2-(2-aminoethoxy)ethanol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

other information

Study period:

April 2000 - July 2002

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

publication

Title:

Patch testing with components of water-based metalworking fluids

Author:

Geier F, Lessmann H, Frosch PJ, Pirker C, Koch P, Aschoff R, Richter G, Becker D, Eckert C, Uter W, Schnuch, Fuschs T

Year:

2003

Bibliographic source:

Contact Dermatitis 2003 : 49: 85-90

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

13 frequently metal working fluid (MWF) components that might be sensitizers were used patch tested in 233 dermatitis patients with present or past occupational exposure to MWF.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-aminoethoxy)ethanol

EC Number:

213-195-4

EC Name:

2-(2-aminoethoxy)ethanol

Cas Number:

929-06-6

Molecular formula:

C4H11NO2

IUPAC Name:

2-(2-aminoethoxy)ethan-1-ol

Method

Type of population:

occupational

Ethical approval:

not specified

Subjects:

- 233 dermatitis patients with present or past occupational exposure to MWF
- Patch testing with the study panel was not restricted to metalworkers with contact dermatitis who are currently exposed to MWF . In order not to miss previously acquired sensitizations to MWF components, we also tested dermatitis patients with previous MWF exposure.
- predominantely male population
mean age of 39.3 years (median 38 years)

Clinical history:

see table 1

Route of administration:

dermal

Details on study design:

- patch test performed according to international guidelines modiefied by DGK (specified in Schnuch A, Aberer W, Agathos M, Brasch J, Frosch P J, Fuchs T H, Richter G . für die Deutsche Kontaktallergie- Gruppe: Leitlinien der Déutschen Dermatologischen Gesellschaft (DDG) zur Durchführung des Epikutantests mit Kontaktallergenen . Hautarzt 2001 : 52 : 864-866)
- Among the 233 tested patients, patch test application time was 1 day in 2 centres (88 patients = 37 .8%), and 2 days in 3 centres ( 145 patients= 62.2%), in line with the routine patch test procedures in the respective clinics .
- All tests were read at least until D3 . For data analysis, only reactions at D3 were selected.
- Data were analysed at the IVDK data centre at the University of Göttingen, using the statistical program system SAS 8.2 (SAS Institute, Cary, NC, USA).

Results and discussion

Results of examinations:

Only 7 patients showed positive reactions to the study panel (Tab. 2). Allergic reactions to the emulsifier diglycolamine [syn. 2-(2-aminoethoxy) ethanol] were seen in 5 patients, and l patient each reacted positively to 2-arnino-2-ethyl-l,3-propanediol (AEPD) and methyldiethanolarnine (MDEA). Clinical relevance of the reactions to diglycolamine was unequivocally proven by its presence in the MWF from the patients' workplace in 3 cases. Diglycolamine seems to be an important MWF allergen, independently from monoethanolamine and diethanolamine. A test·concentration of 1% petrolatum (pet.) appears to be appropriate.

Any other information on results incl. tables

Tab. 2: Test reactions at D3 to the 13 metalworking fluid components

 

Substance		Patients tested	-	?	+	++	% positive
2-(2-aminoethoxy)ethanol (diglycolamine)	1.0% pet.	228	220	3	4	1	2.2
2-amino-2-ethyl-1,3-propanediol (AEPD)	1.0% aq.	160	159		1		0.6
Methyldiethanolamine (MDEA)	1.0% pet.	229	228		1		0.4
2-amino-1-butanol	1.0% pet.	229	229				0.0
2-amino-2-methyl-l-propanol (AMP)	1.0% aq.	160	160				0.0
l-aminopropan-2-ol (monoisopropanolamine)	1.0% pet.	228	228				0.0
2-hexyldecanol- l (isocetyl alcohol)	20.0% pet.	211	211				0.0
Iso-tridecanol	5.0% pet.	229	229				0.0
Oleic acid	5.0% pet.	229	228	1			0.0
l-hydroxyethyl-2-heptadecenyl-imidazoline	0.1% pet.	201	201				0.0
Methyl-!H-benzotriazole, sodium salt	1.0% aq.	125	125				0.0
l ,6-dihydroxy-2,5-dioxahexane	1.0% pet.	201	200	1			0.0
lodopropynyl butylcarbamate (IPBC)	0.1%pet.	228	227	1			0.0

 

Applicant's summary and conclusion

Conclusions:

2-(2-aminoethoxy)ethanol was tested as a 1% preparation in petrolatum in a total of 228 employees of the metal industry in the epicutaneous test. Five of the 228 employees tested (2.8%) showed a positive reaction. For three further tested individuals (1.3%) a questionable reaction was observed.

Executive summary:

Water-based metalworking fluids (MWFs) may cause both irritant and allergic contact dermatitis. Several well-known MWF allergens are available for patch testing, but considering the wide variety of possible components used in MWF, our diagnostic arsenal covers only a small part of potential allergens. We therefore selected 13 frequently used MWF components that might be sensitizers and had not yet been tested routinely. In 5 centres, 233 dermatitis patients with present or past occupational exposure to MWF were patch tested with this and other panels. Only 7 patients showed positive reactions to the study panel. Allergic reactions to the emulsifier diglycolamine [syn. 2-(2-aminoethoxy) ethanol] were seen in 5 patients, and 1 patient each reacted positively to 2-amino-2-ethyl-1,3-propanediol (AEPD) and methyldiethanolarnine (MDEA). Clinical relevance of the reactions to diglycolamine was unequivocally proven by its presence in the MWF from the patients' workplace in 3 cases. Diglycolamine seems to be an important MWF allergen, independently from monoethanolamine and diethanolamine. A test concentration of 1% petrolatum (pet.) appears to be appropriate. The importance of AEPD and MDEA as MWF allergens still remains to be established. The lack of positive test reactions to the other MWF components tested may be due to their low-sensitizing potential or too low a patch test concentration being used.