N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

publication

Title:

Occupational dermatoses at a film laboratory.

Author:

Liden, C

Year:

1984

Bibliographic source:

Contact Dermatitis, 10: 77-87.

Materials and methods

Type of sensitisation studied:

skin

Study type:

other: questionnaire and patch test

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The investigation consisted of a questionnaire, clinical examination and interview with all employees who stated that they had had skin disease at some time, and patch testing at the laboratory of all cases of suspected occupational dermatoses, and control tests in hospital of 200 non-exposed eczema patients.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate

EC Number:

247-161-5

EC Name:

N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate

Cas Number:

25646-71-3

Molecular formula:

C12H21N3O2S.3/2H2O4S

IUPAC Name:

bis(N-{2-[(4-amino-3-methylphenyl)(ethyl)amino]ethyl}methanesulfonamide); tris(sulfuric acid)

Method

Type of population:

occupational

Ethical approval:

not applicable

Subjects:

- Number of subjects exposed: 103 subjects responded to the questionnaire; 21-23 subjects had patch tests
- Sex: males and females
- Age: not reported
- Race: not reported
- Demographic information: not reported

Clinical history:

- History of allergy or casuistics for study subject or populations: Of the 114 employees, 45% stated that they had had some type of skin disease at some time. 57%of all 28 employed at the time on work directly exposed to photographic chemicals stated that they had had skin disease at some time

Controls:

200 eczema patients who, as far as was known, had not previously been exposed to the substances; controls exposed to CD-2, Kodak; Metol; CD-3, Kodak; and hydroquinone
13 controls for PBA-1, Kodak; HA-2, Kodak; FA-I, Kodak; anti-calcium no. 4, Kodak; phenidone; and RA-1, Kodak

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test

ADMINISTRATION
- Type of application: not reported
- Description of patch: not reported
- Concentrations: The test substances from the standard series were from Trolab (Denmark) and the film chemicals were prepared by the pharmacy of Karolinska Sjukhuset, Stockholm, from bulk mix chemicals from the film laboratory. Finn-Chamber® (Epitest, Finland) was used for the petrolatum dilutions, Al-test® (Imeco, Sweden) for the liquid dilutions; Scanpor® surgical tape (Norgeplaster, Norway) was used.
- Volume applied: not reported
- Testing/scoring schedule: Reading were made 72 h after application, and 2-3 weeks later
- Removal of test substance: Patches were removed after 48 h

EXAMINATIONS
- Grading/Scoring system: not reported
- Statistical analysis: not reported

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 4/23 showed a positive response to CD-3, whereas 0/200 control patch tests showed a positive response

Applicant's summary and conclusion

Conclusions:

Contact allergy to the photographic chemical CD-3 was diagnosed in four cases, showing its sensitizing property. The color developing agent may also give rise to lichenoid reactions and 2 such cases were seen in this investigation.