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: Acceptable, well documented publication which meets basic scientific principles.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The Skin Sensitization Potential of Four Alkylalkanolamines
Author:
Leung HW et al.
Year:
1998
Bibliographic source:
Vet Human Toxicol 40 (2), 65-67
Reference Type:
secondary source
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Sensitisation study according to Magnuson and Kligmann
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): N-methyldiethanolamine, MDEA

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: male: 340 - 458 g; female: 312 - 439 g


Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Intradermal induction: 5 %
Epicutaneous induction: 100 %
Challenge: 100 %
Rechallenge: 50 %, 10%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Intradermal induction: 5 %
Epicutaneous induction: 100 %
Challenge: 100 %
Rechallenge: 50 %, 10%
No. of animals per dose:
Test group: 10/sex
Positive control: 5/sex
Irritation control: 5/sex
Challenge controls:
Irritation control animals 5 male and 5 female guinea pigs, received the same challenge procedures as in the definitive sensitization study, but were treated with only the vehicle and/or FCA/water emulsion during the intradermal and/or epicutaneous induction procedures. This allowed differentiation between primary skin irritation due to the test material and that produced by a hypersensitivity reaction.
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitrobenzene

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 %
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
18
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 18.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

All 10 animals challenged with 0.1% of the positive control DNCB showed clear skin response while all the irritation control animals were free of skin response. Eighteen of the 20 animals challenged with 100% N-methyldiethanolamine exhibited clear dermal responses. However, all ten irritation control animals exhibited clear dermal responses.

 

Due to the responses seen in the irritation controls, a Re-Challenge was performed at lower, less irritating concentrations. Animals were re-challenged with both 50% and 10% N-methyldiethanolamine at separate sites. All test group animals re-challenged with 50% and 10% N-methyldiethanolamine were free of dermal responses. In addition, all irritation control animals were free of dermal responses, confirming that non-irritating concentrations were administered.

 

Under conditions of this study, N-methyldiethanolamine produced sporadic irritation, but did not produce dermal sensitization in guinea pigs.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information