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EC number: 228-667-5 | CAS number: 6320-03-2
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation / corrosion: Key study. Method according to OECD 430, GLP study. The test item is corrosive to the skin.
Eye irritation: Data waiving (study scientifically not necessary / other information available): According to column 2 of Annex VII of REACH, the study need not be conducted because the substance is classified as corrosive to the skin, leading to classification as serious eye damage (Category 1)”.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 30th to March 4th, 2016.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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 system:
- isolated skin discs
- Source species:
- rat
- Cell source:
- other: The test was conducted with skin discs collected from three Wistar (outbred) female rats.
- Source strain:
- Wistar
- Details on animal used as source of test system:
- SOURCE ANIMAL
- Source: Conventional husbandry of laboratory animals of the Centre for Experimental Medicine at the Medical University in Katowice.
- Sex: females
- Age at study initiation: 21 days old.
- Housing: Rats were kept in a plastic cage covered with a wire bar lid. The dimensions of the cage were 58 x 37 x 21 cm.UV-sterilized wood shavings were used as bedding.
- Diet: Murigran standard granulated laboratory fodder ad libitum
- Water: Tap water ad libitum
- Acclimation period: 4 days of quarantine for observation.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 -22 ºC
- Humidity (%): 35 - 47%
- Air changes (per hr): 16 times/hour
- Photoperiod: 12 hours light/12 hours dark - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used: After the quarantine, the dorsal and flank hair from young, 25-day-old, female rats was carefully removed with a shaver. Then, the shaven area was washed with an antibiotic solution containing streptomycin (10 mg/mL), penicillin (10 μg/mL), and amphotericin (0.25 mg/mL) to inhibit bacterial growth. The animals were washed with antibiotics again on the third day after the first wash and used in the study within one day of the second wash. The animals were euthanized by intraperitoneal administration of morbital at a dose of 200 mg/kg bw within one day of the second wash.
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.
- Quality control for skin discs: Electrical resistance obtained with two of the isolated skin discs was > 10 kΩ.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 21 -22 ºC
- Temperature of post-treatment incubation (if applicable):
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: the test item and the control items were removed by washing with a jet of tap water at up to 30°C.
- Observable damage in the tissue due to washing: no.
- Modifications to validated SOP: no.
DYE BINDING METHOD
- Dye used in the dye-binding assay: none / Sulforhodamine B
- Spectrophotometer:
- Wavelength:
- Filter:
- Filter bandwidth:
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if [complete, e.g. if the mean TER value is less than or equal to 5 kΩ and the skin disk is obviously damaged, or if the mean TER value is less than or equal to 5 kΩ, and the skin disc is showing no obvious damage, but the mean disc dye content is greater than or equal to the mean disc dye content of the 10M HCl positive control obtained concurrently.]
- The test substance is considered to be non-corrosive to skin if [complete, e.g. if the mean TER value obtained for the test substance is greater than 5 kΩ, or if the mean TER value is less than or equal to 5 kΩ, and the skin disc is showing no obvious damage, and the mean disc dye content is well below the mean disc dye content of the 10M HCl positive control obtained concurrently.]
- Justification for the selection of the cut-off point(s) if different than recommended in TG 430: - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 150 µL (undiluted).
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution): - Duration of treatment / exposure:
- 24 h
- Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Skin discs were used as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 150 µL. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- Not applicable.
- Number of animals:
- Discs were collected from 3 animals.
- Details on study design:
- TEST SITE
- Area of exposure: 20 mm each skin disk.
REMOVAL OF TEST SUBSTANCE
- Washing: Jet of tap water at up to 30ºC
- Time after start of exposure: 24 h. - Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- 1
- Value:
- 4.63
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: mean Skin discs from animal number 1. Time point: 24 hours. Max. score: 4.89. Reversibility: Not applicable.. Remarks: 4.63 ± 0.32. (migrated information)
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- 2
- Value:
- 4.87
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: mean Skin discs from animal number 2. Time point: 24 hours. Max. score: 5.01. Reversibility: other: Not applicable. Remarks: 4.87 ± 0.12. (migrated information)
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- 3
- Value:
- 4.89
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: mean Skin discs from animal number 3. Time point: 24 hours. Max. score: 5.01. Reversibility: other: Not applicable.. Remarks: 4.89 ± 0.13. (migrated information)
- Irritation / corrosion parameter:
- dye content (µg/disc)
- Run / experiment:
- 1
- Value:
- 67.07
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: mean : Test item, skin discs from animal number 1. Time point: Approximately 43 hours. Max. score: 68.75. Reversibility: other: Not applicable.. Remarks: 67.07 ± 1.51. (migrated information)
- Irritation / corrosion parameter:
- dye content (µg/disc)
- Run / experiment:
- 2
- Value:
- 80.51
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: mean : Test item, skin discs from animal number 2. Time point: Approximately 43 hours. Max. score: 81.27. Reversibility: other: Not applicable.. Remarks: 80.51 ± 0.82. (migrated information)
- Irritation / corrosion parameter:
- dye content (µg/disc)
- Run / experiment:
- 3
- Value:
- 79.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: mean : Test item, skin discs from animal number 3. Time point: Approximately 43 hours. Max. score: 81.92. Reversibility: other: Not applicable.. Remarks: 79.7 ± 2.01. (migrated information)
- Other effects / acceptance of results:
- The test item was considered corrosive because the mean TER values obtained for the test item were less than or equal to (≤) 5 kΩ and the skin disks showed no obvious damage but the mean dye content was greater than or equal to (≥) the mean disc dye content of the 10M HCl positive control obtained concurrently.
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 skin changes. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was corrosive to the skin according to the UN GHS classification system for the rat skin transcutaneous electrical resistance test.
- Executive summary:
An in vitro skin corrosion study was conducted according to the Transcutaneous Electrical Resistance (TER) test method and OECD guideline 430 under GLP conditions. Skin discs were collected at a first stage from two female rats and at a second stage from one additional female rat, this was deemed necessary due to the disconcordant results between the first two testing runs. The skin discs were obtained from 29 day old animals, each of the three runs consisted of three skin replicates for the test item as well as three replicates for the positive (10M hydrochloric acid) and negative (distilled water) controls respectively. Before the test started, the transcutaneous electrical resistance of two skin discs were measured as quality control procedure, in all the cases the resistance values were superior than 10kΩ thus the other discs were appropriate for the testing. 150 µL of the test item and the positive and negative controls were applied for 24 hours and kept at 21 -22ºC, the TER was measured as recommended by the above mentioned guideline. Because the mean TER values were lower or equal to 5 kΩ and in absence of visual damage, a dye binding assay was included in the study. Following the TER assesment the magnesium sulphate was discharged from the tube and 150 µL of a 10 % solution of sulforhodamine B in distilled water were applied to the epidermal surface of each disc skin for 2 hours, the following procedures were conducted as recomended by the OECD guideline 430 and finally, the content of the dye was determined using a spectrophotometer at 565 nm. The test item was considered corrosive because the mean TER values obtained for the test item were less than or equal to (≤) 5 kΩ and the skin disks showed no obvious damage but the mean dye content was greater than or equal to (≥) the mean disc dye content of the 10M HCl positive control obtained concurrently.
Reference
Table 1. Results of the transcutaneous resistance test (TER).
Animal |
Tested substance |
Skin disc number |
TER value (kΩ) |
Mean TER value ± SD (kΩ) |
1 |
Positive control – |
1 |
0.92 |
0.91 ± 0.01 |
2 |
0.90 |
|||
3 |
0.90 |
|||
Negative control – |
1 |
18.52 |
18.91 ± 0.36 |
|
2 |
18.98 |
|||
3 |
19.23 |
|||
Test item |
1 |
4.73 |
4.63 ± 0.32 |
|
2 |
4.28 |
|||
3 |
4.89 |
|||
2 |
Positive control – |
1 |
0.83 |
0.84 ± 0.01 |
2 |
0.85 |
|||
3 |
0.85 |
|||
Negative control – |
1 |
17.03 |
17.34 ± 0.48 |
|
2 |
17.89 |
|||
3 |
17.10 |
|||
Test item |
1 |
5.01 |
4.87 ± 0.12 |
|
2 |
4.78 |
|||
3 |
4.83 |
|||
3 |
Positive control – |
1 |
0.86 |
0.87 ± 0.01 |
2 |
0.87 |
|||
3 |
0.88 |
|||
Negative control – |
1 |
14.75 |
15.05 ± 0.32 |
|
2 |
15.03 |
|||
3 |
15.38 |
|||
Test item |
1 |
4.92 |
4.89 ± 0.13 |
|
2 |
5.01 |
|||
3 |
4.75 |
Table 2. Gross changes on the surface of the treated skin discs.
Animal |
Tested substance |
Skin disc number |
Gross changes |
1 |
Positive control – |
1 |
perforation |
2 |
perforation |
||
3 |
perforation |
||
Negative control – distilled |
1 |
no changes |
|
2 |
no changes |
||
3 |
no changes |
||
Test item |
1 |
no changes |
|
2 |
no changes |
||
3 |
no changes |
||
2 |
Positive control – |
1 |
perforation |
2 |
perforation |
||
3 |
perforation |
||
Negative control – distilled |
1 |
no changes |
|
2 |
no changes |
||
3 |
no changes |
||
Test item |
1 |
no changes |
|
2 |
no changes |
||
3 |
no changes |
||
3 |
Positive control – |
1 |
perforation |
2 |
perforation |
||
3 |
perforation |
||
Negative control – distilled |
1 |
no changes |
|
2 |
no changes |
||
3 |
no changes |
||
Test item |
1 |
no changes |
|
2 |
no changes |
||
3 |
no changes |
Table 3. Results of the treated disc Sulforhodamine B dye content determination.
Animal |
Tested substance |
Skin disc number |
Optical density at 565 nm |
Dye c (µg/disc) oncentration |
Mean ± SD (µg/disc) dye concentration |
1 |
Positive control – |
1 |
0.495 |
80.46 |
79.05 ± 1.38 |
2 |
0.478 |
77.69 |
|||
3 |
0.486 |
78.99 |
|||
Negative control – |
1 |
0.109 |
17.72 |
17.55 ± 0.74 |
|
2 |
0.112 |
18.20 |
|||
3 |
0.103 |
16.74 |
|||
Test item |
1 |
0.423 |
68.75 |
67.07 ± 1.51 |
|
2 |
0.405 |
65.83 |
|||
3 |
0.410 |
66.64 |
|||
2 |
Positive control – |
1 |
0.503 |
81.76 |
79.75 ± 2.22 |
2 |
0.493 |
80.13 |
|||
3 |
0.476 |
77.37 |
|||
Negative control – |
1 |
0.101 |
16.42 |
16.74 ± 0.86 |
|
2 |
0.099 |
16.09 |
|||
3 |
0.109 |
17.72 |
|||
Test item |
1 |
0.500 |
81.27 |
80.51 ± 0.82 |
|
2 |
0.496 |
80.62 |
|||
3 |
0.490 |
79.64 |
|||
3 |
Positive control – |
1 |
0.473 |
76.88 |
78.51 ± 1.44 |
2 |
0.486 |
78.99 |
|||
3 |
0.490 |
79.64 |
|||
Negative control – |
1 |
0.101 |
16.42 |
16.58 ± 0.59 |
|
2 |
0.106 |
17.23 |
|||
3 |
0.099 |
16.09 |
|||
Test item |
1 |
0.504 |
81.92 |
79.70 ± 2.01 |
|
2 |
0.487 |
79.16 |
|||
3 |
0.480 |
78.02 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to column 2 of Annex VII of REACH, the study need not be conducted because the substance is classified as corrosive to the skin, leading to classification as serious eye damage (Category 1)”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available information, the substance is classified as Skin Corrosive Category 1, H314, and as Eye Damage Category 1, H318 according to CLP Regulation (EC) No. 1272/2008.
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