3,3'-methylenebis[5-methyloxazolidine]

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 January 1990 to 31 December 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well performed study under good scientific standards

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1998

Report date:

1997

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Grotan OD, Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)

IUPAC Name:

Grotan OD, Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)

Details on test material:

- Name of test material (as cited in study report): Grotan OD
- Chemical name: Methylene-bis-(methyloxazolidine)
- Substance type: Formaldehyde releaser
- Physical state: Liquid
- Composition of test material, percentage of components: Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)

Method

Type of population:

occupational

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 1787 patients were patch tested in an industrial biocide tray

Occupation (only most frequent)
20% mechanics, toolmakers, engineers
14% metal workers
4% office workers
3% electricians
8% undetermined exposure

- Sex: 76% male patients and 24% female patients
- Age: 55% < 40 years, 45% > 40 years

Clinical history:

- History of allergy or casuistics for study subject or populations: Continously recorded for all patients
- Symptoms, onset and progress of the disease: Atopic dermatitis past or present 21%; allergic rhinoconjunctivitis 11%; allergic bronchial asthma 5%;occupational causes suspected in 46%; Localization of contact dermatitis mostly hands (65%)

- Exposure history: Occupational history and suspected allergen exposure continously recorded

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: Epicutaneous patch tests; patients exposed to the test substance for 24 or 48 h (most patients 48 h); Patch test performed according to recommendations of the International Contact Dermatitis Research Group; in most hospitals investigators used “Finn-chambers-on Scanpor” method (no further details); reaction were scored 72 h after application of chambers. Test item concentartion 1% in PET (Petrolatum).
No further data available.

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
46 out of 1522 tested patients (3.0%) showed an allergic reaction after exposure to the substance “reaction product from paraformaldehyde and 2-hydroxypropylamine (ratio 3:2)”, 19 patient showed a questionable/irritative reaction. The age-adjusted frequency of sensitization in men was 2.3% at <40 years and 4.6% at >40 years.

Applicant's summary and conclusion

Conclusions:

Some evidence for sensitizing activity in humans. Numerous industrial biocides were tested in this study. The substance has been shown to be one of the most sensitizing substances.

Executive summary:

The available data give some information about the sensitizing potential of the test substance after occupational use.. Epicutaneous patch tests: patients exposed to the test substance for 24 or 48 h (most patients 48 h); reaction were scored 72 h after application of chambers. 1522 patients were tested with the test substance.

In a group of 1522 patients tested for contact allergy 46 patients (or 3.0%) showed a positive reaction after exposure to the substance. Similar results were presented by Geier et al., 1997.