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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
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
Justification for non-LLNA method:
The guinea pig test method described in OECD TG 406 provide suitable information for hazard identification.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-methyliminodiethanol
EC Number:
203-312-7
EC Name:
2,2'-methyliminodiethanol
Cas Number:
105-59-9
Molecular formula:
C5H13NO2
IUPAC Name:
2-[(2-hydroxyethyl)(methyl)amino]ethan-1-ol

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
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 %
No. with + reactions:
10
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
10
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
18
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20

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:
GHS criteria not met