1,1'-iminodipropan-2-ol

Direct observations: clinical cases, poisoning incidents and other

Administrative data

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

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

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

Reason / purpose for cross-reference:

reference to same study

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

Ethical approval:

not specified

Exposure assessment:

not specified

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]

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1980

Reference 2

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1991

Materials and methods

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

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-iminodipropan-2-ol

EC Number:

203-820-9

EC Name:

1,1'-iminodipropan-2-ol

Cas Number:

110-97-4

Molecular formula:

C6H15NO2

IUPAC Name:

1,1'-iminodipropan-2-ol

Details on test material:

no data

Method

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

Results and discussion

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

Any other information on results incl. tables

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.)

Applicant's summary and conclusion

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.