Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 Feb 2017 to 03 May 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (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
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
cattle
Strain:
not specified
Remarks:
bovine cornea

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
100ml of a 10X solution
Duration of treatment / exposure:
single exposure/ one day

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Value:
158
Vehicle controls validity:
valid
Negative controls validity:
valid
Remarks:
Minimal Essential Media
Positive controls validity:
valid
Remarks:
100% Ethanol
Remarks on result:
positive indication of irritation
Remarks:
Severe/corrosive eye irritant
Irritation parameter:
in vitro irritation score
Value:
162.35
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Irritation parameter:
fluorescein leakage
Value:
0.29
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

The positive control, 100 % ethanol, was categorized and received and the negative control, Minimal Essential Material (MEM), was used as a 10% solution in 0.9% saline.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Severe/corrosive eye irritant
Conclusions:
The material was considered a severe/corrosive eye irritant. The material was classified in Category 1.
Executive summary:

To determine the potential for ocular irritation using an alternative to the Draize methodology, a study based on the methodology described in the current OECD Guideline for the Testing of Chemicals No. 437 was conducted. Three bovine corneas per group were dosed with 0.75 ml of Reaction Mass of 4- sulphophthalic acid (CAS 89-08-7) and 3-sulphophthalic acid (CAS 67892-43-7), 3:1 ratio, Minimal Essential Media (MEM, negative control), or 100% ethanol (positive control). Following a 10-minute exposure for each group of dosed corneas, opacity measurements and sodium fluorescein permeability were determined. The MEM solution is then removed from the anterior chamber and replaced with 1.0 ml of 0.4% sodium fluorescein solution. After 90 min the fluid from the posterior chamber is removed and the amount of dye that passed through the cornea is measured as the optical density at 490 nm by a plate reader. For the test substance, the in vitro irritancy score (IVIS) is 162.35, corneal opacity score is 158.00, and the permeability score is 0.290. Based on an IVIS of greater than 55, and as defined in OECD Guideline No. 437, the reaction mass of sulphophthalic acid was determined to be GHS Category 1 and was considered a severe/corrosive eye irritant.