1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Adequately reported study using a standard test method and a relatively large number of human volunteers.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Type of sensitisation studied:

skin

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Human repeat insult patch test (9 RIPT method)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea

EC Number:

278-928-2

EC Name:

1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea

Cas Number:

78491-02-8

Molecular formula:

C8H14N4O7

IUPAC Name:

1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Method

Type of population:

general

Ethical approval:

not applicable

Remarks:

Informed consent obtained (review board review not required)

Subjects:

19 males, 90 females aged 18 to 68 years showing no physical or dermatological condition which would preclude testing were enrolled in testing. 12 discontinued participation for reasons unrelated to the study, leaving 97.

Clinical history:

No data

Controls:

Distilled, deionised water vehicle control included.

Route of administration:

dermal

Details on study design:

Induction phase:
- test sites cleaned with 70% isopropyl alcohol and allowed to dry
- 9 drops (approximately 0.3 ml) of an aqueous 0.5% solution of test substance applied to 2cm square occlusive patches
- one patch applied to each test subject (adjacent to spinal line of the upper back)
- subjects told to remove patches after 24h
- test sites inspected after 24 or 48h rest period (according to day of patch application), immediately prior to re-patching
- a total of 9 patches applied/subject.

Challenge phase:
- 12-18 days after last induction treatment, test sites inspected and challenge patches applied to virgin test sites
- challenge sites inspected after 24, 48 and 72h.

Rechallenge for one subject:
- 1 subject showing reactions at challenge was rechallenged 8 weeks later.

Solvent controls:
- patched as for test solution, but using deionised distilled water.

Results and discussion

Results of examinations:

Solvent control sites:
scattered, transient minimal to mild responses seen in 3/97 subjects.

Test solution induction:
- one subject (no. 29) showed mild or moderate reaction after 5 of the 9 induction treatments
- no other reactions were seen.

Test solution challenge:
- subject 29 showed faint erythema at the 48h reading, becoming mild at 72h. This had reduced to a faint response after 144h
- no other reactions were seen.

Any other information on results incl. tables

Rechallenge of subject 29 produced no skin reactions. It was concluded that the earlier responses of this subject reflected a cumulative irritation reaction rather than a sensitisation response.

Applicant's summary and conclusion

Conclusions:

In this study, 1/97 human volunteers showed a cumulative irritation response (maximally moderate erythema) to repeated dermal application of a 0.5% solution of test substance. No evidence of sensitisation was seen.