Registration Dossier

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: reliable source, basic data on the study were given

Data source

Reference
Reference Type:
publication
Title:
Alkanolamines - Sensitizing capacity, cross reactivity and review patch test reactivity
Author:
Wahlberg Jan., Boman A.
Year:
1996
Bibliographic source:
Dermatosen in Berful und Umwelt. Occupation and environment V 44: pg 222-224

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: 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): monoethanolamine
- Analytical purity: 99.9 %
- Impurities (identity and concentrations): < 0.1% diethanolamine and tetraethanolamine

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sahlins Försöksdjursfarm (Malmö, Sweden)
- Housing: plastic cages

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Induction concentrations: 0.6 % (intradermal) and 10.3% (epicutaneous)
Challenge concentrations: 4.01, 2.05 and 0.41%
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
Induction concentrations: 0.6 % (intradermal) and 10.3% (epicutaneous)
Challenge concentrations: 4.01, 2.05 and 0.41%
No. of animals per dose:
15 animals for the test substance
12 animals for control
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
Dose level:
4.1%
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 4.1%. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.05
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.05. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.41
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.41. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
4.1%
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 4.1%. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
2.05%
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 2.05%. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.41%
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.41%. No with. + reactions: 0.0. Total no. in groups: 12.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU