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EC number: 943-834-9 | 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
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion: Skin irritation/corrosion study did not need to be conducted, as available acute toxicity study by dermal route (endpoint 7.2.3) did not indicate skin irritation up to the relevant limit dose level (2000 mg/kg body weight).
Eye Irritation:
Tested according to OECD Test Guideline No. 437 :
Damage by the test item is assessed by quantitative measurements of changes in corneal opacity and permeability with an opacitometer and visible light spectrophotometer, respectively. Both measurements are used to calculate an IVIS (In Vitro Irritancy Score), which is used to assign an in vitro irritancy hazard classification category for prediction of an in vivo ocular irritation of the test item.
Eyes were collected by slaughterhouse employees. The eyes were enucleated as soon as possible after death. The eyes, once they arrive at the laboratory, were carefully examined for defects including scratched, and neovascularisation. Only corneas from eyes free of such defects were used. Nine corneas were used for the study. Isolated corneas were mounted in specially designed corneal holders that consisted of anterior and posterior compartments respectively. Both chambers were filled to excess with pre-warmed Eagle's Minimum Essential Medium (EMEM). The device was then equilibrated at 32 ± 1°C for at least one hour in water bath to allow the corneas to equilibrate with the medium and to achieve normal metabolic activity, to the extent possible. Fresh pre-warmed EMEM was added to both chambers and baseline opacity readings were taken for each cornea. The testing was performed on three groups of corneas: test item treatment group, positive control group (20% w/v imidazole in 0.9% NaCl solution) and negative control group (0.9% NaCl solution). Each test group consisted of the three corneas.
The test item was tested as suspension prepared from test item at 20% concentration in a 0.9% sodium chloride solution. 2g of the test item was suspended in 10 mL of 0.9% sodium chloride solution. The open-chamber method was used, because the test item solution was not applicable by micropipette. The test item (enough to completely cover the cornea) was applied directly to the epithelial surface of the cornea using inject syringe. After dosing, the glass window was replaced on the anterior chamber to recreate a closed system. The controls were included in the BCOP test method so that nonspecific changes in the test system could be detected and to provide a baseline for the assay endpoints. Appearance of corneas was observed before and after application of the test item, negative and positive control. No macroscopic damage was observed on corneas before application. Corneal opacity was observed on the corneas treated by the positive control. The corneas treated by test item and negative control were without macroscopic damage.
The opacity and permeability of each cornea were recorded. The In Vitro Irritancy Score (IVIS) was calculated from the values of opacity and permeability. The study met all the acceptance criteria for positive and negative controls. The In Vitro Irritancy Score (IVIS) for Dried Sludge from domestic wastewater was 1.00. This value of IVIS is ≤ 3 therefore the classification of test item effect according to UN GHS criteria for eye irritation or serious eye damage is: No category.
Key value for chemical safety assessment
Skin irritation / corrosion
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:
- 15.09.2021-16.09.2021
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- cattle
- Strain:
- other: Bovine
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The test item was tested as suspension prepared from test item at 20% concentration in a 0.9% sodium chloride solution.
2g of the test item was suspended in 10 mL of 0.9% sodium chloride solution. - Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- 1.5 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Scheme
Selection of corneas, mounting in holders → incubation with EMEM 1hour (32 ± 1°C) → removed EMEM, measurement of baseline opacity → treatment by positive and negative control substances and test item (incubation 4 hours) → washing of epithelium, measurement of opacity after application → application of sodium fluorescein (5 mg/ml), incubation 1.5 hour (32 ± 1°C) → measurement of absorbance (490 nm). - Irritation parameter:
- in vitro irritation score
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study met all the acceptance criteria for positive and negative controls. The In Vitro Irritancy Score (IVIS) for test item, Dried Sludge from domestic wastewater was 1.00.
This value of IVIS is ≤ 3 therefore the classification of test item effect according to UN GHS criteria for eye irritation or serious eye damage is: No category. - Executive summary:
The test item, Dried Sludge from domestic wastewater, was tested for the potential to cause ocular corrosivity or severe irritancy, as measured by its ability to induce opacity and increased permeability in an isolated bovine cornea. The test was performed according to OECD Test Guideline No. 437 (2017) and Method B.47 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, Commission Regulation (EU) 2017/735, Adopted 14th February 2017.
The testing was performed on three groups of corneas: test item treatment group, positive control group (20% w/v imidazole in 0.9% NaCl solution) and negative control group (0.9% NaCl solution). Three corneas per group were used.
The open-chamber method was used, because the test item solution was not applicable by micropipette. The test item (enough to completely cover the cornea) was applied directly to the epithelial surface of the cornea using inject syringe.
Corneas were exposed for 4 hours.The opacity and permeability of each cornea were measured. The In Vitro Irritancy Score (IVIS) was calculated from the values of opacity and permeability.
The study met all the acceptance criteria for positive and negative controls. The In Vitro Irritancy Score (IVIS) for Dried Sludge from domestic wastewater was 1.00.
This value of IVIS is ≤ 3 therefore the classification of test item effect according to UN GHS criteria for eye irritation or serious eye damage is: No category.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
- no adverse effects were observed in the Eye irritation study (OECD Test Guideline No. 437)
- no skin irritation effects were observed up to the limit dose level of 2000mg/kg body weight in acute toxicity study conducted by dermal route (OECD Guideline 402)
The substance is not classified as an irritant according to the CLP regulation as:
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