Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 November 2014 to 10 March 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to GLP and testing guidelines; coherence between data, results and conclusion.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD series on testing and assesment no. 160
Qualifier:
according to guideline
Guideline:
other: Use of an alternate testing framework for classification of eye irritation potential of EPA pesticide products - Office of Pesticide Programs, U.S. Environmental Protection Agency (31 May 2013)
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test item: Disperse Yellow DYLA1306

Test animals / tissue source

Strain:
not specified
Details on test animals or tissues and environmental conditions:
Test system: isolated corneas from the eyes of freshly slaughtered bovine.
Age of animals: 6-12 months

Transport solution: Hanks balanced salt solution (HBSS) Modified supplemented with Penicillin sulphate and Streptomycin sulphate.
Transport conditions: in transport solution at approximately 4°C.

Test system

Vehicle:
physiological saline
Amount / concentration applied:
The test item was spread on each epithelial surface of three idoneous bovine corneas as supplied (150 mg/cornea); 0.75 mL of physiological saline was then added on each cornea in order to better distribute the substance on the cornea surface (final concentration on cornea = 200 mg/mL, approximately 20% w/v)
Number of replicates: 3
Duration of treatment / exposure:
Corneas were exposed in horizontal position for 4 hours ± 10 minutes, incubated in a liquid bath at 32 ± 1°C.
There was no post-exposure period.
Details on study design:
Positive control item: corneas treated 20% (w/v) Imidazole (Sigma, batch no. 0001422794) in physiological saline (0.9% NaCl) (Baxter, batch no. 13D0406).
Negative control item: corneas treated with physiological saline (0.9% NaCl) (Baxter, batch no. 13D0406).
Volume of treatment: 0,75 mL
Number of replicates: 3

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
0.9
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Any other information on results incl. tables

See Final Report.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item Disperse Yellow DYLA 1306 can be classified as “No Category”.
Executive summary:

The potential of the test item, Disperse Yellow DYLA 1306, to cause corrosion/severe irritation by using the Bovine Corneal Opacity and Permeability (BCOP) assay, was examined in agreement with OECD Guideline no. 437 (adopted on 26 July 2013), the Guidance Document OECD series on testing and assessment no. 160 and the method described in the document issued by U.S. EPA/OPP (31 May 2013). The test item was spread on each epithelial surface of three idoneous bovine corneas as supplied (150 mg/cornea); 0.75 mL of physiological saline was then added on each cornea in order to better distribute the substance on the cornea surface (final concentration on cornea = 200 mg/mL, approximately 20% w/v); an exposure period of 4 hours ± 10 minutes was used. The mean opacity detected with an opacitometer at the end of the test item exposure period was 0.3. At the macroscopic observation, no visible change of the treated corneas was noted. After the determination of opacity, the epithelial surface was treated with a 0.5% solution of sodium fluorescein in DPBS for 90 minutes, to investigate alteration in cornea permeability. The calculated mean permeability OD490 value of the corneas treated with the test item was 0.0389. The calculated in vitro irritancy score (IVIS) for the test item was 0.9. Positive and negative controls [a 20 % (w/v) Imidazole solution in physiological saline and physiological saline alone, respectively] were concurrently tested in similar conditions and gave the expected results. According to the OECD Guideline no. 437, the test item can be classified as “No Category”.