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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: GLP study according to EU/OECD-guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium 4-(methoxycarbonyl)-5-oxo-2,5-dihydrofuran-3-olate
EC Number:
627-063-2
Cas Number:
1134960-41-0
Molecular formula:
C6H5O5Na
IUPAC Name:
sodium 4-(methoxycarbonyl)-5-oxo-2,5-dihydrofuran-3-olate

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h-72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h-72h
Score:
0
Max. score:
0
Other effects:
As no clinical signs and no skin irritation effects were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation.
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is non-irritant to the skin according to the Draize classification system.
The study result triggers the following classification/labelling:
- EU Directive 1999/45/EC (as amended): none
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 4) 2011: none