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EC number: 612-936-2 | CAS number: 62041-01-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 2017-06-26 to 2017-08-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- 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)
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Rifamycin, 3-amino-1,4-dideoxy-1,4-dihydro-4-imino-1-oxo-
- Cas Number:
- 62041-01-4
- Molecular formula:
- C37 H47 N3 O11
- IUPAC Name:
- Rifamycin, 3-amino-1,4-dideoxy-1,4-dihydro-4-imino-1-oxo-
Constituent 1
- Specific details on test material used for the study:
- Batch: 16012R87A
Purity: not specified
Test animals / tissue source
- Species:
- human
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability: In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimize the need of in vivo testing. One of the validated in vitro eye irritation tests is the EpiOcular test, which is recommended in international guidelines and scientific publications (e.g. OECD).
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live: The EpiOcular tissue construct is a non-keratinized epithelium (0.6 cm2) prepared from normal human keratinocytes (MatTek). It models the cornea epithelium with progressively stratified, but not cornified cells.
Test system
- 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): 51.3 to 61.2 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL sterile Milli-Q water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL Methyl Acetate (positive control) or Triton X (0.3%) - Duration of treatment / exposure:
- 6 hours ± 15 minutes
- Duration of post- treatment incubation (in vitro):
- 18 hours ± 15 minutes
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - RhCE tissue construct used, including batch number: EpiOcularTM (OCL-200-EIT MatTek Corporation, Lot: 23487 and 23491)
- Doses of test chemical and control substances used: 51.3 to 61.2 mg test item, 50 µL Milli-Q water (negative control) and 50 µL Methyl Acetate or Triton X (0.3%) (positive control).
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods: exposure period: 6 hours ± 15 minutes at 37.0 ± 1.0°C, post-exposure immersion: 25 ± 2 minute at room temperature, post-exposure incubation: 18 hours ± 15 minutes at 37°C.
- Description of the Interference of the Test Item with the MTT Endpoint
Test for Color Interference by the Test Item: the test item was checked for possible color interference before the study was started. Some non-colored test items may change into colored items in aqueous conditions and thus stain the tissues during the exposure. To assess the color interference, approximately 50 mg of the test item or 50 µL sterile Milli-Q water as a negative control was added to 1.0 mLMilli-Q water. The mixture was incubated for at least 1 hour at 37.0 ± 1.0°C in the dark. Furthermore, approximately 50 mg of test item or 50 µL sterile Milli-Q water as a negative control was added to 2.0 mL isopropanol. The mixture was incubated for 2 - 3 hours at room temperature with gentle shaking. At the end of the exposure time, the absorbance of the solutions was determined spectrophotometrically at 570 nm in duplicate with the TECAN Infinite® M200 Pro Plate Reader. Centrifugation was not considered necessary. If after subtraction of the negative control, the OD for the test item solution is >0.08, the test item is considered as possibly interacting with the MTT measurement. Since the test item showed color interference. A functional test with living skin tissues was performed to show that the test item did not bind to the tissue and resulted in a false MTT reduction signal.
Test for Reduction of MTT by the Test Item: The test item was checked for possible direct MTT reduction before the study was started. To assess the ability of the test item to reduce MTT, approximately 50 mg of the test item was added to 1 mL MTT solution (1 mg/mL MTT in phosphate buffered saline). The mixture was incubated for approximately 3 hours at 37.0 ± 1.0°C in the dark. A negative control, 50 µL sterile Milli-Q water was tested concurrently. If the MTT solution color turned blue / purple or if a blue / purple precipitate was observed the test item interacts with MTT. Only test items which bind to the tissue after rinsing can interact with MTT in the main assay.
- Number of tissue replicates used per test chemical and controls: 2
-ACCEPTABILITY CRITERIA, the in vitro eye irritation test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 of the two tissues of the negative control should reasonably be > 0.8 and < 2.5.
b) The mean relative tissue viability of the positive control should be <50% relative to the negative control.
c) The SD calculated from individual % tissue viabilities of the two identically treated replicates should be <20%.
d) The non-specific color of the test item should be ≤50% relative to the negative control OD.
-INTERPRETATION for ACCEPTABILITY CRITERIA
The test chemical is identified as not requiring classification and labelling according to UN GHS (No Category) if the mean percent tissue viability after exposure and post-exposure incubation is more than (>) 60%. In this case no further testing in other test methods is required.
The test chemical is identified as potentially requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after exposure and postexposure incubation is less than or equal (≤) to 60%.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: relative mean tissue viability%
- Run / experiment:
- first test
- Value:
- 58
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: the relative mean tissue viability obtained after 6 hours ± 15 minutes treatment with the test item compared to the negative control tissues
- Irritation parameter:
- other: relative mean tissue viability%
- Run / experiment:
- second test
- Value:
- 78
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: the relative mean tissue viability obtained after 6 hours ± 15 minutes treatment with the test item compared to the negative control tissues.
- Other effects / acceptance of results:
- OTHER EFFECTS:
-Visible damage on test system:
- Colour interference with MTT: the test item did not interfere with the MTT endpoint.
- Color interference in aqueous conditions: the test item induced color interference.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range.
- Acceptance criteria met for positive control: The positive control had a mean cell viability after 6 hours ± 15 minutes exposure is 1.9%. The positive control had a mean cell viability after 6 hours ± 15 minutes exposure is 29% in the second test.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-irritant
- Conclusions:
- The test item is non-irritant in the EpiOcularTM test under the experimental conditions described in this report.
- Executive summary:
The test item was topically applied on the Reconstructed Human EpiOcularTM Model to evaluate the potential eye hazard. The study procedures described in this report were based on OECD 492 (2015) guideline.
The test item (at least 50 mg) was applied directly on top of the tissue for 6 hours ± 15 minutes.
After exposure the cornea epithelial construct was thoroughly rinsed to remove the test item and transferred to fresh medium for an immersion incubation. Afterwards, the tissues were transferred to fresh medium and incubated for 18 hours at standard culture conditions, prior to determination of the cytotoxic (irritancy) effect.
The test item showed color interference in aqueous conditions. In addition to the normal procedure, two tissue were treated with test item. Instead of MTT solution these tissues were incubated with assay medium. The non-specific color of the test item was 0.53% of the negative control tissues. The OD of the treated tissues without MTT assay was subtracted from the ODs of the test item treated viable tissues with MTT assay.
Eye hazard potential is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 6 hours ± 15 minutes treatment with the test item compared to the negative control tissues was 58%. Since the individual viabilities were spread over 2 categories (individual values 55 and 61 respectively), the test was inconclusive and a repeat experiment was performed.
The non-specific color of the test item was 0.39% of the negative control tissues. The OD of the treated tissues without MTT assay was subtracted from the ODs of the test item treated viable tissues with MTT assay.
The relative mean tissue viability obtained after 6 hours ± 15 minutes treatment with the test item compared to the negative control tissues was 78% in the second test (individual values 82 and 75%, respectively). Since the mean relative tissue viability for the test item was above 60% after 6 hours ± 15 minutes treatment the test item is considered to be non-irritant in this test.
Overall since 3 out of 4 individual viabilities over 2 independent performed tests were above 60% the test item is considered to be non-irritant.
In conclusion, the test item is non-irritant in the EpiOcularTM test under the experimental conditions described in this report.
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