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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited documentation, substance tested only as 50% dilution, observation/reading only at 24 hours and 8 days, only 2 animals tested

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 as 50% dilution for 20 hours under occlusive conditions. Observation/reading only at 24 hours and 8 days, only 2 animals tested
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N''-(isobutylidene)diurea
EC Number:
228-055-8
EC Name:
N,N''-(isobutylidene)diurea
Cas Number:
6104-30-9
Molecular formula:
C6H14N4O2
IUPAC Name:
N,N''-(2-methylpropane-1,1-diyl)diurea
Details on test material:
purity ca. 90-96% (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: ca. 2.8 kg
- sex: male

no further data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
Substance applied as a 50 % aqueous preparation (ca. 0.5 g on an area of about 2 .5 cm x 2.5 cm); occlusive application
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:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks on result:
other: 24 hours and 8 days were selected as reading time points
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks on result:
other: 24 hours and 8 days were selected as reading time points
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks on result:
other: 24 hours and 8 days were selected as reading time points
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks on result:
other: 24 hours and 8 days were selected as reading time points

Any other information on results incl. tables

- 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 hrs to rabbit skin did not lead to any signs of irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Occlusive application for 20 hrs to rabbit skin did not lead to any signs of irritation at any time during the 8 days of observation.