24 control subjects, diisopropanolamine when tested undiluted produced irritant responses in six individuals.

When undiluted diisopropanolamine was tested on the individual complaining of irritation of her eyelids and face, the physician reported it gave a positive open test. The physician considered the response to be more severe than just due to irritation since it was eczematous and spread beyond the patch test site.
Results of examinations:
Undiluted DIPA when tested in 24 control subjects produced an irritant response in six individuals.

Even though DIPA was tested undiluted on the individual with irritation of eyelids and face, the response was considered to be more severe than just due to irritation. The physician considered it to be an allergic response.
Effectivity of medical treatment:
no information provided
Outcome of incidence:
no information provided

A 15 year old girl reportedly had an allergic response to undiluted diisopropanolamine.

(Six out of 24 control subjects exhibited irritant responses when patch tested with undiluted diisopropanolamine.)

Executive summary:

A girl, aged 15 years, complained of irritation of her eyelids and face for six months and attributed this to her cosmetics (Cronin, 1980). When patch tested, she reacted only to her eye gloss; she was then tested to its ingredients, and reacted to diisopropanolamine, undiluted. This substance also gave a positive open test; as it is an irritant, it should have been diluted for patch testing. It was, in fact, tested undiluted on 24 control subjects of whom six gave irritant responses. Nevertheless, the patient's reaction did not look irritant, it was eczematous and spread beyond the patch test site; for this reason it was considered an allergic response.

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
No information
Author:
Cronin E
Year:
1980
Bibliographic source:
Contact Dermatitis, Churchill Livingstone, Edinburgh
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1991

Materials and methods

Type of study / information:
human patch test
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
Human patch test with neat diisopropanolamine or 1% aqueous solution to 24 or 61 volunteers, respectively.
No further details.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Ethical approval:
not specified
Exposure assessment:
not specified

Results and discussion

Results:
Six out of 24 volunteers exhibited irritant responses when patch tested with neat diisopropanolamine (Cronin, 1973: Contact Dermatitis Newsletter 13, 364; cited in Cronin, 1980), but no irritation occurred in a group of 61 volunteers tested with a 1% aqueous solution (Cronin, 1980, Contact Dermatitis. Churchill Livingstone, Edinburgh).
[No further details on test conditions were given for either study]

Applicant's summary and conclusion