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Administrative data

Description of key information

Skin Irritation / Corrosion: Not an irritatant or corrosive

Eye Damage / Irritation: Not an irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 February 2018 - 23 February 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Name:STB-FR
CAS No.: 53423-65-7
Batch No.: 1710-06
Aggregate State at RT: solid, powder
Color: white
Storage Conditions: room temperature
Purity: 90.5%
Expiry Date: October 2019
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: cultured on chemically modified, collagen-coated cell culture inserts.
Source strain:
not specified
Vehicle:
physiological saline
Details on test system:
Test system consisted of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The EpiDerm epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
25 mg (39 mg/cm2)
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test Item
Value:
97.4
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Result of the Test Item STB-FR:

Name

Negative Control

Positive Control

Test Item

Tissue

1

2

3

1

2

3

1

2

3

Absolute OD570

2.070

1.785

2.187

0.100

0.101

0.100

1.975

1.853

1.989

2.045

1.789

2.133

0.103

0.107

0.100

2.010

1.891

1.992

OD570(Blank Corrected)

2.027

1.741

2.144

0.057

0.057

0.056

1.932

1.809

1.945

2.002

1.746

2.090

0.060

0.063

0.057

1.966

1.847

1.948

Mean OD570of the Duplicates (Blank Corrected)

2.014

1.743

2.117

0.058

0.060

0.056

1.949

1.828

1.947

Total Mean OD570of 3 Replicate Tissues (Blank Corrected)

1.958*

0.058

1.908

SD OD570

0.193

0.002

0.069

Relative Tissue Viability [%]

102.9

89.0

108.1

3.0

3.1

2.9

99.5

93.4

99.4

Mean Relative Tissue Viability [%]

100.0

3.0**

97.4

SD Tissue Viability [%]***

9.8

0.1

3.5

CV [% Viabilities]

9.8

3.2

3.6

*Blank-corrected mean OD-570 mm of the negative control corresponds to 100% absolute tissue viability.

**Mean relative tissue viability of the three positive control tissues is </= 20%.

***Standard deviation (SD) obtained from the three concurrently tested tissues is </= 18%

Quality Criteria:

 

Value

Cut off

pass/fail

Mean Absolute OD570 nmNK

2.002

0.8 ≤ NK ≤2.8

pass

Mean Relative Viability [%] PC

3.0

≤ 20%

pass

SD Viability[%]

0.1% - 9.8%

≤ 18%

pass

Interpretation of results:
GHS criteria not met
Conclusions:
The test item showed no irritant effects.
Executive summary:

In this GLP guideline study conducted according to OECD test method 439 and EC method B.46 using the EpiDerm Standard Model (EPI-200) utilizing a reconstituted three-dimensional human epidermis, the test item showed no irritant effects. The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was 97.4% and, thus, the test item can be classified as “non-irritant” in accordance with UN GHS.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
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
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
Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Isolated bovine cornea obtained from freshly slaughtered animals were used.
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
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)

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)

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Not Classified: In in vitro GLP guideline studies, the substance was classified as non-irritating to skin and eyes.