Benzoic acid, 5-methyl-2-(2H-1,2,3-triazol-2-yl)-

Eye irritation

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:

other: study performed according to standard in vitro methods; GLP-compliant (EPA, FDA)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Standard methods cited in literature

Principles of method if other than guideline:

Protocol based on methodology described in ‘Bovine Corneal Opacity and Permeability Test: An In Vitro Assay of Ocular Irritancy (1982)’; Gautheron, P., Dukic, M., Alix, D., and Sina, J.F.; Fundamental and Applied Toxicology, 18, 442-449. In Vitro classification based on Southee, J.A., 1998. Evaluation of the Prevalidation Process, Part 2, final report, volume 2, The Bovine Corneal Opacity and Permeability (BCOP) Assay.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoic acid

EC Number:

689-732-5

Cas Number:

956317-36-5

Molecular formula:

C10H9N3O2

IUPAC Name:

5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoic acid

Details on test material:

Purity > 98 %

Test system

Controls:

other: Not applicable

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): 20% solution in MEM (Minimum Essential Medium)

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Details on study design:

As per quoted methods.
In brief, five bovine corneas were 'dosed' with 0.75 mL of a 20% solution (in MEM, Minimum Essential Medium) of the test item. Opacity measurements and sodium fluorescein permeability were determined.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

ca. 112.8

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

The corrected mean optical score was 112.5. The corrected mean optical density (permeability) score was 0.018. The in vitro score in this BCOP study was calculated as 112.8 and, accordingly, the test item was classified as a very severe irritant.

Any other information on results incl. tables

Results

Individual Control Scores for BCOP

 

Cornea #:	Pretest	4 Hours	O.D. Scores
C3	0	0	0.043
C4	0	0	0.019
Mean	0	0	0.031
Corrected Mean Control Opacity Score	0

Corrected Mean Control Opacity Score = 4 hour mean score minus pretest mean score

Individual Test Scores

Cornea #	Pretest Scores				4 Hour Scores				O.D. Scores
11	C3	-2	C4	-3	C3	111	C4	110	0.072
12	C3	-2	C4	-2	C3	99	C4	98	0.012
13	C3	-2	C4	-3	C3	93	C4	92	0.043
14	C3	-2	C4	-3	C3	127	C4	127	0.058
15	C3	-3	C4	-4	C3	121	C4	121	0.060

 

Calculated Scores

Cornea #	Corrected Opacity Scores				Corrected O.D.
4 Hour Scores
11	C3	113	C4	113	0.041
12	C3	101	C4	100	-0.019
13	C3	95	C4	95	0.012
14	C3	129	C4	130	0.027
15	C3	124	C4	125	0.029
Corrected Mean Optical Density =					0.018
Corrected Mean Optical Score =					112.5

Corrected Mean Opacity Score (CMOS) = mean treated opacity score minus corrected mean control opacity score

CMOS = 112.5 + 15 (0.018)

CMOS = 112.5 + (0.270)

CMOS = 112.8

Applicant's summary and conclusion

Interpretation of results:

other: highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The in vitro score in this BCOP study was calculated as 112.8 and, accordingly, the test item was classified as a very severe irritant.

Executive summary:

This study protocol is based on methodology described in ‘Bovine Corneal Opacity and Permeability Test: An In Vitro Assay of Ocular Irritancy (1982)’. Five bovine corneas were 'dosed' with 0.75 mL of a 20% solution (in MEM, Minimum Essential Medium) of the test item. Opacity measurements and sodium fluorescein permeability were determined. The in vitro score in this BCOP study was calculated as 112.8 and, accordingly, the test item was classified as a very severe irritant.