2,4-Imidazolidinedione, 5-(2-methylpropylidene)-, (5Z)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Feb - 24 Jun 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(5Z)-5-(2-methylpropylidene)imidazolidine-2,4-dione

EC Number:

700-726-4

Cas Number:

1369499-44-4

Molecular formula:

C7H10N2O2

IUPAC Name:

(5Z)-5-(2-methylpropylidene)imidazolidine-2,4-dione

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 3.5 - 4.5 months
- Weight at study initiation: 2.6 - 2.9 kg
- Housing: individually
- Diet: ad libitum (ssniff® K-H, ssniff Spezialdiäten GmbH, D-59494 Soest, Germany)
- Water: ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.03.2003 To: 23.03.2003

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: control site on the same animal

Amount / concentration applied:

500 mg/patch and animal

Duration of treatment / exposure:

4 hours

Observation period:

60 min, 24, 48 and 72 hours, continued on a daily basis up to 14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: the test site was covered with a gauze patch; the patch was held in contact with the skin by means of a semi-occlusive dressing (non-irritating tape)

REMOVAL OF TEST SUBSTANCE
- no residual test substance had to be removed

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

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 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 #3

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 #1

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 #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

not determinable

Irritant / corrosive response data:

Under the conditions of the test none of the three rabbits exposed for 4 hours to the test item showed any substance-related changes at the examination time-points 60 minutes, 24, 48 and 72 hours after patch removal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the test material caused no skin irritating/corrosive reactions. The individual mean values for erythema/eschar and edema from gradings at 24, 48 and 72 h were 0 in all three animals.