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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported study performed under GLP and using a standard test method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
EC Number:
278-928-2
EC Name:
1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
Cas Number:
78491-02-8
Molecular formula:
C8H14N4O7
IUPAC Name:
1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Males, bodyweight 2.2-2.6 kg pre-test.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
0.2 ml distilled water used to moisten the gauze patch
Controls:
not required
Amount / concentration applied:
0.5g/rabbit applied to skin, covered with gauze, plastic torso wrap and tape.
Duration of treatment / exposure:
4h (followed by patch removal and gentle site washing with distilled water).
Observation period:
1, 24, 48, 72h after dressing removal.
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: all animals
Time point:
other: 1, 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
other: all animals
Time point:
other: 1, 24, 48 and 72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin reactions observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance proved non-irritating to rabbit skin.