Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 258-548-3 | CAS number: 53423-65-7
Eye irritation
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:
- 2 018
- 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
- 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
Constituent 1
- 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 |
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)
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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
