Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 March 2011 - 23 March 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD test guidelines, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 437. 7 September 2009, OECD Guideline for the Testing of Chemicals: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
The study report included a current certificate of GLP compliance for the test facility, issued by the MHRA.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Off-white solid
- Storage condition of test material: aprox. -20 degrees in the dark.

Test animals / tissue source

Species:
other: Bovine eyes.
Details on test animals or tissues and environmental conditions:
Bovine eyes, excised by an abattoir employee, were collected as soon after slaughter as possible (excised at 12.30 hours on 22 March 2011).
Instructions were given to avoid damaging the corneas during excision. Excised eyes were maintained and transported to the laboratory, at ambient
temperature, in sufficient HBSS, containing 1% (v/v) Penicillin/Streptomycin solution, to cover all the eyes in the receptacle. The eyes were used within
4 hours after slaughter (incubation of mounted corneas commenced at 15.18 hours, 22 March 2011).

Test system

Vehicle:
other: 0.9% sodium chloride solution.
Controls:
other: Concurrent positive and negative control corneas were examined.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750µL
- Concentration (if solution): 20% (w/w)
Duration of treatment / exposure:
4 hours ± 5 minutes at 32 ± 1 °C.
Observation period (in vivo):
Corneas were washed after the exposure period, then the opacity of each cornea was measured.
Number of animals or in vitro replicates:
Corneas were treated in triplicate with either the test substance, positive control compound or negative control (0.9% sodium chloride solution).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Opacity
Basis:
mean
Time point:
other: 4h
Score:
20.33
Remarks on result:
other: S.D. = 1.528
Irritation parameter:
other: Permeability
Basis:
mean
Time point:
other: 4h
Score:
0.233
Remarks on result:
other: S.D. = 0.102
Irritation parameter:
other: In vitro irritancy score
Basis:
mean
Time point:
other: 4h
Score:
23.8
Remarks on result:
other: S.D. = 0.4
Irritant / corrosive response data:
The in-vitro irritancy score of Imidazole, the positive control, was 120 ± 21.939 (standard deviation).

Any other information on results incl. tables

In Vitro Irritancy Score was calculated as (Corrected Opacity Value + (15 x Corrected OD490 Value)).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Interpretation is consistent with the criteria quoted in the OECD test guideline.
Conclusions:
The test substance elicited an In Vitro Irritancy Score of 23.8 ± 0.4 and was predicted to be a non-corrosive/non-severe eye irritant.
Executive summary:

An In-vitro eye irritation / corrosion test was conducted by Huntingdon Life Sciences, UK, to assess the potential for eye irritation of the test substance. The study was conducted according to the OECD Test Guideline 437, and in compliance with GLP. The corneas from freshly excised Bovine eyes were exposed to a 20% (w/w) solution of the test substance in saline solution (sodium chloride 0.9% (w/v) solution) for four hours prior to washing, recording of the opacity, then determination of the permeability. The test substance elicited an in vitro Irritancy Score of 23.8 ± 0.4 and was predicted to be a non corrosive / non severe eye irritant.