Isooctadecanoic acid, monoester with glycerol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1999

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only short abstract available. Summary of case report lacking materials and methods, no clear substance identity.

Data source

Reference

Reference Type:

publication

Title:

Recurrent contact cheilitis because of glyceryl isostearate, diisostearyl maleate, oleyl alcohol, and Lithol Rubine BCA in lipsticks

Author:

Inui, S. et al.

Year:

2009

Bibliographic source:

Contact Dermatitis 60:231 - 232

Materials and methods

Type of sensitisation studied:

skin

Study type:

case report

Principles of method if other than guideline:

A subject presented with a history of persistent itchy and scaly erythema on the lips, lasting several years. Patch testing was performed initially with cosmetic products (lipsticks) suspected to have caused the skin reaction. Subsequently, patch testing was performed using the individual ingredients of lipsticks that caused a positive skin reaction. The substance(s) provoking renewed positive skin reaction could then be identified as the cause of the allergic contact dermatitis.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

glyceryl isostearate

IUPAC Name:

glyceryl isostearate

Details on test material:

- Name of test material (as cited in study report): glyceryl isostearate
- Analytical purity: no data

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 1
- Sex: female
- Age: 28

Clinical history:

- History of allergy or casuistics for study subject or populations: subject had experienced erythema or symptoms indicative of allergic contact dermatitis for several years prior to the patch testing
- Symptoms, onset and progress of the disease: symptoms (erythema of the lips, including itching, scaling) started several years prior to presentation

Controls:

3 persons were used as negative control

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Concentrations: lipsticks were tested undiluted; 10% pet oleyl alcohol, 1% pet glyceryl isostearate, 40% pet diisostearyl maleate, 1% pet Lithol Rubine BCA
- Volume applied: no data
- Other: patch testing was performed with: lipsticks A-E (patient’s own), 10% pet oleyl alcohol, 1% pet glyceryl isostearate, 40% pet diisostearyl maleate, 1% pet Lithol Rubine BCA

EXAMINATIONS
- Grading/Scoring system: skin effct were scored on Day 2 and Day 3, the scoring system is not given

The test samples of oleyl alcohol, glyceryl isostearate, diisostearly maleate, Lithol Rubine BCA were provided by the manufacturers of lipstick D and E.

Results and discussion

Results of examinations:

RESULT OF CASE REPORT:
A subject presented with a history of persistent itchy and scaly erythema on the lips, lasting several years. Patch testing was performed initially with cosmetic products (lipsticks) suspected to have caused the skin reaction. Subsequently, patch testing was performed using the individual ingredients of lipsticks that caused a positive skin reaction. Patch testing was performed on the subject; with cosmetic products suspected to have caused the skin reaction and with the individual ingredients of two lipsticks that caused a positive skin reaction. Glyceryl isostearate, oleyl alcohol, diisostearyl maleate and Lithol Rubine BCA provoked positive skin reactions and were identified as the cause of the allergic contact dermatitis.

Patch test results:
The results were positive for all lipsticks, at the Day 2 and Day 3-hour reading time point (see table 1 “any other information on results including tables”).
Results for glyceryl isostearate and oleyl alcohol were inconclusive for the Day 2- and positive for the Day 3- reading time point. For diisostearyl maleate and Lithol Rubine BCA the results were negative at the Day 2-hour reading time point and positive at the Day 3-hour reading time point.

Because the molecular structure of glyceryl isostearate was not defined and there was no CAS number listed in the publication, it is unclear whether the branching, substance definition and composition is the same as for the branching defined for CAS 66085-00-5.

Any other information on results incl. tables

Table 1

Allergens	Concentration	Day 2	Day 3
Lipstick A*	As is	+	++
Lipstick B*	As is	+	++
Lipstick C*	As is	+	+
Lipstick D*	As is	+	++
Lipstick E*	As is	+	+
glyceryl isostearate	1% pet	+?	+
oleyl alcohol	10% pet	+?	+
diisostearate maleate	40% pet	-	+
Lithol Rubine BCA	1% pet	-	+
Other ingredients of D and E		-	-

*Patient’s own

Applicant's summary and conclusion

Conclusions:

A subject presented with allergic contact dermatitis as a persistent erythema on the lips that had persisted for several years. Patch testing was performed with cosmetic products and cosmetics ingredients suspected to have caused the skin reaction. Glyceryl isostearate provoked a positive skin reaction at 1% pet, as did several other substances. Because the molecular structure of glyceryl isostearate was not defined and no CAS number was listed in the publication, it is unclear whether the branching, substance definition and composition is the same as for the branching defined for CAS 66085-00-5.