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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.