4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test material

Test material information

Constituent 1

Reference substance name:

4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

EC Number:

223-496-2

EC Name:

4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

Cas Number:

3923-79-3

Molecular formula:

C5H10N2O3

IUPAC Name:

4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

Test material form:

liquid

Details on test material:

Name of the test substance used in the study report: Fixapret NF

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Young adult animals were used. They were identified via ear tattooing. The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20-24°C for temperature and of 30 - 70% for relative humidity. The day/night rhythm was 12 h dark and 12 h light. The animals were housed singly in stainless steel wire mesh carges with grating (floor area: 3000 cm2) with no bedding in the cages (sawdust in the waste trays). A standard diet was used (about 130 g per animal/day) and about 250 ml tap water per animal and per day were available.
Weight of female animals: 3.66 and 3.65 kg
Weight of the male animal: 3.45 kg

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping the dorsal of the trunk of the animal(s)

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

Acclimatization period for at least 1 week. Weight determination before application of the test substance.
The test substance was applied in a single dose to the intact untreated skin, the test patch was secured in position with a semiocclusive dressing. The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1:1). The test patch (2.5 x 2.5 cm) was moistened with a dose of 0.5 ml of the unchanged liquid test substance. Application site: the upper third of the back or flanks.
Readings: 1 h, 24 h, 48 h and 72 h after removal of the patch.
A check was made twice each workday and once on weekends and on public holidays for general observations and for any dead or moribund animals.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Conclusions:

Under the test conditions chosen and considering the described findings, the test substance does not give indication of an irritant property to the skin.