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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
The study was performed in compliance with the following regulations or guidelines:
 OECD Guideline for the Testing of Chemicals No. 437 (updated 26 July 2013)
“Bovine Corneal Opacity and Permeability Assay”
 Method B.47 of Commission Regulation (EC) No. 440/2008
Deviations:
yes
Remarks:
When performing the optical density measurements it was obvious from the coloration of the wells that dilutions needed to be formed on the positive controls, so one run was performed to include dilutions. However this is a deviation to the study plan but
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-triene-7-carbonitrile
EC Number:
609-091-7
Cas Number:
35202-54-1
Molecular formula:
C11H11NO2
IUPAC Name:
3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-triene-7-carbonitrile

Test animals / tissue source

Species:
cattle

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. 0.5
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No category. Not requiring classification to UN GHS or EU CLP.