Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Intracutaneous in-vivo test with Guinea pigs was performed before the LLNA was set as preferred test method.

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylaminoethanol
EC Number:
203-710-0
EC Name:
2-methylaminoethanol
Cas Number:
109-83-1
Molecular formula:
C3H9NO
IUPAC Name:
2-(methylamino)ethan-1-ol
Details on test material:
Samples were obtained from the Union Carbide Corporation, Sourth Charlston, WV.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Animals of weight range 340-458 g (males) and 312-439 g(females)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Saline (0.9 %) or ethanol (70 %)
Concentration / amount:
the test substance was used undiluted
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Saline (0.9%) or ethanol (70%)
Concentration / amount:
the test substance was used undiluted
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS:
Range findings study was conducted to select appropriate concentrations for the intradermal and epicutaneous procedures. At 24 and 48 h after dosing, the intradermal sites were evaluated for severity of tissue damage, and the epicutaneous sites were graded for irritation. The concentration which produced only local tissue damage (i.e. no extensive ulceration) was used for the intradermal induction. The highest concentration that produced only mild irritation was considered appropriate for the epicutaneous induction, and the highest concentration which did not produce irritation was used for the epicutaneous challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (1 intradermal and 1 epicutaneous)
- Exposure period: 48 hours in case of epicutaneous induction
- Test groups: 0.1 mL intradermal injections:
1. 50% (v/v) Freund's Complete Adjuvant (FCA) wate emulsion
2. The test material in propylene glycol
3. The test material in FCA/water.
- Duration: epicutaneous induction was performed 7 days after the intradermal induction: The test material (undiluted, or diluted with 0.9% saline or 70% ethanol) was applied to saturation (0.2 mL) to a 2x4 cm filter paper, which was then placed on thetest side and secured with tape.

- Site: 2 sites each of clipped shoulder skin:

- Concentrations: 5% in propylene glycol for the intradermal induction and 25% for the epicutaneous induction

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after epicutaneous induction (21 day from initiation of the study).
- Exposure period: 24 hours
- Test groups: 10 males and 10 females
- Control group:5 males and 5 females received the same challenge proceduresas in the definitive sensitization study, but were treated with only the vehicle and/or FCA/water emulsion during the intradermal and/or epicutaneous induction proc edures. This allows differentiation between primary skin irritation due to the test material and that produced by a hypersensitivity reaction.
- Site: previously untreated site (right flank) by applying 2x2 cm filter paper squares soaked in the appropriate concentration of the test material
- Concentrations: 5% in propylene glycol
- Evaluation (hr after challenge): 24 and 48

OTHER:
Challenge controls:
5 males and 5 females 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 allows differentiation between primary skin irritation due to the test material and that produced by a hypersensitivity reaction.
Positive control substance(s):
not required

Results and discussion

Positive control results:
No skin response

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% in propylene glycol
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
slight, well-defined erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in propylene glycol. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: slight, well-defined erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% in propylene glycol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% in propylene glycol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
Reading:
1st reading
Hours after challenge:
24
Group:
other: challenge control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: No skin response occured in the irritation control animals treated at the same concentration
Remarks:
.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: challenge control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: No skin response occured in the irritation control animals treated at the same concentration
Remarks:
.
Group:
negative control
Remarks on result:
not measured/tested
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
according to the authors
Conclusions:
As postulated by the authors, N-methylethanolamine showed potential to induce allergic contact dermatitis.
Executive summary:

The skin sensitization potential of N-methylethanolamine (MMEA) was evaluated in a guinea pig maximation procedure by the method of Magnusson and Kligman. Eighteen of the 20 animals challenged with a 5% concentration of MMEA were free of skin response, and the 2 remaining animals had clear skin response (scores of 1) at 24 h but not at 48 h following dosing. No skin response occured in the irritation control animals treated at the same concentration.

MMEA is considered to have sensitization potential.