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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
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

Resultsopen allclose all
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:
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 #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 #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 #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 #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.