Registration Dossier
Registration Dossier
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EC number: 258-548-3 | CAS number: 53423-65-7
Endpoint summary
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
- 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
- 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)
- 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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)
- 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.
Reference
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 |
3.6 |
4.3 |
0.7 |
|
0.015 |
|
6 |
1 |
Negative Control |
3.8 |
9.0 |
5.2 |
0.017 |
|
|
8 |
1 |
Negative Control |
4.8 |
4.3 |
-0.5 |
0.018 |
|
|
Mean |
1.8 |
0.017 |
|
|||||
4 |
2 |
Positive Control |
3.2 |
71.5 |
68.3 |
66.5 |
0.207 |
0.190 |
5 |
2 |
Positive Control |
2.4 |
243.7 |
241.3 |
239.5 |
0.087 |
0.070 |
9 |
2 |
Positive Control |
2.8 |
128.0 |
125.2 |
123.4 |
0.079 |
0.062 |
Mean |
143.1 |
|
0.108 |
|||||
1 |
3 |
Test Substance |
6.4 |
6.5 |
0.1 |
-1.7 |
0.169 |
0.152 |
2 |
3 |
Test Substance |
3.1 |
3.4 |
0.3 |
-1.5 |
0.107 |
0.090 |
7 |
3 |
Test Substance |
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)
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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