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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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
Guideline:
other: OPPTS 870.1000
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2,4,5-trichlorobenzenesulphonate
EC Number:
258-548-3
EC Name:
Sodium 2,4,5-trichlorobenzenesulphonate
Cas Number:
53423-65-7
Molecular formula:
C6H2Cl3O3S.Na
IUPAC Name:
sodium 2,4,5-trichlorobenzenesulfonate
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.