Registration Dossier

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
Justification for type of information:
2018 study following guidelines and performed to GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Named in some reports as 2-propenenitrile, polymer with 1,2-ethanediamine
Dried material, described as viscous liquid, is used for some tests.
Specific details on test material used for the study:
Water-free material
Purity: 92.5%
Physical state/Appearance: Greenish-yellow viscous liquid

Test animals / tissue source

Species:
cattle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
0.75 ml undiluted added to the chamber with the cornea
Duration of treatment / exposure:
Incubated at 32 ± 1 ºC for 10 minutes
Duration of post- treatment incubation (in vitro):
120 minutes
Number of animals or in vitro replicates:
Three replicates for test material and controls

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
1
Value:
ca. 2
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

The positive control In Vitro Irritancy Score was within the range of 31.6 to 58.7.

The negative control gave opacity of ≤3.0 and permeability ≤0.077.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Although the study design is more suitable for the Eye Dam 1 and Eye Irrit 2 boundary, the method is validated to accept very low scores as being non-classified for CLP.
The method was chosen as the substance was considered likely to be Eye Irrit 2 based on free amine and reported pH.
The irritation scroe of 2.0 is sufficiently low to conclude non-classification for CLP