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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study predates the OECD test guidelines and GLP. However, the study meets basic scientific principles with acceptable restrictions when compared to current standards (limited documentation, substance tested only as 50% dilution, observation/reading only at 24 hours and 8 days, only 2 animals tested). The study is a read-across from a structural analogue substance (CAS 6104-30-9).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report date:
1967

Materials and methods

Principles of method if other than guideline:
The test substance was applied substance as 50% dilution for 20 hours under occlusive conditions. Observation/reading was performed only at 24 hours and 8 days and only 2 animals were tested.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
N,N''-(isobutylidene)diurea
EC Number:
228-055-8
EC Name:
N,N''-(isobutylidene)diurea
Cas Number:
6104-30-9
IUPAC Name:
N,N''-(2-methylpropane-1,1-diyl)diurea
Test material form:
other: aqueous preparation
Details on test material:
- Analytical purity: ca. 90-96%
- Impurities (identity and concentrations): 0-3% urea, 2% potassium sulfate

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: approximately 2.8 kg
- sex: male

No further data are given in the study report.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g
- Concentration (if solution): 50% aqueous preparation
Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over both tested animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: No signs of irritation were observed.
Irritation parameter:
edema score
Basis:
mean
Remarks:
over both animals
Time point:
other: mean over 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: Nno signs of irritation were observed.
Other effects:
- Systemic toxicity: No mortality occurred. There were no signs of clinical toxicity from the dermal exposure.
- Irritation score: No skin findings were observed at any time
- Summary: Occlusive application for 20 h to rabbit skin did not lead to any signs of irritation at any time during the 8 days of observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified