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:
Guideline study performed 2017 to GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Commercial grade containing approximately 45% actives
Specific details on test material used for the study:
Identification: Dodecenyl succinic acid, compound with 2,2',2''-nitrilotriethanol (partially solvent extracted)
Batch: PAH 330/132/1A
CAS Number: 64396-12-9
Purity: ~49.38%
Physical state/Appearance: slightly opaque amber colored viscous liquid

Test animals / tissue source

Species:
cattle
Details on test animals or tissues and environmental conditions:
Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
0.75 mL of the test item or control items were applied to the appropriate corneas.
Duration of treatment / exposure:
The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea.
Each holder was incubated, anterior chamber uppermost, at 32 ± 1 ºC for 10 minutes.
Duration of post- treatment incubation (in vitro):
2 hours

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Run / experiment:
1
Value:
ca. 24.1
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:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The severity of the results was sufficiently low to confirm that the substance was not Eye Dam 1
However, in view of signficant effects, and taking into account the potential irritancy of at least one of the main starting materials / dissociation products, a classification of Eye Irrit 2 is considered valid and no further testing has been performed.