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EC number: 284-902-1 | CAS number: 84989-13-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 April 2017 to 05 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzenesulfonic acid, 4-sec-decyl, ammonium salts
- Molecular formula:
- C16H29NO3S
- IUPAC Name:
- Benzenesulfonic acid, 4-sec-decyl, ammonium salts
- Reference substance name:
- Benzenesulfonic acid, 4-sec-undecyl, ammonium salts
- Molecular formula:
- C17H31NO3S
- IUPAC Name:
- Benzenesulfonic acid, 4-sec-undecyl, ammonium salts
- Reference substance name:
- Benzenesulfonic acid, 4-sec-dodecyl, ammonium salts
- Molecular formula:
- C18H33NO3S
- IUPAC Name:
- Benzenesulfonic acid, 4-sec-dodecyl, ammonium salts
- Reference substance name:
- Benzenesulfonic acid, 4-sec-tridecyl, ammonium salts
- Molecular formula:
- C19H35NO3S
- IUPAC Name:
- Benzenesulfonic acid, 4-sec-tridecyl, ammonium salts
- Test material form:
- other: Highly viscous light yellow liquid
- Details on test material:
- Storage Conditions: Highly viscous light yellow liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: n/a
- Specific activity: n/a
- Locations of the label: n/a
- Expiration date of radiochemical substance: n/a
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: applied undiluted
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none, applied as supplied
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: n/a
- Final preparation of a solid: n/a
FORM AS APPLIED IN THE TEST (if different from that of starting material): n/a
OTHER SPECIFICS: n/a
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Corneas from bovine eyes were obtained from a local abattoir.
- Number of animals: Not reported
- Characteristics of donor animals (e.g. age, sex, weight): Not reported
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were removed after slaughter, completely immersed in Hanks’ Balanced Salt Solution (containing penicillin at 100 IU/mL and streptomycin at 100 µg/mL) in a suitably sized container and transported on the same day to the testing facility.
- Time interval prior to initiating testing: Same day
- indication of any existing defects or lesions in ocular tissue samples: No
- Indication of any antibiotics used: Penicillin at 100 IU/mL and streptomycin at 100 µg/mL added to Hanks Balanced Salt Solution during transportation.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): n/a
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a - Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- n/a
- Duration of post- treatment incubation (in vitro):
- Following rinsing, the corneas were incubated (horizontally) for 2 hours after which, corneal opacity was measured and then the anterior chamber emptied.
For the permeability endpoint, 1 mL of sodium fluorescein (4 mg/mL solution) was added into the anterior chamber and the corneas were incubated in the vertical position for 1 hour and 25 minutes. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
On arrival at the test facility the eyes were carefully examined for defects including increased opacity, scratches and neovascularisation. Only corneas free from such defects were used.
QUALITY CHECK OF THE ISOLATED CORNEAS
The opacity of each cornea was measured using an opacitometer. Any corneas found to have scratches or increased neovascularization or an opacity of >7 opacity units when examined prior to treatment were discarded.
NUMBER OF REPLICATES
3 per treatment group
NEGATIVE CONTROL USED
The negative control substance was 0.9% sodium chloride solution (batch 17A09BB1C, expiry 13 May 2017) supplied by Baxter Healthcare Ltd., Thetford, UK.
SOLVENT CONTROL USED (if applicable)
N/A
POSITIVE CONTROL USED
The positive control substance was dimethyl formamide (DMF) (batch STBG0948, expiry March 2018) supplied by Sigma-Aldrich Company Ltd., Poole, UK.
APPLICATION DOSE AND EXPOSURE TIME
750 µL applied to each cornea and incubated at 32 ºC for 10 minutes.
TREATMENT METHOD
Closed chamber
POST-INCUBATION PERIOD
Following rinsing, the corneas were incubated (horizontally) for 2 hours after which, corneal opacity was measured and then the anterior chamber emptied. For the permeability endpoint, 1 mL of sodium fluorescein (4 mg/mL solution) was added into the anterior chamber and the corneas were incubated in the vertical position for 1 hour and 25 minutes.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: Each cornea was washed with media containing phenol red (as a pH indicator) until this indicator showed no pH effect occurring (and demonstrating that the test article had been removed successfully). The corneas were then washed once in media without phenol red
- POST-EXPOSURE INCUBATION: Following rinsing, the corneas were incubated (horizontally) for 2 hours after which, corneal opacity was measured and then the anterior chamber emptied. For the permeability endpoint, 1 mL of sodium fluorescein (4 mg/mL solution) was added into the anterior chamber and the corneas were incubated in the vertical position for 1 hour and 25 minutes.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer
- Corneal permeability: Passage of sodium fluorescein dye measured with the aid of spectrophotometer (OD490)
- Others (e.g, pertinent visual observations, histopathology): (please specify) N/A
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: As described in OECD 437.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 22.04
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control yields opacity and permeability values that are less than the established upper limits for these endpoints for bovine corneas as treated at the testing facility.
- Acceptance criteria met for positive control: The positive control yields an IVIS within 2 standard deviations of the historical control mean.
- Range of historical values if different from the ones specified in the test guideline: n/a
Any other information on results incl. tables
Table 1 Corneal Opacity
Test Substance |
Cornea Number |
Initial Opacity |
Post Incubation Opacity |
Change in Opacity |
Mean Change in Opacity |
Corrected Opacity |
Mean Corrected Opacity |
Test article |
9 |
-5 |
4 |
9 |
N/A |
10.7 |
7.0 |
10 |
-4 |
2 |
6 |
7.7 |
|||
11 |
-4 |
-3 |
1 |
2.7 |
|||
Negative |
1 |
-4 |
-5 |
-1 |
-1.67 |
0.7 |
0.0 |
2 |
-5 |
-7 |
-2 |
-0.3 |
|||
3 |
-4 |
-6 |
-2 |
-0.3 |
|||
Positive |
13 |
-3 |
66 |
69 |
N/A |
70.7 |
73.0 |
14 |
-5 |
69 |
74 |
75.7 |
|||
15 |
-5 |
66 |
71 |
72.7 |
Table 2 Corneal Permeability
Test Substance |
Cornea Number |
Mean Blank OD490 |
OD490 |
Corrected OD490 |
Mean Corrected OD490 |
Final Corrected OD490 |
Mean Group Corrected OD490 |
Test article |
9 |
|
0.999 |
0.999 |
N/A |
0.991 |
1.002 |
10 |
|
0.871 |
0.0871 |
0.863 |
|||
11 |
|
1.162 |
1162 |
1.154 |
|||
Negative |
1 |
|
0.011 |
0.011 |
0.008 |
0.003 |
0.000 |
2 |
0.006 |
0.006 |
-0.003 |
||||
3 |
0.008 |
0.008 |
0.000 |
||||
Positive |
13 |
|
0.121 |
0.121 |
N/A |
0.113 |
0.416 |
14 |
|
0.410 |
0.410 |
0.402 |
|||
15 |
|
0.741 |
0.741 |
0.733 |
Table 3 Calculated IVIS
Test Chemical |
Mean Opacity |
Mean Permeability |
IVIS (Mean Opacity + (15 x Mean Permeability)) |
Test article |
7.0 |
1.002 |
22.04 |
Negative control |
0 |
0 |
0 |
Positive control |
73.0 |
0.416 |
79.24 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- It was concluded that under the condition of this study, the test item, produced an IVIS score of 22.04 and therefore no prediction could be made in respect of its potential to cause eye irritation.
- Executive summary:
OECD 437 (2017) - The Bovine Corneal Opacity and Permeability (BCOP) test was conducted using Benzenesulfonic acid, 4 -C10 -13 -sec-alkyl derivs., ammonium salts in accordance with OECD Guideline 437 "Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage" (2013).
Undiluted test item was applied evenly to the surface of three corneas before being washed off with media solution after 10 minute test item contact time. A negative and positive control group, each containing 3 corneas, were also prepared.
Measurements for corneal opacity were made after 2 h incubation in the horizontal position with fresh media. Measurements for corneal permeability were made following 1 h and 25 min incubation in the vertical position with sodium fluorescein.
Corneal opacity and corneal permeability media solutions were analysed by a spectrophotometer at 490 nanometers (OD490). The mean corrected opacity reading and permeability readings for the test item were 7.0 and 1.002, resulting in an In Vitro Irritation Score (IVIS) of 22.04.
As a result, no prediction could be made in respect to the test items potential to cause eye irritation.
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