1-(2-hydroxyethyl)imidazolidin-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, available as unpublished report, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-hydroxyethyl)imidazolidin-2-one

EC Number:

223-032-9

EC Name:

1-(2-hydroxyethyl)imidazolidin-2-one

Cas Number:

3699-54-5

Molecular formula:

C5H10N2O2

IUPAC Name:

1-(2-hydroxyethyl)imidazolidin-2-one

Details on test material:

- Name of test material: Hydroxyethylethylene urea
- CAS No.: 3699-54-5
- Appearance: white, solid, crystalline melt
- Purity: > 98%
- Impurities: urea < 1%, water < 1%

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Savo: Med. Versuchstierzuchten GmbH, D-79664 Kisslegg/Allgaeu, FRK
- Weight at study initiation: 2.57-2.83 kg
- Housing: Cages made of stainless steel with mesh walk floors. Floor area: 40 cm x 51 cm. No. of animals per cage: 1
- Diet: Kliba 341, 4 mm; Frima Klingentralmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study; same housing condintions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

Application of 0.5 ml of the undiluted test substance to the test patch (2.5 cm x 2.5 cm)

Duration of treatment / exposure:

4 hours

Observation period:

The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the test substance.

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: upper third of the back or flanks
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Evaluation of erythema (R) and Edema (ED)
0= none
1=very slight
2=well-defined
3=moderate to severe
4=severe to very severe

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

One hour after removal of the substance, very slight erythema (score 1) was observed in all animals, which was no longer visible in two animals at 24 hours after exposure and in one animal 48 hours after exposure.