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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: The Official method published in the Official Journal of the Franch Républic dated 26 december 1996
Deviations:
no
Principles of method if other than guideline:
The evaluation of ocular irritant potential of a test item may be carrying out the Het-Cam assy (Hen's egg test Chorio-Allantoic Membrane) as an alternative method to animal experimentation.
The principle is based on the observation of irritant effects (hyperemia, hemorrhage and coagulation) within 5 minutes after the test item application on the chorioallantoic membrane of a 10 days fertilized hen's eggs.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
ethyl 2-cyano-3-oxobutanoate
EC Number:
700-172-3
Cas Number:
634-55-9
Molecular formula:
C7 H9 NO3
IUPAC Name:
ethyl 2-cyano-3-oxobutanoate

Test animals / tissue source

Species:
other: Chorioallantoic membrane of a hen's egg

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 22 seconds
Score:
ca. 9
Reversibility:
not specified
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 8 seconds
Score:
ca. 9
Reversibility:
not specified
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 15 seconds
Score:
ca. 9
Reversibility:
not specified
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: 18 seconds
Score:
ca. 9
Reversibility:
not specified
Irritant / corrosive response data:
The Irritation Score (IS) was equal to 9 with the test item at 100 %.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: JORF dated 26 december 1996
Conclusions:
The est item was applied pure on the chorioallantoic membrane of 4 white leghorn fertilized eggs at the dose of 0.3 mL. The experimental protocol was established under the Official method published in the Official Journal of the French Republic dated 26 december 1996.

Hyperemia, hemorrhage ans coagulation were recorded during 5 minutes. The Irritation µScore (IS) of the test item is the average arithmetic of the scores obtained on 4 eggs.

The Irritation score (IS) was equal to 9 with the test item at 100 %.

In conclusion, the results obtained under these experimental conditions, enable to conclude that the test item must be classified "Irritant" according to the classification established in the JORF dated 26 decembre 1996.