Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
skin and eye irritation tests performed on the same individual
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
skin and eye irritation tests performed on the same individual
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
(2,4-dioxo-1,3-benzoxazin-7-yl) ethyl carbonate
EC Number:
605-404-6
Cas Number:
16535-55-0
Molecular formula:
C11 H9 N O6
IUPAC Name:
(2,4-dioxo-1,3-benzoxazin-7-yl) ethyl carbonate

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
1
Details on study design:
A sample of 0.5 gram of V194024 was applied to the intact skin of a shave area on a flank of an albino rabbit (New Zealand White, SPF-quality). The patch was fixed with a dressing, which was wrapped around the abdomen and secured with an elastic bandage. The application should be regarded as a semi-occlusive application. Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened withtap water and subsequently a dry tissue.

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:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A skin irritation test (OECD 404) was performed with V194024. No indication of skin irritation was found and the substance can therefore be considered as non-irritant to the skin.