Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
review article or handbook
Title:
Skin sensitizing properties of the ethanolamines mono-, di- and triethanolamine. Data analysis of a multicentre surveillance network (IVDK) and review of literature
Author:
Lessmann H, et al.
Year:
2009
Bibliographic source:
Contact Dermatitis, 60, 243-255

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Patch test results with TEA on patients collected from 1992 to 2007 were evaluated
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triethanolamine
- no further data given

Method

Type of population:
general
Ethical approval:
not specified
Route of administration:
dermal

Results and discussion

Results of examinations:
The positive reactions interpreted as allergic seem to be caused by exposure to TEA in cosmetics and/or topical therapeutic preparations possibly on damaged skin. The diagnosis of TEA contact sensitisation should therefore not be based on a positive patch test reaction alone but on a combination of history and – preferably – validation tests. The negative experimental findings in animals and the level of exposure to TEA in the population, the low frequency of positive reactions to low TEA concentrations in patch-tested patients indicates a very low sensitisation potential in humans, and the risk of sensitisation to TEA on uncompromised skin seems to be very low.

Any other information on results incl. tables

In total 85098 patients were tested with TEA. Of these 323 (0.35%) patients were tested positively to TEA. The reaction index was calculated to -0.49. Most of the reactions were weak positive reactions resulting in a high positive ratio (89.5%).

Frequencies of reactions to TEA in all patients tested from 1992 -2007

DEA (n = 85098)

count

[%]

negative

83830

98.5

irritant

106

0.1

questionable

773

0.9

follicular

66

0.1

+

289

0.3

++

30

0.04

+++

4

0.005

reaction index

-0.49

positivity ratio

89.5%

Regarding the MOAHLFA index, there were only minor differences between patients with positive and those without positive reactions to the diethanolamine.

MOAHLFA-Index Frequency of characteristics (%) in TEA-positive (cases) vs. non positive (controls) patients

TEA

cases

controls

Men

49.5

37.8

Occupational dermatitis

23.2

15.5

Atopic dermatitis

18.6

18.8

Hand dermatitis

36.5

30.4

Leg dermatitis

13.9

13.2

Face dermatitis

16.7

16.1

Age ≥ 40 years

69.0

64.7

Reactions to DEA and occupational exposure (metal workers)

If the prevalence of positive reactions in probably water-based metalworking fluids-exposed current male cutting workers is compared with the prevalence in all male patients not working in the metal industry at present, about five to sevenfold higher portion of positive reactions is recorded for MEA and DEA, respectively. For TEA, the prevalence is increased about three times with only 10 patients showing a (weakly) positive reaction.

Reactions to DEA associated with other (non-)occupational applications

In accordance with the unremarkable proportion of occupation-related cases, there were no distinctly different patterns of occupations inTEA-positive versus non-positive patients. There was no difference between the TEA-positive and theTEA non-positive subgroup of patients with regard to the frequencies of suspected causative exposures, such as a similar proportion of about 60% regarding presumable causation of contact dermatitis by cosmetics and topical therapeutics. The association between sporadic sensitization to TEA from exposure to cosmetics or topical

therapeutics is reflected by the high proportion of concomitant reactions to some substances, which are mainly used in these fields, that is fragrance mix (and Myroxylon pereirae), lanolin alcohol and cetearyl alcohol, and parabens. However, concomitant reactions indicating possibly

false-positive, irritant reactions have also been documented, for example for octyl gallate, phenyl mercuric acetate, propylene glycol, and cocamidopropyl betaine.

Applicant's summary and conclusion