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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
cattle

Test system

Vehicle:
Hank's balanced salt solution
Controls:
yes, concurrent positive control
yes, concurrent negative control
Duration of treatment / exposure:
Exposure time on the corneas was 4 hours at 32 ± 1 °C. After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, both chambers were filled with cMEM without phenol red, and the final opacity value of each cornea was recorded.

Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Value:
0.002
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Table 9.1‑d      Optical density at 492 nm of Blank

Parameter

cMEM without phenol red

1. Measurement

0.041

2. Measurement

0.035

3. Measurement

0.042

Mean

0.039

 

Table9.1‑e      Optical density at 492 nm of Negative Control, Test Item and Positive Control

Parameter

Negative Control

Test Item

Positive Control

1. Rep.

2. Rep.

3. Rep.

1. Rep.

2. Rep.

3. Rep.

1. Rep.

2. Rep.

3. Rep.

1. Measurement

0.068

0.050

0.060

0.055

0.051

0.056

1.435

2.137

1.411

2. Measurement

0.064

0.047

0.054

0.056

0.051

0.055

1.463

2.140

1.413

3. Measurement

0.069

0.048

0.050

0.055

0.056

0.058

1.465

2.143

1.396

 

1. Measurement – blank

0.0287

0.0107

0.0207

0.0157

0.0117

0.0167

1.3957

2.0977

1.3717

2. Measurement – blank

0.0247

0.0077

0.0147

0.0167

0.0117

0.0157

1.4237

2.1007

1.3737

3. Measurement – blank

0.0297

0.0087

0.0107

0.0157

0.0167

0.0187

1.4257

2.1037

1.3567

Mean of each replicate

0.0277

0.0090

0.0153

0.0160

0.0133

0.0170

1.4150

2.1007

1.3673

Mean of the

3 replicates

0.0173

--

--

Corrected

--

--

--

-0.0013

-0.0040

-0.0003

1.3977

2.0833

1.3500

Corrected mean of the

3 replicates

--

-0.0019

1.6103

Rep. = Replicate

 


 

IVIS Values

The calculated IVIS for each replicate and the corresponding means are presented in the following table:

Table9.2‑a      IVIS

Test Group

IVIS

Mean IVIS

Relative Standard Deviation IVIS

Negative Control
HBSS

0.37

1.81

69.47%

2.69

2.37

Test Item
N-(4-anilinophenyl)-4-methylbenzenesulfonamide

-2.27

 

-0.76

 

 

-178.15%

 

-0.32

0.32

Positive Control
20% imidazole solution

94.27

94.64

0.35%

94.74

94.90

 

Note: the high relative standard deviations of the IVIS of test item and negative control are due to mathematical reasons, as the respective means are very small.

Under the conditions of this study, the test item N-(4-anilinophenyl)-4-methylbenzenesulfonamide showed no effects on the cornea of the bovine eye. The calculated IVIS is -0.76.

According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.

Applicant's summary and conclusion

Conclusions:

no classification for eye irritation or serious eye damage.