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Administrative data

Description of key information

MDEA is not a skin sensitiser in animals as tested in a Maximisation test with guinea pigs (similar to OECD guideline 406).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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.
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


Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Intradermal induction: 5 %
Epicutaneous induction: 100 %
Challenge: 100 %
Rechallenge: 50 %, 10%
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
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

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.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The sensitising potential of MDEA was investigated in a Maximisation test according to the method of Magnusson and Kligman (similar to OECD 406) in guinea pigs (10/sex) (Leung et al, 1988). The test material was administered at 5% (in propylene glycol), for the intradermal induction, and at 100%, for the topical induction, to 20 Dunkin Hartley guinea pigs (10/sex). Fourteen days after the last induction exposure, the challenge treatment was administered topically at 100%. Dermal evaluations were made approximately 24 and 48 hours after the removal of challenge/re-challenge (see below) patches. 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% MDEA exhibited clear dermal responses. However, all ten irritation control animals also exhibited clear dermal responses. As the results at the challenge were equivocal, a re-challenge was performed in the same manner as the challenge, but at concentrations of 50% and 10% MDEA. In order to differentiate dermal reactions produced by irritation from those produced by sensitisation, 20 animals (5/sex/challenge; treated concurrently during induction with only vehicle or FCA/water emulsion) were subjected to the same challenge or re-challenge procedures as the animals which received test material during the induction exposures. All test group animals re-challenged with 50% and 10% MDEA 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, MDEA produced sporadic irritation, but did not produce dermal sensitisation in guinea pigs.



Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No 1272/2008. Based on these information the test item is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.