2-(hydroxymethylamino)ethanol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer revieved journal.

Data source

Reference

Reference Type:

review article or handbook

Title:

Dermatitis in paperhangers

Author:

SHIRO TANAKA AND JAMES B. LUCAS

Year:

1984

Bibliographic source:

Contact Dermatitis, Volume 10, Issue 1, page 54, January 1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

2-[hydroxy(methyl)amino]ethanol /(34375-28-5) was evaluated for its skin sensitizing potential.Skin sensitisation test performed on human by using patch test.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

Not specified .

Test material

Test material information

Constituent 1

Reference substance name:

2-(hydroxymethylamino)ethanol

EC Number:

251-974-0

EC Name:

2-(hydroxymethylamino)ethanol

Cas Number:

34375-28-5

Molecular formula:

C3H9NO2

IUPAC Name:

2-[hydroxy(methyl)amino]ethanol

Details on test material:

- Name of test material: Ethanol, 2-(hydroxymethylamino)
- Molecular formula: C3-H9-N-O2
- Molecular weight: 91.1091 g/mole
- Substance type: Organic

Specific details on test material used for the study:

Name of test material (as cited in study report): 2[(hydroxymethyl)amino]ethanol
Molecular formula (if other than submission substance): C3H9NO2
Molecular weight (if other than submission substance): 91.1091
Substance type: Organic
Physical state: Liquid

In vivo test system

Test animals

Species:

human

Strain:

other:

Remarks:

Not applicable.

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
Source: members of the paperhanger's union in New York City.
Age at study initiation: ages from 31 to 59; median49 years old
Weight at study initiation: Not mentioned
Housing: Not mentioned
Diet (e.g. ad libitum): Not mentioned
Water (e.g. ad libitum): Not mentioned
Acclimation period: Not mentioned

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

5% aqueous solution

Challenge

Route:

other: Not performed

Vehicle:

water

Concentration / amount:

5% aqueous solution

No. of animals per dose:

11 male humans

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
No. of exposures: Single
Exposure period: 72 hours
Test groups: 11 volunteers
Control group: 6
Site: hands
Frequency of applications:
Duration:72 hours
Concentrations: 5%

B. CHALLENGE EXPOSURE
No. of exposures: Not mentioned
Day(s) of challenge: Not mentioned
Exposure period: Not mentioned
Test groups: 11
Control group: 6
Site: Not mentioned
Concentrations: 5 %
Evaluation (hr after challenge): 48 and 72 hour

OTHER:
Full-time paperhangers have continuous exposure to the paste and its chemical additives which may cause allergic contact dermatitis. The manufacturer of pastes used by these paperhangers reported that the paste was made of water, starch, refined clay, vinyl acetate and chemical additives like chloromethoxy propyl mercuric acetate, 2-[(hydroxymethyl)amino ]ethanol and polyethylene glycol monolauroyl ester.

Challenge controls:

Pretested on 6 control

Positive control substance(s):

not specified

Study design: in vivo (LLNA)

Statistics:

No data available.

Results and discussion

Positive control results:

When pretested on 6 control subjects, these patch test solutions produced negative reactions

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

72

Group:

test chemical

Dose level:

5% aqueous solution (v/v) of the test chemical

No. with + reactions:

11

Total no. in group:

11

Clinical observations:

Not mentioned

Remarks on result:

positive indication of skin sensitisation

Any other information on results incl. tables

When pretested on 6 control subjects, these patch test solutions produced negative reactions.

Patch test results for 2-[(hydroxymethyl)amino ]ethanol

Chemical name	Test solution	Patients results (72 h)
2-[(hydroxymethyl)amino ]ethanol	5%	1	2	3	4	5	6-11
		-	+++	++	+++	+++	-

Applicant's summary and conclusion

Interpretation of results:

other: sensitising

Conclusions:

2[(hydroxymethyl)amino]ethanol was observed for its skin sensitizing potential in human by patch test.In this limited series of patch testing, 2-[(hydroxymethyl) amino ] ethanol was the most allergenic to the patients after 72 hours observations.

Executive summary:

Skin sensitization test for 2[(hydroxymethyl)amino]ethanol (34375-28-5) was assessed for its possible contact allergenic potential .For this purpose11 paperhangers (ages from 31 to 59; median 49 years old) were patch tested for the additives, 2-[(hydroxymethyl)amino ]ethanol and polyethylene glycol monolauroyl ester.

They were observed for skin reactions after 48 and 72hours. The test material was patch tested at concentration of 5%.When pretested on 6 control subjects, these patch test

solutions produced negative reactions. 2-[(hydroxymethyl) amino ] ethanol was the most allergenic to the patients after 72 hours observation

It can be concluded that2[(hydroxymethyl)amino]ethanol (34375-28-5)is a strong skin sensitizer in human .