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EC number: 222-357-3 | CAS number: 3444-17-5
- 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:
- 2017-02-28 to 2017-06-09
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- adopted 26 July 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dated 27 April 2017
Test material
- Reference substance name:
- Chromium tris((2-ethylhexanoate)
- EC Number:
- 222-357-3
- EC Name:
- Chromium tris((2-ethylhexanoate)
- Cas Number:
- 3444-17-5
- Molecular formula:
- Cr(C8H16O2)3
- IUPAC Name:
- chromium(3+); 2-ethylhexanoate
- Test material form:
- other: Solid/paste
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- The test item was applied, on three gauzes (0.481g, 0.474g, and 0.508g) in order to cover the entire surface of the cornea. The gauzes were subsequently applied to 3 unucleated chicken eyes during 10 seconds such that the entire surface of the cornea was evenly covered with the test item. Then the eyes were rinsed twice with 10 mL of physiological saline at ambient temperature.
Concurrent negative control (physiological saline - Dutscher batch n° 3012316) and positive control (sodium hydroxide - Sigma batch n° MKBP7805V) were included in this experiment. One eye was treated with the negative control and three eyes were treated with the positive control. - Duration of post- treatment incubation (in vitro):
- All observations of the cornea and measurement of corneal thickness were performed using a Haag-Streit BP900 slit-lamp microscope with depth-measuring device n° I. For the measurement of corneal thickness, the slit-width was set at 9½ equalling 0.095 mm.
Treated corneas are evaluated pretreatment and starting at 30, 75, 120, 180 and 240 minutes (+/- 5 min.) after the post-treatment rinse. - Number of animals or in vitro replicates:
- 3 chicken eyes for main test, 1 chicken eye for negative control and 3 chicken eyes for positive control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 0 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 30 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 75 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 120 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 180 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 240 min
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 0 min
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 30 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 30 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 75 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 120 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 180 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 240 min
- Other effects / acceptance of results:
- Test item - Chromium 2-ethylhexanoate:
Corneal opacity: maximal mean score = 0.2 at 240 min corresponding to ICE class I
Fluorescein retention: maximal mean score = 1.0 at 30 min corresponding to ICE class II
Corneal swelling: maximal mean = + 1% at 240 min corresponding to ICE class I
Combination of the 3 endpoints: 2 x I, 1 x II
Positive control:
The combination of the 3 endpoints for the positive control, Sodium hydroxide, was 3 x IV. Therefore the positive control is classified as 'Corrosive/severe irritant' as expected.
Negative control:
The combination of the 3 endpoints for the negative control, physiological saline, was 3 x I. Therefore the negative control is classified as 'No category' as expected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with Regulation EC 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item does not require classification for eye irritation and serious eye damage as defined by the UN GHS (No Category). No signal word and hazard statement are required.
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