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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Data were obtained from a reliable secondary source (MAK. 33rd update, 2001).

Data source

Reference
Reference Type:
publication
Title:
Alkanolamines - sensitizing capacity, cross reactivity and review of patch test reactivity.
Author:
Wahlberg JE and Boman A
Year:
1996
Bibliographic source:
Dermatosen Beruf Umwelt 44: 222-224

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Guinea pig maximisation test
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-aminoethanol
- Analytical purity: not specified
- Impurities (identity and concentrations): < 0.1 % di- and triethanolamine
- no further data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
Albino guinea pigs of the Dunkin-Hartley strain were obtained from SahIins Försöksdjursfarm Malmö, Sweden) and kept in groups of three in plastic cages.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
0.6 % (intradermal) and 10.3 % (epicutaneous) for induction
0.41, 2.05 and 4.1 % for challenge
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
0.6 % (intradermal) and 10.3 % (epicutaneous) for induction
0.41, 2.05 and 4.1 % for challenge
No. of animals per dose:
15 animals used for the test substance (5 animals per concentration)
12 animals used for controls
Details on study design:
The GPMT protocol with the same experimental design as in a previous study on TEA (Boman et al., 1993) was followed. Groups of 15 animals were induced with either MEA, DEA or TEA and then challenged after three weeks with the inducing amine and the two others. Prior to the topical induction, pretreatment with 10% sodium dodecyl sulphate was carried out. The concentrations used for induction and challenge were based on previous experience with TEA and the concentrations of MEA and DEA were equimolar to those of TEA. The challenge reactions were read blindly 48 and 72 h after application or the patches (Finn chambers). Two separate experiments were carried out with MEA. Control groups of twelve animals were given the same treatment (Freund's Complete Adjuvant, vehicle, occlusion, etc.) except for the inducing amine.
Challenge controls:
no data
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
4.1%
No. with + reactions:
2
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 4.1%. No with. + reactions: 2.0. Total no. in groups: 15.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
2.05%
No. with + reactions:
1
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.05%. No with. + reactions: 1.0. Total no. in groups: 15.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0.41%
No. with + reactions:
2
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.41%. No with. + reactions: 2.0. Total no. in groups: 15.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
4.1 %
No. with + reactions:
3
Total no. in group:
15
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 4.1 %. No with. + reactions: 3.0. Total no. in groups: 15.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
2.05 %
No. with + reactions:
2
Total no. in group:
15
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 2.05 %. No with. + reactions: 2.0. Total no. in groups: 15.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
0.41 %
No. with + reactions:
3
Total no. in group:
15
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.41 %. No with. + reactions: 3.0. Total no. in groups: 15.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
1st reading
Hours after challenge:
72
Group:
other: vehicle control
No. with + reactions:
2
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group:
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
4.1%
No. with + reactions:
1
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 4.1%. No with. + reactions: 1.0. Total no. in groups: 15.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
2.05%
No. with + reactions:
2
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.05%. No with. + reactions: 2.0. Total no. in groups: 15.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0.41%
No. with + reactions:
1
Total no. in group:
15
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.41%. No with. + reactions: 1.0. Total no. in groups: 15.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
4.1%
No. with + reactions:
1
Total no. in group:
15
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 4.1%. No with. + reactions: 1.0. Total no. in groups: 15.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
2.05%
No. with + reactions:
1
Total no. in group:
15
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 2.05%. No with. + reactions: 1.0. Total no. in groups: 15.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
0.41%
No. with + reactions:
0
Total no. in group:
15
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.41%. No with. + reactions: 0.0. Total no. in groups: 15.0.

Any other information on results incl. tables

After challenge with 4.1 %, 2.05 % and 0.41 % of 2-aminoethanol, 3/15, 2/15 and 3/15 animals reacted positively after 72 hours. Two out of 15 animals showed a reaction to the vehicle. Of the 12 control animals, none reacted to 2-aminoethanol or the vehicle. Possible cross reactions to 5 % of triethanolamine and 7 % of diethanolamine occurred in 3 and 2 animals, respectively. In a 2nd test, only 1 or 2 animals showed a reaction to 4.1 % and 2.05 % of 2-aminoethanol, but none of the animals reacted to 0.41 % of 2-aminoethanol or the physiological saline solution used as a vehicle in this study. Moreover, reactions to 10 % of triethanolamine and 7 % of diethanolamine were only observed in 1 and 2 animals, respectively. Of the 12 control animals none reacted to one of the ethanolamines, and 1/12 animals reacted to the vehicle after 24 hours.

The test with monoethanolamine has been performed twice.

Applicant's summary and conclusion