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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline compliant but not GLP compliant study but nevertheless well documented and scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 1981
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-divinylimidazolidin-2-one
EC Number:
237-457-2
EC Name:
1,3-divinylimidazolidin-2-one
Cas Number:
13811-50-2
Molecular formula:
C7H10N2O
IUPAC Name:
1,3-diethenylimidazolidin-2-one
Details on test material:
Name of the test substance used in the study report: Divinylethylenharnstoff

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, Germany
- Weight at study initiation: males 2.99 kg, female 2.34 kg
- Housing: One animal per cage (type: stainless steel with wire mesh walk floors, floor area 40 x 51 cm); they were identified via ear tattoo.
- Diet: standardized animal laboratory diet (about 130 g/animal/day)
- Water: tap water (about 250 mL/animal/day)
- Acclimation period: at least 8 days before study start

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%.
- Air changes: fully air-conditioned rooms
- Photoperiod: 12 h light and 12 h dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
The test patches (2.5 x 2.5 cm) were covered with 0.5 g of the test substance and has been moistened with aqua dest.
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
Clipping of the fur: at least 15 hours before study start
Application area: 2.5 x 2.5 cm
Application site: upper third of the back or flanks
Removal of the test substance: at the end of the exposure period with Lutrol and Lutrol/water (1:1)
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h and 72 h after beginning of application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
female
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
female
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
male
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information