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EC number: - | CAS number: -
- 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:
- 2010-2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD-Guideline 437
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Slags, steelmaking (SMS)
- IUPAC Name:
- Slags, steelmaking (SMS)
- Reference substance name:
- Slag, pig iron ladle refining, non-granulated, water-cooled
- Molecular formula:
- not applicable because slags are UVCB
- IUPAC Name:
- Slag, pig iron ladle refining, non-granulated, water-cooled
- Details on test material:
- Name Slags, steelmaking - SMS, fine ground (< 90 µm)
Appearance grey granules (soldis)
Molecular formula not applicable (UVCB)
Molecular weight not applicable (UVCB)
Purity 100 w/w % slag
Homogeneity homogenous
Vapour pressure extremely low (melting point >300°C)
Stability solid slag is stable at room temperature
Solubility slightly soluble in water
Production date not stated (2009)
Expiry date 12/2024
Storage Room Temperature: (20 ± 5°C)
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: cow
- Strain:
- other: freshly bovine eyes from the slaughterhouse Müller Fleisch GmbH
- Details on test animals or tissues and environmental conditions:
- Freshly bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2.4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months. The eyes were transported to the test facility in Hank’s balanced salt solution with 0.01% streptomycin and 0.01% penicillin. Then the corneas were dissected and incu-bated with media at 32 ± 1°C in an incubation chamber for 1 hour.
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- For each treatment group (negative control, positive control and test item), three replicates were used. 750 µl negative control resp. eluate of the test item resp. positive control solu-tion were applied to each replicate.
- Duration of treatment / exposure:
- Exposition time on the corneas was 10 min at 32°C. After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, the anterior chamber was filled with cMEM without phenol red, and the corneas were stored for an additional two hours at 32°C (post-incubation).
- Number of animals or in vitro replicates:
- 0
- Details on study design:
- Chemicals
• Incubation Medium MEM (Minimum Essential Medium) without phenol red, Supplier Gibco/Invitrogen
• Incubation Medium MEM (Minimum Essential Medium) with phenol red, Supplier Gibco/Invitrogen
• Sodium bicarbonate NaHCO3, Supplier Merck
• L-glutamine, supplier: Biochrom AG
• 1% fetal calf serum, supplier PAN BioTech (EU approved)
• cMEM without phenol red: 495mL MEM are supplemented with 1.1 g NaHCO3, 5 mL FCS and 4.57 g L-Glutamine.
(As soon as the MEM without phenol red is supplemented with NaHCO3, FCS and L-Glutamine, it is designated in the following as cMEM ( = complete MEM) without phenol red.)
• cMEM with phenol red: 495 mL MEM are supplemented with 1.1 g NaHCO3, 5 mL FCS and 4.86 g L-Glutamine.
(As soon as the MEM with phenol red is supplemented with NaHCO3, FCS and L-Glutamine, it is designated in the following as cMEM ( = complete MEM) with phenol red.)
• Fluorescein-Na
• Hank’s Balanced Salt Solution (HBSS) without Phenol red, supplier: Life Technolo-gies
• 0.01% Penicillin-Streptomycin solution, supplier: PAN Biotech
Negative Control
• Sodium Chloride Solution: NaCl, CAS-No. 7647-14-5, 0.9% solution in deionised water
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- BCOP Test
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
Results
- Irritation parameter:
- other: lysis
- Basis:
- mean
- Time point:
- other: 10 minutes
- Score:
- 0.956
- Max. score:
- 0
- Reversibility:
- other: not relevant as no effect occured
- Irritant / corrosive response data:
- see Table 5
- Other effects:
- no relevant effect
Any other information on results incl. tables
In a test according to OECD TG 405 with solid material, irritation was observed. As was shown by SEM and other techniques, the test material was coarse and consisted of sharp-edged particles which apparently were the cause of the effect. The effect was fully reversible. In ISO 10993 "Biological Testing of Medicinal and Dental Materials and Devices Part 1: Guidance on Selection Tests" it is required that solid materials are tested as leachates.
Opacity and Permeability Values
The opacity values which were measured before and after exposition are given in the following table:
Table3 Opacity values
Test group |
Absorption at 570 nm |
Opacity before exposition |
Absorption at 570 nm |
Opacity |
Opacity |
Negative control 0.9% NaCl |
0.2017 |
1.5912 |
0.2206 |
1.6617 |
0.0705 |
0.2048 |
1.6026 |
0.2147 |
1.6395 |
0.0370 |
|
0.2054 |
1.6049 |
0.1788 |
1.5094 |
-0.0954 |
|
10052603G |
0.1821 |
1.5210 |
0.4262 |
2.6678 |
1.1468 |
0.2160 |
1.6443 |
0.4208 |
2.6351 |
0.9908 |
|
0.2366 |
1.7242 |
0.4267 |
2.6712 |
0.9470 |
|
Positive control 10% NaOH |
0.1531 |
1.4228 |
2.0438 |
110.6193 |
109.1966 |
0.2195 |
1.6575 |
2.2139 |
163.6342 |
161.9767 |
|
0.1278 |
1.3420 |
2.1291 |
134.6087 |
133.2667 |
Mean opacity difference of the negative control is 0.0040.
For the permeability measurement, a twelve-fold measurement of a medium blank (cMEM without phenol red) was performed. The mean optical density of 0.042 was subtracted from all measurements.
Three replicates for each cornea were measured. The optical density values at 490 nm are given in the following table:
Table4 Optical density at 490 nm
Repl. |
Negative control |
10052603G |
Positive control |
||||||
1 |
0.047 |
0.047 |
0.043 |
0.046 |
0.037 |
0.047 |
1.306 |
1.284 |
2.108 |
2 |
0.044 |
0.047 |
0.042 |
0.044 |
0.036 |
0.045 |
1.287 |
1.301 |
2.099 |
3 |
0.046 |
0.048 |
0.043 |
0.046 |
0.038 |
0.044 |
1.291 |
1.277 |
2.097 |
Mean |
0.046 |
0.047 |
0.043 |
0.045 |
0.037 |
0.045 |
1.295 |
1.287 |
2.101 |
Net |
0.004 |
0.005 |
0.001 |
0.003 |
-0.005 |
0.003 |
1.253 |
1.245 |
2.059 |
Net – Neg. Contr. |
0.000 |
-0.008 |
0.000 |
1.250 |
1.242 |
2.056 |
From all absorption means, the mean absorption of the medium blank (0.042) was subszracted, given the Net mean absorption. Then, the net mean absorption of the negative control (0.003) was substracted from the individual replicates of test item and positive control. Additionally, the path length of 1.695 was taken into account when calculating the IVIS.
IVIS Values The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Table5 IVIS
Test group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative control 0,9% NaCl |
0.1722 |
0.0890 |
154.6% |
0.1641 |
|||
-0.0700 |
|||
10052603G |
1.1428 |
0.9560 |
18.8% |
0.7834 |
|||
0.9430 |
|||
Positive control 10% NaOH |
140.9722 |
173.3520 |
16.3% |
193.5489 |
|||
185.5338 |
Note: the high relative standard deviation of the IVIS of test item and negative control is due to mathematical reasons, as the respective means are very small.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Slags, steelmaking - SMS have no irritation potential
- Executive summary:
One valid experiment was performed.
Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
The test item Slag, steelmaking - SMS, fine-ground (< 90 µm) was brought onto the cornea of a bovine eye which had been incubated with cMEM without Phenol red at 32±1°C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 10 minutes at 32±1°C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea.
10% sodium hydroxide solution was used as positive control. The positive control induced a very severe irritation on the cornea.
The test item Slag, steelmaking - SMS, fine-ground (< 90 µm) showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.956.
In conlcusion it can be stated, that in this study and under the experimental conditions reported, the test item Slag, steelmaking converter - BOS, fine ground (< 90 µm) possesses no eye irritation potential.
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