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Diss Factsheets

Administrative data

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

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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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:
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.

In vitro test system

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

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test Item
Value:
97.4
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.