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

Endpoint summary

Description of key information

In an in vivo study according to OECD guideline 404, the undiluted test substance was applicated for 4 hours under semiocclusive conditions to the skin of New Zealand White rabbits. Results did not give indication of an irritant property to the skin under the test conditions chosen and considering the described findings.

In a supporting in vivo rabbit study, the test item was not irritating to to skin after 24-hour occlusive treatment to intact skin.

 

In a key eye irritation study according to OECD 405, the test substance was injected into the eyes of New Zealand White rabbits. Results did not give indication of an irritant property after 24 hours of treatment.

In a supporting in vivo eye irritation study in rabbits, the test substance was not irritating to the eyes after injection and 24-hour treatment.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

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

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.

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

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

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Key, in vivo skin irritation, RL2

BASF (1995) reported about the acute dermal irritation/corrosion of 4,5-Dihydroxy-1,3-dimethylimidazolidin-2-one. New Zealand White rabbits were applicated 0.5 mL of the undiluted test substance for 4 hours under semiocclusive conditions. Under the test conditions of this study, the test substance does not give an indication of an irritant property to the skin.

 

Supporting, in vivo skin irritation, RL2

Hill Top (1979) reported a skin irritation study with Textile Resin NFU (= 4,5-Dihydroxy-1,3-dimethylimidazolidin-2-one). New Zealand White rabbits were applicated (intact and abraded skin) 50 mL of the indiluted test substance for 24 hours under occlusive conditions. No skin reactions were found.

 

Key, in vivo eye irritation, RL2

BASF (1995) reported an acute eye irritation study. 0.1 mL of the unchanged test substance were injected into the eyes of New Zealand White rabbits. Duration of treatment was 24 hours. Under the test conditions of this experiment, the test substance does not give an indication of an irritant property.

 

Supporting, in vivo eye irritation, RL2

The Springborn Institute (1980) tested 4,5 -Dihydroxy-1,3-dimethylimidazolidin-2-one concerning eye irritation. 0.1 mL of the undiluted test substance were injected into the eyes of New Zealand White rabbits. Duration of treatment was 24 hours. The test material was considered as non-irritant.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data, the test item is not classified and labelled for skin irritation according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.