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EC number: 245-912-1 | CAS number: 23850-94-4
- 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
In vitro Skin Corrosion
Under the conditions of the study the test material was found to be corrosive to skin.
In vivo Eye Irritation
Under the conditions of the study the test material is an irritant to the eye.
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:
- 23 August 2017 to 24 August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Method B40 bis of Council Regulation (EC) No 440/2008
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Recommended test system in international guidelines
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Three-dimensional human skin model
- Supplier: MatTek In Vitro Life Science Laboratories, Bratislava, Slovak Republic
ASSESSMENT OF MTT INTERACTING SUBSTANCES
- In order to assess the potential non-specific reduction of the test material, 50 μL of test material was added to 1 mL of 1.0 mg/mL MTT and the colour change was assessed after incubation for 60 minutes at 37 ± 1°C, 5 ± 1% CO2, 95% RH. There was no change in colour therefore the test material did not interact with MTT.
ASSESSMENT FOR COLOUR INTERFERENCE
- 50 μL of test material was added to 0.3 mL of both deionised water and isopropanol and incubated for 60 minutes at 37 ± 1°C, 5 ± 1% CO2, 95% RH. Neither solution become coloured, therefore it was deemed not to have the potential to stain the tissue.
APPLICATION OF TEST MATERIAL AND CONTROL SUBSTANCES
- On the day of receipt EpiDerm™ tissues were transferred to refrigerator at 2 to 8°C and stored overnight. The next day, 1 hour 35 minutes before starting the assay, the tissues were prepared for treatment in labelled 6-well plates.
- The test was performed on a total of four tissues per test material, negative and positive control, out of which two were used for a 3 minute application and two tissues were used for a 1 hour application. A volume of 50 μL of the undiluted test material was applied to each tissue. Further tissues were concurrently treated with 50 μL distilled water (negative control) and with 50 μL 8N potassium hydroxide (positive control).
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37 ± 1°C (with MTT)
REMOVAL OF TEST MATERIAL AND CONTROLS
- After the 3 minute or 1 hour contact periods, the tissues were washed with phosphate buffered saline (PBS) to remove residual material. The rinsed tissues were kept in 24-well plates (holding plates) until all tissues were dosed and rinsed.
NUMBER OF REPLICATE TISSUES: 2 per exposure time
CELL VIABILITY MEASUREMENTS
- Once all tissues had been rinsed, they were transferred to wells containing 300 μL of 1 mg/mL MTT-medium and were incubated for 3 hours (37 ± 1°C, 5 ± 1% CO2, 95% RH).
- After incubation any resultant colour was extracted with 2 mL isopropanol overnight.
- The optical density of each resultant extract was determined spectrophotometrically at 570 nm and cell viability was calculated for each tissue as a percentage of the mean of the negative control tissue.
- Skin corrosivity potential of the test material was classified according to the remaining cell viability obtained after test material treatment with either of the two treatment times.
DATA EVALUATION
- Assay Acceptance Criteria:
The absolute OD570 of the negative control tissues in the MTT test is an indication of the tissue viability in the testing laboratory after the shipping and storage procedure and under specific conditions of the assay. The OD values for the negative controls should be ≥ 0.8 and ≤ 2.8, for this tissue model.
The OD values for the 60 minute positive controls should be < 15% when compared to that of the negative control.
The CV between the replicates should be ≤ 30%.
Both negative and positive control value must fall within the laboratory historical control values.
- Interpretation of Results:
The OD values obtained for each test sample are used to calculate the percentage viability relative to the negative control, which is arbitrarily set at 100%. The prediction of corrosivity associated with the EpiDerm™ model is as follows:
STEP 1:
< 50 % viability after 3 min exposure = Corrosive
≥ 50 % viability after 3 min exposure and < 15 % viability after 60 min exposure = Corrosive
≥ 50 % viability after 3 min exposure and ≥ 15 % viability after 60 min exposure = Non-corrosive
STEP 2 (for Substances/Mixtures Identified as Corrosive in Step 1):
< 25 % viability after 3 min exposure = Optional Sub-category 1A
≥ 25 % viability after 3 min exposure = A combination of optional Sub-categories 1B and 1C - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL
NEGATIVE CONTROL
- Amount(s) applied: 50 µL
POSITIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 8.0 N - Duration of treatment / exposure:
- 3 minutes of exposure and 1 hour of exposure
- Duration of post-treatment incubation (if applicable):
- Incubated for 3 hours with MTT
- Number of replicates:
- 2 per exposure time
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure
- Value:
- 27
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute exposure
- Value:
- 21.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - Skin viability after a three minute or one hour exposure to the test material was 27 and 21.2%, respectively.
- The OD values for the negative controls met the acceptance criteria.
- Skin viability after a three minute or one hour exposure to the positive control was 3 and 10.7%, respectively, demonstrating appropriate performance of the assay. - Interpretation of results:
- other: Corrosive (EU Criteria Category 1)
- Conclusions:
- Under the conditions of this study the test material was found to be corrosive to skin.
- Executive summary:
The potential of the test material to cause skin corrosion was investigated in accordance with the standardised guidelines OECD 431 and EU Method B.40bis, under GLP conditions. The study was conducted using the in vitro skin model EpiDerm™.
During the study, duplicate EpiDerm™ inserts were treated with test material, purified water (negative control) and 8N potassium hydroxide (positive control) for 3 minutes and 1 hour. At the end of the treatment period, the tissues were washed with phosphate buffered saline (PBS) and cell viability was assessed using the MTT assay. The skin corrosivity potential was classified according to the remaining cell viability obtained after test material treatment with either of the two treatment times.
Skin viability after a three minute or one hour exposure to the test material was 27 and 21.2 %, respectively. The OD values for the negative controls met the acceptance criteria. Skin viability after a three minute or one hour exposure to the positive control material was 3 and 10.7 %, respectively, demonstrating appropriate performance of the assay.
Under the conditions of this study the test material was found to be corrosive to skin.
Reference
Table 1: Summary of Results
Treatment |
Mean OD570 |
% Survival |
% CV |
|||
3 minutes |
60 minutes |
3 minutes |
60 minutes |
3 minutes |
60 minutes |
|
Negative control |
1.434 |
1.351 |
100 |
100 |
10.8 |
10.5 |
Test material |
0.384 |
0.287 |
27 |
21.2 |
17.1 |
8.7 |
Positive control |
0.292 |
0.354 |
3 |
10.7 |
6.9 |
15.0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 May 1979 to 21 May 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 9 weeks old
- Housing: The animals were housed 2/cage in suspended wire mesh cages (30 x 18 x 18 ")
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 21°C - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Duration of treatment / exposure:
- - The lids were held together briefly to ensure adequate distribution of the test material.
- The treated eyes of 6 rabbits remained unwashed. The treated eyes of 3 rabbits were washed 30 seconds after instillation - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 7 males and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- The treated eyes of 6 rabbits remained unwashed. The treated eyes of 3 rabbits were washed 30 seconds after instillation of the test material with 20 mL warm tap water.
SCORING SYSTEM:
- The general health of the rabbits was monitored during the observation period.
- The ocular reactions of the cornea, iris, and conjunctiva were graded at 1, 2, 3, 4 and 7 days after dosing. The eyes were graded by the Draize scoring system. In determining a positive or negative irritation effect only those scores recorded on Days 1, 2 and 3 were considered. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Reactions were severe in 4/6 unwashed eyes and included opacities which cleared in all but one by Day 7.
Reactions were severe in 1/3 washed eyes (included opacity on Day 2). All positive scores were clear by Day 3. - Interpretation of results:
- other: EU Criteria: Category 2 irritating to eyes
- Conclusions:
- Under the conditions of this study the test material was determined to be an eye irritant.
- Executive summary:
The potential of the test material to cause irritation to the eye was examined using rabbits according to a method similar to the standardised guideline OECD 405.
During the study, the test material (0.1 mL) was placed once into the conjunctival sac of one eye of each of nine rabbits. The lids were held together briefly to ensure adequate distribution of the test material. The untreated eye of each rabbit served as a control. The treated eyes of 6 rabbits remained unwashed. The treated eyes of 3 rabbits were washed 30 seconds after instillation of the test material with 20 mL warm tap water.
Reactions to the test material were severe in 4/6 unwashed eyes and included opacities which cleared in all but one by Day 7. Reactions were severe in 1/3 washed eyes (included opacity on Day 2). All positive scores were clear by Day 3.
Under the conditions of this study the test material was determined to be an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro Skin Corrosion
The potential of the test material to cause skin corrosion was investigated in vitro in accordance with the standardised guidelines OECD 431 and EU Method B.40bis, under GLP conditions. The study was conducted using the in vitro skin model EpiDerm™. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
During the study, duplicate EpiDerm™ inserts were treated with test material, purified water (negative control) and 8N potassium hydroxide (positive control) for 3 minutes and 1 hour. At the end of the treatment period, the tissues were washed with phosphate buffered saline (PBS) and cell viability was assessed using the MTT assay. The skin corrosivity potential was classified according to the remaining cell viability obtained after test material treatment with either of the two treatment times.
Skin viability after a three minute or one hour exposure to the test material was 27 and 21.2 %, respectively. The OD values for the negative controls met the acceptance criteria. Skin viability after a three minute or one hour exposure to the positive control material was 3 and 10.7 %, respectively, demonstrating appropriate performance of the assay.
Under the conditions of this study the test material was found to be corrosive to skin.
In vivo Eye Irritation
The potential of the test material to cause irritation to the eye was examined using rabbits. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
New Zealand White rabbits, approximately 8 weeks old when received, were equilibrated for at least one week in the laboratory. Nine apparently healthy rabbits, free from evidence of ocular irritation or damage, were selected for the test.
The test material (0.1 mL) was placed once into the conjunctival sac of one eye of each of nine rabbits. The lids were held together briefly to insure adequate distribution of the test material. The untreated eye of each rabbit served as a control. The treated eyes of 6 rabbits remained unwashed. The treated eyes of 3 rabbits were washed 30 seconds after instillation of the test material with 20 mL warm tap water.
Reactions were severe in 4/6 unwashed eyes and included opacities which cleared in all but one by Day 7. Reactions were severe in 1/3 washed eyes (included opacity on Day 2). All positive scores were clear by Day 3.
Under the conditions of this study the test material is an irritant to the eye.
Justification for classification or non-classification
Skin irritation :
According to Regulation EC no.1272/2008 (CLP), the test material is classified in the Category 1 "Causes severe skin burns and eye damage" (H314).
Eye irritation:
The test material is classified as Category 2 "Causes serious eye irritation" (H319) according to Regulation EC no.1272/2008 (CLP).
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