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EC number: 295-415-9 | CAS number: 92045-34-6
- 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:
- May 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD 437 study performed under GLP condititions
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: BCOP OECD 437
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Absorbent A4
- IUPAC Name:
- Absorbent A4
- Details on test material:
- - Name of test material (as cited in study report): Absorbent A4
- Substance type: UVCB
- Physical state: Transparent liquid without mechanical impurities, colour from light to dark
- Stability under test conditions: months
- Storage condition of test material: room temperature, in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: Freshly isolated bovine cornea
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Duration of treatment / exposure:
- 10 minutes of incubation
- Number of animals or in vitro replicates:
- Number of Corneae per Group: 3
Number of Test Item Group: 1
Number of Negative Control Groups: 1
Number of Positive Control Groups: 1
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: after 10 minutes incubation time
- Score:
- 0
- Max. score:
- 0.17
Any other information on results incl. tables
Table of Results
Results after 10 Minutes Incubation Time
Test Group |
Opacity value = Difference (t130-t0) of Opacity |
Permeability at 490 nm (OD490) |
In vitroScore |
Meanin vitroScore |
Proposedin vitroIrritation Scale |
||
|
|
Mean |
|
Mean |
|
|
|
Negative Control |
- 1 |
- 0.67 |
0.252 |
0.159 |
2.78 |
1.71 |
Non eye irritant |
0 |
0.069 |
1.04 |
|||||
- 1 |
0.155 |
1.33 |
|||||
Positive Control |
38.67* |
0.010* |
38.82 |
46.13 |
Moderate eye irritant |
||
34.67* |
0.292* |
39.05 |
|||||
52.67* |
0.522* |
60.50 |
|||||
Absorbent A4 |
0.67* |
- 0.109* |
- 0.96 |
0.00 |
Non eye irritant |
||
1.67* |
- 0.100* |
0.17 |
|||||
1.67* |
- 0.111* |
0.01 |
*corrected values
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: According to the INVITTOX (UK) protocol no. 98
- Conclusions:
- In conclusion, according to the current study and under the experimental conditions reported, the test item Absorbent A4 is not corrosive to the eye (EU CLP/GHS (cat. 1; H318)). Corresponding to the INVITTOX (UK) protocol no. 98 classification Absorbent A4 is non eye irritant.
- Executive summary:
This in vitro study was performed to assess thecorneal irritation and damage potential of Absorbent A4 by means of the BCOP assay using fresh bovine corneae.
The test item was tested undiluted. The positive control 2-Ethoxyethanol was tested neat. Saline was used as negative control item.
After a first opacity measurement of the fresh bovine corneae (t0), the neat test item Absorbent A4, the positive, and the negative controls were applied to corneae and incubated for 10 minutes at 32 ± 1 °C in complete medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae. Further, the corneae wereincubated for another 120 minutes at 32 ± 1 °C in complete medium, andopacity was measured a second time (t130).
After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.
With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean in vitro score 1.71).
The positive control (2-Ethoxyethanol) caused clear opacity and permeability effects on the corneae (mean in vitro score 46.13) corresponding to a classification as moderate irritating to the eye according to the INVITTOX (UK) protocol no. 98.
Relative to the negative control, the test item Absorbent A4 did not cause any increase of the corneal opacity of permeability. The calculated mean in vitro score was 0.00. According to the INVITTOX (UK) protocol no. 98 the test item is classified as non eye irritant.
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