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EC number: 860-352-3 | CAS number: 1610350-91-8
- 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:
- 2020-06-20 to 2020-08-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2S)-2-amino-3-(4-{[bis(sodiooxy)phosphoryl]oxy}phenyl)propanoic acid
- EC Number:
- 860-352-3
- Cas Number:
- 1610350-91-8
- Molecular formula:
- C9H10NO6PNa2
- IUPAC Name:
- (2S)-2-amino-3-(4-{[bis(sodiooxy)phosphoryl]oxy}phenyl)propanoic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 20% (w/v) suspension in a 0.9% sodium chloride solution
VEHICLE
- Concentration: 0.9% sodium chloride solution
- Lot/batch no.: 18163013 - Duration of treatment / exposure:
- 240 minutes at 32 ± 1°C
- Number of animals or in vitro replicates:
- 3 replicates per test item/ positive control/ negative control
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Freshly isolated bovine eyes of cattle were collected from the slaughterhouse. Excess tissue was removed from the eyes. The eyes were kept and transported in transport medium cooled on ice.
The corneas were prepared immediately after delivery of the eyes to the laboratory. The corneas were carefully removed from the eyes using scalpel and rounded scissors. A rim of about 2 to 3 mm of tissue (sclera) was left for stability and handling of the isolated cornea. All corneas used in the study were collected in incubation medium (pre-warmed at 32 ± 1°C) and the corneal diameter of each cornea was measured and recorded. Each cornea was mounted in a cornea holder (CiToxLAB, Veszprem, Hungary) with the endothelial side against the sealing ring (O-ring) of the posterior part of the holder. The cornea was gently flattened over the O-ring without stretching the cornea. Afterwards, the anterior part of the holder was positioned on top of the cornea and fixed in place with screws. Both compartments of the holder were filled with incubation medium. The posterior compartment was filled first to return the cornea to its natural convex form.
QUALITY CHECK OF THE ISOLATED CORNEAS
All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity or scratches were discarded.
NUMBER OF REPLICATES
3 replicates per test item/ positive control/ negative control
NEGATIVE CONTROL USED
0.9% sodium chloride solution
POSITIVE CONTROL USED
20% (w/v) imidazole in 0.9% sodium chloride solution
APPLICATION DOSE AND EXPOSURE TIME
- Test item: 20% (w/v) in 0.9% sodium chloride solution
- Positive control: 20% (w/v) in 0.9% sodium chloride solution
- Negative/vehicle control: 0.9% sodium chloride solution
- Exposure time: 240 minutes
TREATMENT METHOD:
- negative and positive control: closed chamber
- test item: open chamber
POST-INCUBATION PERIOD: No
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: Three times with wash medium
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity value of each individual cornea was corrected for background opacity by subtracting the initial baseline opacity reading from the post treatment opacity reading. In addition, the opacity values of both the treatment and positive control groups were corrected for the mean negative control opacity values. From the individual corrected opacity values, a mean corrected opacity value was calculated for each group.
- Corneal permeability: For each cornea either treated with the positive control or the test item, an individual corrected OD490 value was calculated by subtracting the average negative control permeability value from each individual permeability reading. From the individual corrected permeability values, a mean corrected permeability value was calculated for each group.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: decision criteria as indicated in the test guideline was used
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean of three corneas
- Value:
- 0.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 1: Opacity, permeability and in vitro irritancy scores calculated after treatment with the test item
| Opacity | Permeability | IVIS | |||
per cornea | per group (mean value) | Standard deviation | ||||
Negative control | 0.9% sodium chloride solution | -0.2 | 0.012 | -0.020 | 0.2 | 0.6 |
-0.5 | 0.012 | -0.320 | ||||
0.7 | 0.015 | 0.925 | ||||
Positive control | Imidazole (20%) | 74.2 | 2.639 | 113.785 | 103.8 | 8.8 |
73.9 | 1.556 | 97.240 | ||||
70.8 | 1.966 | 100.290 | ||||
Test item | Art. 137119 | 2.0 | -0.003 | 1.955 | 0.8 | 1.1 |
0.9 | -0.008 | 0.780 | ||||
-0.1 | -0.008 | -0.220 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, the test item did not show an eye hazard potential. The test item is not requiring classification for eye irritation or serious eye damage (UN GHS: No Category).
- Executive summary:
After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 0.2 (study acceptance criteria range: -1,4 - 3.0). Treatment with the positive control (20% Imidazole) revealed an IVIS of 103.8 (study acceptance criteria range: 83.0 - 131.8). Therefore, the study fulfilled the acceptance criteria. The IVIS obtained after treatment with the test item was 0.8 and, thus, lower than 3, i.e. according to OECD 437 the test item is not requiring classification for eye irritation or serious eye damage (UN GHS: No Category).
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