Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine

Sensitisation data (human)

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

Test material information

Constituent 1

Reference substance name:

triethanolamine

IUPAC Name:

triethanolamine

Constituent 2

Reference substance name:

2,2',2''-nitrilotriethanol

EC Number:

203-049-8

EC Name:

2,2',2''-nitrilotriethanol

Cas Number:

102-71-6

Molecular formula:

C6H15NO3

IUPAC Name:

2,2',2''-nitrilotriethanol

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.