Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 27, 2017 - January 17, 2018
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Version / remarks:
2013
Deviations:
no
Qualifier:
according to
Guideline:
other: OPPTS 870.1000
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Composition: STB-FR (Benzenesulfonic acid, 2,4,5-trichloro-, sodium salt)
Lot #: 1710-06
Purity: 90.5%
CAS# 53423-65-7
EC# 258-548-3
Physical Description: White powder
pH: 7.11
Stability: Test substance was expected to be stable for the duration of testing.
Expiration Date: October 2019

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Isolated bovine cornea obtained from freshly slaughtered animals were used.

Test system

Vehicle:
water
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
The positive and negitive controls were 20% w/v Dibenzoyl-L-Tartaric Acid in 0.9% NaCl and 0.9% physiological saline (NaCl), respectively.
Duration of treatment / exposure:
4 hours
Duration of post- treatment incubation (in vitro):
90 minutes
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
mean
Value:
1
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
cornea opacity score
Run / experiment:
mean
Value:
-1
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
other: Corrected Optical Density
Run / experiment:
mean
Value:
0.114
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
In Vitro Irritancy Score (IVIS) = mean corrected opacity value + (15 x mean corrected OD-490 value)

Any other information on results incl. tables

CORRECTED OPACITY ANDIN VITROIRRITANCY SCORE:

Treated

Cornea #

Group

Treatment

Initial Opacity

Post Treatment Opacity

Change in Opacity

Corrected Opacity

Avg OD

Corrected OD

3

1

Negative Control
(0.9% NaCl)

3.6

4.3

0.7

 

0.015

 

6

1

Negative Control
(0.9% NaCl)

3.8

9.0

5.2

0.017

 

8

1

Negative Control
(0.9% NaCl)

4.8

4.3

-0.5

0.018

 

Mean

1.8

0.017

 

4

2

Positive Control
(20% Dibenzoyl-L-Tartaric Acid)

3.2

71.5

68.3

66.5

0.207

0.190

5

2

Positive Control
(20% Dibenzoyl-L-Tartaric Acid)

2.4

243.7

241.3

239.5

0.087

0.070

9

2

Positive Control
(20% Dibenzoyl-L-Tartaric Acid)

2.8

128.0

125.2

123.4

0.079

0.062

Mean

143.1

 

0.108

1

3

Test Substance
(STB-FR)

6.4

6.5

0.1

-1.7

0.169

0.152

2

3

Test Substance
(STB-FR)

3.1

3.4

0.3

-1.5

0.107

0.090

7

3

Test Substance
(STB-FR)

3.1

5.0

1.9

0.1

0.115

0.098

Mean

-1.0

 

0.114

Change in opacity = post treatment opacity – initial opacity

Corrected Opacity = Change in Opacity - Avg Change in Opacity of Negative Control Corneas

Background plate optical density compensated for by spectrophotometer.

Corrected OD = (Average Measured OD - Avg Measured OD of Negative Control)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was found to be non-irritating in the Bovine Corneal Opacity & Permeability (BCOP) Assay
Executive summary:

In this GLP guidline study conducted according to OECD method 437 and US EPA Method OPPTS 870.1000 using the Bovine Corneal Opacity & Permeability (BCOP) Assay, the subtance showed no signs for eye irritation potential and, thus, can be regarded as non-irritating according to UN GHS Criteria.