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EC number: 241-168-7 | CAS number: 17096-47-8
- 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: Data waiving (study scientifically not necessary): According to column 2 of REACH Annex VII, the study does not need to be conducted because an acute toxicity study by the dermal route is available for the test substance and does not indicate skin irritation up to 2 000 mg/kg body weight (limit dose test).
Serious eye damage/eye irritation: Key study. Method according to OECD guideline 437, GLP study. The test item cannot be predicted as not classified for eye irritation/serious eye damage or as causing serious eye damage with the BCOP test method.
Serious eye damage/eye irritation: Key study. Method according to OECD guideline 492, GLP study. Under the conditions of the test, no prediction can be made as the test substance is considered either eye irritant or inducing serious eye damage in the EpiOcular™ Eye Irritation Test.
Serious eye damage/eye irritation: Final conclusion on classification of the test substance: Based on the result obtained in the BCOP Test (OECD 437) it can be excluded that the test item should be classified as “Category 1”. Based on the result obtained in the EpiOcular™ Test (OECD 492) it can be excluded that the test item should be classified as “No category”, but no prediction can be made between Category 1 and Category 2. Thus, Category 2 (eye irrtation) should be the correct classification for the test substance.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to column 2 of REACH Annex VII, the study does not need to be conducted because an acute toxicity study by the dermal route is available for the test substance and does not indicate skin irritation up to 2 000 mg/kg body weight (limit dose test). - Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 February 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was phlegmatized in 15% water for safety reasons during transportation. Thus, the test item was dried under vacuum in the desiccator and weighed. This procedure was repeated until a constant weight was obtained for every replicate used in the test. Content of water obtained:
Replicate 1: 13.5%
Replicate 2: 15.1%
Replicate 3: 14.0% - Species:
- cattle
- Strain:
- other: Bos primigenius Taurus
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Müller Fleisch GmbH, Industriestraße 42, 75217 Birkenfeld, Germany.
- Number of animals: Not specified. 9 corneas received for the test.
- Characteristics of donor animals (e.g. age, sex, weight): Between 12 and 60 months old.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour and 5 minutes.
- Time interval prior to initiating testing: the test was performed on the day of the transport.
- indication of any existing defects or lesions in ocular tissue samples: None of the corneas received showed tissue damage; therefore, all corneas were used.
- Indication of any antibiotics used: Penicillin 100 U/mL, Streptomycin 100 µg/mL. - 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): 749.2 mg (replicate1), 614.9 mg (replicate2) and 668.1 mg (replicate3).
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hr
- Duration of post- treatment incubation (in vitro):
- Not performed.
- Number of animals or in vitro replicates:
- 3 replicates.
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
After the arrival of the corneas, they were examined and only corneas which were free from damages were used. The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM (32 ± 1ºC) without phenol red was filled. The holders were then incubated for 1 hour in the incubation chamber at 32 ± 1ºC.
MEM: Minimum Essential Medium
cMEM (complete MEM): MEM supplemented with sodium bicarbonate, L-glutamine and 1% fetal calf serum
QUALITY CHECK OF THE ISOLATED CORNEAS
Corneas which show any tissue damages or an opacity greater than seven opacity units should be discarded.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: yes, Hank’s Balanced Salt Solution (HBSS).
POSITIVE CONTROL USED: yes, 20% imidazole solution in HBSS.
APPLICATION DOSE AND EXPOSURE TIME: 615 to 750 mg (test item tested neat) and 750 μL (negative and positive controls) , 4 h exposure.
TREATMENT METHOD:
The open chamber method was used for the test item.
The closed chamber method was used for the controls.
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least three times or until no visual evidence of test chemical was observed.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer BASF OP 3.0.
- Corneal permeability: passage of sodium fluorescein dye (optical density at 492 nm) measured with microtiter plate photometer (Anthos Reader 2010 Flexi).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: as indicated in the TG (see table below). - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 3.52
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (0.99)
- Positive controls validity:
- valid
- Remarks:
- (111.39)
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- 3.53
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (0.89)
- Positive controls validity:
- valid
- Remarks:
- (87.20)
- Irritation parameter:
- other: permeability
- Run / experiment:
- mean
- Value:
- -0.001
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (0.0071)
- Positive controls validity:
- valid
- Remarks:
- (1.6128)
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no.
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- A test is considered acceptable if: the positive control gives an IVIS that falls within two standard deviations of the current historical mean and negative/solvent controls gives values of opacity and permeability lower than upper limits for background values.
- Acceptance criteria met for negative control: yes, HBSS response resulted in opacity and permeability values that are less than established upper limits for negative control opacity (2.81) and permeability values (0.07)
- Acceptance criteria met for positive control: yes, IVIS score of imidazole 20% was 111.39 which falls between two standard deviations of the historical mean i.e. 75.56 – 145.51. - Interpretation of results:
- other: No prediction can be made (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test item cannot be predicted as not classified for eye irritation/serious eye damage or as causing serious eye damage with the BCOP test method.
- Executive summary:
An in vitro Bovine Corneal Opacity and Permeability (BCOP) study was conducted in order to determine the potential severe eye damaging effects of the test item according to the OECD guideline 437 under GLP conditions. Three sets consisting of three corneas each were tested: the first set was the negative control and was treated using the closed chamber method with 750 μL Hank’s Balanced Salt Solution (HBSS); the second set was the positive control and was treated using the closed chamber method with 750 μL of 20% imidazole solution and the third set was treated using the open chamber method with 615 to 750 mg of test item without dilution. The corneas were exposed for 4 hours at 32ºC. After exposure, opacity of the corneas and fluorescein permeability were measured. Negative control showed No category (IVIS score 0.99) and resulted in opacity and permeability values that are less than the established upper limits for the background values. The positive control induced serious eye damage on the cornea (IVIS score 111.39) and was within two standard deviations of the current historical mean. The test item exhibited an IVIS score of 3.52, thus cannot be predicted as not classified for eye irritation/serious eye damage or as causing serious eye damage with the BCOP test method.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 May 2020 - 07 May 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was phlegmatized in 15% water for safety reasons during transportation. Thus, the test item was dried under vacuum in the desiccator and weighed. This procedure was repeated until a constant weight was obtained for every replicate used in the test. Content of water obtained:
Replicate 1: 14.6%
Replicate 2: 13.6%
Replicate 3: 10.5%
Replicate 4: 8.7% - Species:
- human
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability: The EpiOcular™ model and the corresponding test method have been validated for irritation testing in an international validation study and its use is recommended by the relevant OECD guideline (OECD No. 492), and the method is applicable to mixtures, solids, liquids, semi-solids and waxes. Therefore, it was considered to be suitable for this study.
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live: The test was performed using EpiOcular™ Reconstructed Human Corneum Epithelium (RhCE) from MatTek Corporation. The system consists of normal, human-derived corneal keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells. These cells are not transformed or transfected with genes to induce an extended life span. The EpiOcularTM tissues are cultured in specially prepared cell culture inserts with a porous membrane through which nutrients can pass to the cells. The tissue surface is 0.6 cm2. The certificate of Analysis of the test system is included in the report. The tissue viability and barrier function tests are within the acceptable ranges and indicate the appropiate formation of the mucosal barrier and a viable basal cell layer. Tissues were used within 48 h of their delivery.
The cells used to produce EpiOcular (TM) tissue are screened for potential biological contaminants:
- HIV-1 virus - oligonucleotide-directed amplification: Not detected.
- Hepatitis B virus - oligonucleotide-directed amplification: Not detected.
- Hepatitis C virus - oligonucleotide-directed amplification: Not detected.
- Bacteria, yeast and other fungi - long term antibiotic, antimycotic free culture: Not detected. - 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): 51.5 and 54.6 mg for each replicate. - Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18 hours +15 min
- Number of animals or in vitro replicates:
- 2 tissues per test substance and for each control were used.
- Details on study design:
- - Details of the test procedure used: Two tissues (0.6 cm2) were pre-wetted with 20 µL DPBS buffer, incubated for 30 min, then dosed topically with 50 mg test item and exposed for 6 hours at 37ºC, 5% CO2, ≥ 95% RH. After exposure, the tissues were rinsed with DPBS, transferred to fresh assay medium, and incubated for 25 min. Then, they were transferred to fresh medium again and incubated for 18 hours and 15 min at 37ºC, 5% CO2, ≥ 95% RH.
The MTT assay for cell viability evaluation was performed on the tissues, by incubating them for 3 hours with MTT solution at 37ºC, 5% CO2, ≥ 95% RH. The precipitated formazan crystals were then extracted using isopropanol and quantified spectrophotometrically.
- RhCE tissue construct used, including batch number: RhCE EpiOcular™, Source: MatTek Corporation (Mylnské Nivy 73, 82105 Bratislava, Slovakia.), Tissue batch number(s): 30657, delivery date: 05. May 2020. The EpiOcular tissues were used within 48 hours of their delivery.
- Doses of test chemical and control substances used: 50 mg test item, 50 µL in controls.
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods: exposure 6 h at 37ºC, 5% CO2; post-exposure immersion 25 min at room temperature; post-exposure incubation 18 h at 37ºC, 5% CO2.
- Number of tissue replicates used per test chemical and controls: 2 tissues per test substance and for each control were used.
- Wavelength and band pass used for quantifying MTT formazan, and linearity range of measuring device: Wavelength: 570 nm.
- Description of the method used to quantify MTT formazan: Optical density by microtiter plate photometer.
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model: According to OECD 492, the percentage tissue viability cut-off value distinguishing classified from non-classified test chemicals is 60%. Therefore, the test item is identified as not requiring classification if the mean percent tissue viability after exposure and post-exposure incubation is > 60%. Otherwise, the test item is identified as potentially requiring classification and labelling.
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria: see table below.
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals: The validity of the RhCE EpiOcular™ test at laboratory facility was demonstrated in a proficiency study. For this purpose 15 proficiency chemicals (indicated by the OECD 492 guideline) were tested. All of the 15 proficiency chemicals were correctly categorized.
- Positive and negative control means and acceptance ranges based on historical data: see table below.
- Acceptable variability between tissue replicates for positive and negative controls: yes, 4.7% (negative control) and 1.9% (positive control). The values for negative and positive controls were below 20% (OECD Guideline 492).
- Acceptable variability between tissue replicates for the test chemical: yes, 1.6% below 20% (OECD Guideline 492). - Irritation parameter:
- other: cell viability (%)
- Run / experiment:
- mean
- Value:
- 23.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- 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: yes (mean OD = 1.9; demanded > 0.8 and < 2.8)
- Acceptance criteria met for positive control: yes (mean cell viability = 30.4%; demanded < 50% of negative control) - Interpretation of results:
- other: No prediction can be made (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Under the conditions of the test, no prediction can be made as the test substance is considered either eye irritant or inducing serious eye damage in the EpiOcular™ Eye Irritation Test.
- Executive summary:
An in vitro EIT study according to OECD 492 was conducted under GLP conditions to assess the irritation potential of the test item. Preliminary tests were performed to detect the ability of the test item to directly reduce MTT as well as its colouring potential. Based on the preliminary tests, two tissues (0.6 cm2) were pre-wetted with 20 µL DPBS buffer, incubated for 30 min, then dosed topically with 50 mg test item and exposed for 6 hours at 37ºC, 5% CO2, ≥ 95% RH. After exposure, the tissues were rinsed with DPBS, transferred to fresh assay medium, and incubated for 25 min. Then, they were transferred to fresh medium again and incubated for 18 hours and 15 min at 37ºC, 5% CO2, ≥ 95% RH. The MTT assay for cell viability evaluation was performed on the tissues, by incubating them for 3 hours with MTT solution at 37ºC, 5% CO2, ≥ 95% RH. The precipitated formazan crystals were then extracted using isopropanol and quantified spectrophotometrically (OD at 570 nm) in order to determine cell viability. Concurrent positive and negative controls were run in parallel. All validity criteria were met. The relative mean viability of the EpiOcular™ tissues treated with the test item was 23.9%. This value is below the threshold for eye irritation potential (≤ 60%). Test items that induce values below the threshold are considered either eye irritant or inducing serious eye damage. Thus, no prediction can be made.
Referenceopen allclose all
Table1.1. Illuminance Values (Unit: LUX)
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
(I) Measured values before exposure |
1042 |
1050 |
1053 |
1016 |
1023 |
1027 |
1004 |
1004 |
1016 |
(I) Measured values after exposure |
1020 |
1027 |
1033 |
914 |
932 |
935 |
342 |
324 |
337 |
Table 1.2. Opacity Values Negative Control
Parameter |
Negative Control |
||
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
2.84 |
2.52 |
2.40 |
Opacity after exposure |
3.75 |
3.46 |
3.21 |
Opacity Difference |
0.91 |
0.94 |
0.81 |
Mean Opacity Difference |
0.89 |
Table 1.3. Opacity Values Test Item and Positive Control
Parameter |
Test Item |
Positive Control |
||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
|
Opacity before exposure |
3.92 |
3.62 |
3.46 |
4.44 |
4.44 |
3.92 |
Opacity |
8.76 |
7.83 |
7.68 |
89.33 |
96.48 |
91.24 |
Opacity |
4.84 |
4.20 |
4.22 |
84.89 |
92.05 |
87.32 |
Opacity |
3.95 |
3.32 |
3.33 |
84.01 |
91.16 |
86.43 |
Mean Opacity |
3.53 |
87.20 |
Table 2.1. Optical density at 492 nm of Blank
Parameter |
cMEM without phenol red |
1. Measurement |
0.038 |
2. Measurement |
0.039 |
3. Measurement |
0.037 |
Mean |
0.038 |
Table 2.2. Optical density at 492 nm of Negative Control, Test Item and Positive Control
Parameter |
Negative Control |
Test Item |
Positive Control |
||||||
1. Rep. |
2. Rep. |
3. Rep. |
1. Rep. |
2. Rep. |
3. Rep. |
1.Rep. |
2.Rep. |
3.Rep. |
|
1. Measurement |
0.050 |
0.045 |
0.041 |
0.047 |
0.045 |
0.039 |
1.705 |
1.787 |
1.469 |
2. Measurement |
0.050 |
0.044 |
0.039 |
0.047 |
0.047 |
0.040 |
1.710 |
1.813 |
1.456 |
3. Measurement |
0.050 |
0.045 |
0.042 |
0.044 |
0.051 |
0.040 |
1.705 |
1.814 |
1.462 |
|
|||||||||
1. Measurement – blank |
0.0120 |
0.0070 |
0.0030 |
0.0090 |
0.0070 |
0.0010 |
1.6670 |
1.7490 |
1.4310 |
2. Measurement – blank |
0.0120 |
0.0060 |
0.0010 |
0.0090 |
0.0090 |
0.0020 |
1.6720 |
1.7750 |
1.4180 |
3. Measurement – blank |
0.0120 |
0.0070 |
0.0040 |
0.0060 |
0.0130 |
0.0020 |
1.6670 |
1.7760 |
1.4240 |
Mean of each replicate |
0.0120 |
0.0067 |
0.0027 |
0.0080 |
0.0097 |
0.0017 |
1.6687 |
1.7667 |
1.4243 |
Mean of the 3 replicates |
0.0071 |
-- |
-- |
||||||
Corrected |
-- |
-- |
-- |
0.0009 |
0.0026 |
-0.0054 |
1.6616 |
1.7596 |
1.4172 |
Corrected mean of the 3 replicates |
-- |
-0.0007 |
1.6128 |
Table 3. IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
1.09 |
0.99 |
12.81% |
1.04 |
|||
0.85 |
|||
Test Item |
3.96 |
3.52 |
10.93% |
3.35 |
|||
3.25 |
|||
Positive Control |
108.93 |
111.39 |
4.82% |
117.55 |
|||
107.69 |
*IVIS = Mean Opacity value + (15 × Mean Permeability value)
Table 1. Absorbance Values Blank Isopropanol (OD at 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Mean |
Absorbance |
0.032 |
0.033 |
0.033 |
0.035 |
0.033 |
0.034 |
0.034 |
0.035 |
0.034 |
Table 2. Absorbance Values Negative Control, Positive Control and Test Item (OD at 570 nm)
Designation |
Measurement |
Negative Control |
Positive Control |
Test Item |
Tissue 1 |
1 |
2.003 |
0.619 |
0.495 |
2 |
1.864 |
0.613 |
0.490 |
|
Tissue 2 |
1 |
1.861 |
0.583 |
0.461 |
2 |
1.831 |
0.579 |
0.464 |
Table 3. Mean Absorbance Negative Control, Positive Control and Test Item
Designation |
Negative Control |
Positive Control |
Test Item |
Mean – blank (Tissue 1) |
1.900 |
0.582 |
0.459 |
Mean – blank (Tissue 2) |
1.812 |
0.547 |
0.429 |
Table 4. % Viability Positive Control and Test Item
Designation |
Positive Control |
Test Item |
% Viability (Tissue 1) |
31.4% |
24.7% |
% Viability (Tissue 2) |
29.5% |
23.1% |
% Viability Mean |
30.4% |
23.9% |
Table 5. Validity
Criterion |
Demanded |
Found |
Mean OD of negative control |
>0.8 and< 2.8 |
1.9 |
% mean relative viability of positive control |
< 50% of negative control |
30.4% |
Variation within replicates |
< 20% |
4.7% (negative control) |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation/corrosion: Based on the available data, the substance is not classified for skin irritation according to CLP Regulation no. 1272/2008.
Serious eye damage/eye irritation: Based on the available data, the substance is classified in category 2 (eye irritation) according to CLP Regulation no. 1272/2008.
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.