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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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:
test procedure in accordance with national standard methods with acceptable restrictions

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
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Constituent 1
Chemical structure
Reference substance name:
2-aminoethanol
EC Number:
205-483-3
EC Name:
2-aminoethanol
Cas Number:
141-43-5
Molecular formula:
C2H7NO
IUPAC Name:
2-aminoethanol
Test material form:
liquid

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)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
0.6 % (intradermal) and 10.3 % (epicutaneous)
Challenge
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
0.41, 2.05 and 4.1 %
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 a similar substance (Boman et al., 1993) was followed. Groups of 15 animals were induced with either the test substance, diethanolamine (DEA) or triethanolamine (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 the test substance 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 the test substance. 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
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
4.1%
No. with + reactions:
2
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.05%
No. with + reactions:
1
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.41%
No. with + reactions:
2
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
4.1 %
No. with + reactions:
3
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
2.05 %
No. with + reactions:
2
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.41 %
No. with + reactions:
3
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
-
No. with + reactions:
0
Total no. in group:
12
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
-
No. with + reactions:
0
Total no. in group:
12
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
other: vehicle control
Dose level:
-
No. with + reactions:
2
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
4.1%
No. with + reactions:
1
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.05%
No. with + reactions:
2
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.41%
No. with + reactions:
1
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
4.1%
No. with + reactions:
1
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
2.05%
No. with + reactions:
1
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.41%
No. with + reactions:
0
Total no. in group:
15
Key result
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

After challenge with 4.1 %, 2.05 % and 0.41 % of the test substance, 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 the test substance 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 the test substance, but none of the animals reacted to 0.41 % of the test substance 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.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met