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EC number: 275-833-8 | CAS number: 71675-87-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 September 2014 - 26 September 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-amino-5-(ethylsulphonyl)-o-anisic acid
- EC Number:
- 275-833-8
- EC Name:
- 4-amino-5-(ethylsulphonyl)-o-anisic acid
- Cas Number:
- 71675-87-1
- Molecular formula:
- C10H13NO5S
- IUPAC Name:
- 4-amino-5-(ethanesulfonyl)-2-methoxybenzoic acid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Name of test material (as cited in study report): 4-amino-5-(ethylsulphonyl)-o-anisic acid
- Physical state: Solid
- Analytical purity: 99.81%
- Lot/batch No.: MP1032.31
In vitro test system
- Test system:
- isolated skin discs
- Source species:
- rat
- Source strain:
- Wistar
- Details on animal used as source of test system:
- SOURCE OF THE BIOLOGICAL MATERIAL:
TEST ANIMALS:
- Source: Centre for Experimental Medicine at the Medical University in Katowice
- Age at study initiation: 21 days old (hair follicles in dormant phase)
- Housing: Plastic cage covered with a wire bar lid. Dimensions: 58 x 37 x 21 cm. Bedding: UV-sterilized wood shavings.
- Diet (e.g. ad libitum): ad libitum, "Murigran” standard granulated laboratory fodder
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23 ºC
- Humidity (%): 55-70%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Vehicle:
- water
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used:The animals were euthanized by intraperitoneal administration of morbital at a dose of 200 mg/kg b.w.
After euthanasia, the dorso-lateral skin of each animal was removed and stripped of excess subcutaneous fat by carefully peeling it away from the skin using a paper towel. The skin discs were cut out using a scalpel. Each skin disc was placed over one of the ends of a PTFE (polytetrafluoroethylene) tube, ensuring that the epidermal surface was in contact with the tube. A rubber ‘O’ ring was press-fitted over the end of the tube to hold the skin in place and excess tissue is trimmed away. The rubber ‘O’ ring was then carefully sealed to the end of the PTFE tube with petroleum jelly. The tube was supported by a spring clip inside a receptor chamber containing MgSO4 solution (154 mM). The skin disc should be fully submerged in the MgSO4 solution. As many as 11 skin discs with a diameter of 20-mm each were obtained from a single rat skin. Two of them were used to control the quality of the procedure, whereas the remaining nine were used for the purpose of the experiment.
The age of the animals was particularly important. The age of 29 days ensures that the hair follicles are in the dormant phase before adult hair growth begins [SOP/T/57].
- Quality control for skin discs:
Before the test, the electrical resistance of two skin discs obtained from each rat was measured as a quality control procedure for each animal skin. Both discs should give resistance values greater than 10 kΩ for the remainder of the discs to be used for the test.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure:21-22ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 1 time washing with jet of tap water at up to 30ºC.
- Observable damage in the tissue due to washing:No
DYE BINDING METHOD
- Dye used in the dye-binding assay: [none / MTT / Sulforhodamine B / other:] : Not necessary,since all TER values for the test item were higher than 5 kΩ and there were not any visible changes on the skin discs.
NUMBER OF INDEPENDENT TESTING RUNS: 3 replicates
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the mean TER value obtained for the test item is less than or equal to 5 kΩ and the skin disc is obviously damaged.
- The test substance is considered to be non-corrosive to skin if the mean TER value obtained for the test item is greater than 5 kΩ, or the mean TER value is less than or equal to 5 kΩ, and the skin disc shows no obvious damage. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- VEHICLE
- Amount(s) applied (volume or weight with unit):test item moistened with 150 μL of destiled water.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):150 μL.
POSITIVE CONTROL
- Amount(s) applied (volume or weight):150 μL. - Duration of treatment / exposure:
- 24 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- MEAN TER value, TEST 1
- Value:
- ca. 15.75
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- SD+-041
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- MEAN TER value TEST 2
- Value:
- ca. 19.57
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- SD+- 0.43
- Irritation / corrosion parameter:
- other: Morphologics effects
- Remarks on result:
- not measured/tested
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system:No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: YES - the mean TER values were higher than 5 kΩ
- Acceptance criteria met for positive control: YES - the mean TER value is less than 5 kΩ.
The mean TER values for the test item were higher than 5 kΩ and there were not any visible changes on the skin discs.
Any other information on results incl. tables
On the grounds of the study, the test item belongs to a group of substances which do not lead to skin corrosion/severe irritation. The mean TER values for the test item were higher than 5 kΩ and there were not any visible changes on the skin discs.
Table No.1: Results of the control transcutaneous electrical resistance test (TER):
Animal number |
Skin disc number |
TER value (kΩ) |
1 |
1 |
17.14 |
2 |
16.57 |
|
2 |
1 |
14.72 |
2 |
13.98 |
The skin discs gave the resistance values greater than 10 kΩ; therefore, the remainder of the skin discs of the animals could have been used in the experiment.
Table No.2: Results of the transcutaneous electrical resistance test (TER):
Animal number |
Tested substance |
Skin disc number |
TER value (kΩ) |
Mean TER value ± SD (kΩ) |
1 |
Positive control – 36% HCl |
1 |
0.90 |
0.90 ± 0.01 |
2 |
0.89 |
|||
3 |
0.90 |
|||
Negative control – distilled water |
1 |
18.75 |
18.63 ± 0.46
|
|
2 |
18.13 |
|||
3 |
19.02 |
|||
Test item |
1 |
15.28 |
15.75 ± 0.41
|
|
2 |
16.03 |
|||
3 |
15.95 |
|||
2 |
Positive control – 36% HCl |
1 |
0.88 |
0.89 ± 0.01 |
2 |
0.88 |
|||
3 |
0.90 |
|||
Negative control – distilled water |
1 |
19.78 |
19.29 ± 1.11
|
|
2 |
19.01 |
|||
3 |
19.09 |
|||
Test item |
1 |
19.74 |
19.57 ± 0.52
|
|
2 |
19.08 |
|||
3 |
19.88 |
The concurrent mean values for the positive and negative controls were within the acceptable ranges for the method:
Positive control: 0.5-1.0 kΩ
Negative control: 10 -25 kΩ
The mean TER results for the skin discs treated with the test item were equal to 15.75 kΩ (animal no. 1) and 19.57 kΩ (animal no. 2).
Table No.3: Gross changes on the surface of the treated skin discs:
Animal number |
Tested substance |
Skin disc number |
Gross changes |
1 |
Positive control – 36% HCl |
1 |
perforation |
2 |
perforation |
||
3 |
perforation |
||
Negative control – distilled water |
1 |
no changes |
|
2 |
no changes |
||
3 |
no changes |
||
Test item |
1 |
no changes |
|
2 |
no changes |
||
3 |
no changes |
||
2 |
Positive control – 36% HCl |
1 |
perforation |
2 |
perforation |
||
3 |
perforation |
||
Negative control – distilled water |
1 |
no changes |
|
2 |
no changes |
||
3 |
no changes |
||
Test item |
1 |
no changes |
|
2 |
no changes |
||
3 |
no changes |
The gross examination showed that the positive control skin discs exhibited skin perforation, whereas the negative control skin discs and the ones treated with the test item did not reveal any changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- non-corrosive/severe irritant.
- Conclusions:
- The substance do not lead to skin corrosion/severe irritation. The mean TER values for the test item were higher than 5 kΩ and there were not any visible changes on the skin discs.
- Executive summary:
The in vitro skin corrosion: transcutaneous electrical resistance test (TER) was performed according to OECD Guideline 430 Guideline and EU Method B.40. Skin discs used in the experiment were obtained from two 29-day-old rats. The test item (ground to a powder) was uniformly applied to the epidermal surface of the skin disc placed inside a tube. Positive (36% hydrochloric acid) and negative (distilled water) controls were conducted concurrently. Three skin discs obtained from each animal were used for the test item and three for each control item. The test item and the control items were evenly applied to the discs for 24 hours and kept at 21-22°C. Then, they were removed by washing with a jet of tap water and the surface tension of the skin was reduced by adding 70% ethanol. After removing the ethanol the tissue was hydrated by the addition of 3 mL of a solution of MgSO4 (154 mM). A LCR 6401 low-voltage, alternating current databridge was used to measure the electrical resistance of the skin in kΩ by placing the databridge electrodes on either side of the skin disc. The skin discs were subjected to a gross examination. The mean TER results were equal to 15.75 kΩ (animal no. 1) and 19.57 kΩ (animal no. 2). The concurrent positive and negative control values fell within the acceptable ranges for the method. Gross examinations of the skin discs did not reveal any pathological changes. On the grounds of the study, it may be stated that the test item do not lead to skin corrosion/severe irritation. The mean TER values for the test item were higher than 5 kΩ and there were not any visible changes on the skin discs.
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