2-imino-1-methylimidazolidin-4-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28.01.2002 - 12.02.2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-imino-1-methylimidazolidin-4-one

EC Number:

200-466-7

EC Name:

2-imino-1-methylimidazolidin-4-one

Cas Number:

60-27-5

Molecular formula:

C4H7N3O

IUPAC Name:

2-imino-1-methylimidazolidin-4-one

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Creatinin
- Physical state: solid
- Expiration date of the lot/batch: 28.01.2004
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Extertal, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 1869, 1818, 1832 g
- Housing: Housed single (male) or with two animals (female) single in steel cages with a plastic bottom mould and a habitat of 5445 square centimeters at the bottom and an overall height of 600 millimeters.
- Diet (e.g. ad libitum): The animals received food "2123" from Altromin International, Lage, Germany as pelleted diet. The food was offered ad libitum.
- Water (e.g. ad libitum): Normal tap water from municipal sources (Stätische Werke Krefeld AG, Abt. 2 TGW, 47804 Krefeld, Germany) was supplied to the animals ad libitum via bottels with rubber stoppers and steel pipes.
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C (17-23 °C)
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 times/hour

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

To ensure that the test substance gets in close contact to the skin 0.5 g of the test substance was moistened with 0.5 mL saline solution.

Duration of treatment / exposure:

The test substance was removed after 4 hours exposure time.

Observation period:

Examination of the treated skin sites was made 1 hour, 4 hours and approximately 24, 48, 72 hours and 7 days after application of the test substance.

Number of animals:

one male and two females

Details on study design:

- 24 hours before dosing a part of the fur on both sides of the dorso-lumbal region of each animal was removed by shearing with an electrical shaving machine exposing an area of skin approximately 10 x 15 cm. Care was taken to avoid abrading the skin and only animals with healthy skin were used in the experiment
- test substance was applied to the front region of both test sites on a gauze pad (3x2 cm) each and held in place by strips of Blenderm (3 M company, St. Paul, USA). The back region behind the gauze was used as control region.

Scoring System:
see "any other information on materials and methods incl. tables"

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Rabbit 501

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

Rabbit 503

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Rabbit 502

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

Rabbit 501

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

Rabbit 503

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

Rabbit 502

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 3 min, 1 h, 4 h, 24 h, 48 h, 72 h and 7 d

Score:

0

Max. score:

8

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema and oedema and no other dermal response were observed at any time point. The numerical scores to the erythema and oedema formations are presented in table 1 under "any other information on results incl. tables"
The Primary Irritation Index was calculated to be "0" scores of maximum "8" possible scores.

Other effects:

Systmemic toxic symptoms caused by the test substance were not observed during the whole study.
Body weight gain was positive and within the normal range.

Any other information on results incl. tables

Table 1: Numerical scores to the erythema and oedema formations.

	Rabbit 1 (Female)							Rabbit 2 (Female)							Rabbit 3 (Male)
	3 min	1 h	4 h	24 h	48 h	72 h	7 d	3 min	1 h	4 h	24 h	48 h	72 h	7 d	3 min	1 h	4 h	24 h	48 h	72 h	7 d
Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the test substance Creatinine was classified as "non-irritant" to skin.

Executive summary:

Creatinine was tested regarding its irritation potential towards the skin according to OECD 404 ("Acute Dermal Irritation/Corrosion"). The potential to cause inflammatory or corrosive changes upon first contact with skin was assessed by occluded application of the test substance for four hours to the shorn skin of two male and one female rabbit, strain New Zealand White. Dermal reactions were assessed 1, 4, 24, 48, 72 hours and 7 days after removal of the test substance.

Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was positive and within normal ranges. No erythema and oedema and no other dermal response were observed at any time point. The Primary Irritation Index was calculated to be "0" from "8" possible scores.

Under the conditions of this study the test substance Creatinine was classified as "non-irritant" to skin.