N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Brief report of a study using a standard HRIPT method with a large volunteer panel, containing sufficient information to form reliable conclusions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Human repeat insult patch test with 200 volunteers.

GLP compliance:

no

Remarks:

Pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]

EC Number:

254-372-6

EC Name:

N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]

Cas Number:

39236-46-9

Molecular formula:

C11H16N8O8

IUPAC Name:

N',N'''-methylenebis{1-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea}

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

White powder

Method

Type of population:

general

Ethical approval:

other: informed consent contract signed

Subjects:

200 individuals selected from local population.

Clinical history:

Absence of skin disease capable of confusing skin reactions was confirmed.

Controls:

Not required

Route of administration:

dermal

Details on study design:

Discs moistened with an aqueous 10% solution of test substance placed on upper arm sites and covered with occlusive tape. Dressings removed after 24h, test sites scored for reaction. Unless reaction seen, test applications repeated at the same site 24-48h later. A total of 15 applications made in this way (Monday - Wednesday - Friday each week for 5 consecutive weeks).
After a 2-week rest period, each volunteer was challenged using the same dermal patch procedure, and skin reactions were scored on patch removal plus 24 a d 48h later.

Results and discussion

Results of examinations:

No visible skin reactions were observed in any of the 200 volunteers tested, either following any of the 15 induction treatments or after challenge.

Any other information on results incl. tables

Based on the complete absence of effect in 200 volunteers, the report predicts with 95% certainty that 98.17% of a general human population will not be sensitised by repeated skin application of the test substance.