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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:
weight of evidence
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Alkanolamines - Sensitizing Capacity, Cross Reactivity and Review of Patch Test Reactivity
Author:
Wahlberg, Jan E.; Boman, Anders
Year:
1996
Bibliographic source:
Dermatosen/Occup. Environ. 44, 222-224

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Publication from 1996, when the LLNA was not yet an established method for determination on skin sensitization.

Test material

Reference
Name:
Unnamed
Type:
Constituent

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 Försöksdjursfarms (Malmö, Sweden)
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: groups of three in plastic cages
- Diet: not specified
- Water not specified
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Concentration / amount:
0.6 %
Route:
epicutaneous, occlusive
Vehicle:
other: pre-treatment with 10% SDS
Concentration / amount:
10.3 %
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: exp. 1: water; exp. 2: saline
Concentration / amount:
4.1 %
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: exp. 1: water; exp. 2: saline
Concentration / amount:
2.05 %
No.:
#3
Route:
epicutaneous, occlusive
Vehicle:
other: exp. 1: water; exp. 2: saline
Concentration / amount:
0.41 %
No. of animals per dose:
two epxeriments with 15 animals per dose group
Details on study design:
RANGE FINDING TESTS: The concentrations used for induction and challenge were based on previous experience with Triethanolamine (TEA). And the concentrations of MEA were equimolar to those of TEA.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: not specified
- Control group: Vehicle group
- Site: not specified
- Frequency of applications: not specified

B. CHALLENGE EXPOSURE
- No. of exposures: single exposure
- Day of challenge: after 3 weeks
- Evaluation (hr after challenge): 48 and 72 hours
Challenge controls:
no
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 group
Dose level:
exp 1: 4.1%
No. with + reactions:
2
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
exp. 1: 4.1 %
No. with + reactions:
3
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
exp. 1: 2.05 %
No. with + reactions:
1
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
exp. 1: 2.05 %
No. with + reactions:
2
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
exp. 1: 0.41 %
No. with + reactions:
2
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
exp. 1: 0.41 %
No. with + reactions:
3
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
exp. 2: 4.1 %
No. with + reactions:
1
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
exp. 2: 4.1 %
No. with + reactions:
1
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
exp. 2: 2.05 %
No. with + reactions:
2
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
exp. 2: 2.05 %
No. with + reactions:
1
Total no. in group:
15
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
exp. 2: 0.41 %
No. with + reactions:
0
Total no. in group:
15
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
exp. 2: 0.41 %
No. with + reactions:
0
Total no. in group:
15

Any other information on results incl. tables

Table 1. Induction with Monoethanolamine according to the GPMT, Challenge with the same substance or tri- or diethanolamine in water or saline at 3 different concentrations and vehicle controls. The number of animals with positive reaction is given.

Induction

Time (h)

Challenge concentration (%)

 

 

Triethanolamine (TEA)

Diethanolamine (DEA)

Monoethanolamine (MEA)

Vehicle control

 

 

10

5

1

7

3.5

0.7

4.1

2.05

0.41

Water

Saline

Exp 1: MEA; n=15

48

2

2

NT

2

0

NT

2

1

2

2

NT

72

2

3

NT

2

0

NT

3

2

3

2

NT

Exp. 2 MEA; n=15

48

1

0

NT

2

0

NT

1

2

0

NT

0

72

0

0

NT

1

0

NT

1

1

0

NT

0

Exp. 1 Control; n=12

48

0

0

0

0

0

0

0

0

0

0

NT

72

0

0

0

0

0

0

0

0

0

0

NT

Exp. 2 Control; n=12

48

0

0

NT

0

0

NT

0

0

0

NT

1

72

0

0

NT

0

0

NT

0

0

0

NT

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met