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EC number: 418-570-8 | CAS number: 25383-07-7
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 21, 1994 - July 25, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
- EC Number:
- 418-570-8
- EC Name:
- (R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
- Cas Number:
- 25383-07-7
- Molecular formula:
- C11H20NO5P
- IUPAC Name:
- (R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
- Details on test material:
- - Name of test material (as cited in study report): Fosfomycin PEA salt
- Physical state: white crystalline powder
- Lot/batch No.: 4177
- Expiration date of the lot/batch: at least 3 years from the manufacturing date
- Stability under test conditions: at least 3 years
- Storage condition of test material: plastic bag in a cartboard box, at room temperature protected from the light
- Other: manufacturing date: june 10, 1994
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Conelli s.n.c
- Age at study initiation: 2-3 months
- Weight at study initiation: 2.0-3.0 kg
- Housing: individual caging in T06C air conditioned rooms. Each rabbit was caged in metal caged measuring 62x47.5x38h cm with stainless feeder.
- Diet (e.g. ad libitum): Ad libitum (GLP 2RB15 certificate pelleted diet)
- Water (e.g. ad libitum): Ad libitum (from the municipal water main system, filtered)
- Acclimation period: about 4 months
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 ºC
- Humidity (%):50 ± 15 %
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light (7 a.m. - 7 p.m.)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g/animal - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- at 1, 24, 48 and 72 h after the test article application.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, the eyes of the test animals were washed out
- Time after start of exposure: 24 h
SCORING SYSTEM:
CORNEA:
Opacity: degree of density (most dense are taken for reading):
No ulceration or opacity: 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible: 1
Easily discernible translucent area, details of iris slightly obscured: 2
Nacrous area, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4
IRIS:
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combinations of any thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, hemorrhage, gross destruction (any or all of these): 2
CONJUNCTIVAE:
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris):
Blood vessels normal: 0
Some blood vessels definitely hyperemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
Chemosis: lids and/or nictating membranes:
No swelling: 0
Any swelling above normal (includes nictating membranes): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: After the 24-hour reading, corneal epithelium defects were examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Mortality: No animals died during the observation period.
Observation of clinical signs and behaviour: No clinical signs or behavioural alterations were noted in any treated rabbit.
Eye evaluation:
Slight lacrimation was noted only one hour after the test article application in all rabbits.
Eye reaction (individual) |
Observation made at: |
No. of animals |
||
135M |
136M |
137M |
||
CORNEA |
60 mins. |
0 |
0 |
0 |
24 hrs |
0 |
0 |
0 |
|
48 hrs |
0 |
0 |
0 |
|
72 hrs |
0 |
0 |
0 |
|
IRIS |
60 mins. |
0 |
0 |
0 |
24 hrs |
0 |
0 |
0 |
|
48 hrs |
0 |
0 |
0 |
|
72 hrs |
0 |
0 |
0 |
|
CONJUNCTIVAE Redness |
60 mins. |
1 |
1 |
1 |
24 hrs |
1 |
0 |
0 |
|
48 hrs |
0 |
0 |
0 |
|
72 hrs |
0 |
0 |
0 |
|
CONJUNCTIVAE Chemosis |
60 mins. |
1 |
0 |
1 |
24 hrs |
0 |
0 |
0 |
|
48 hrs |
0 |
0 |
0 |
|
72 hrs |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria.
- Conclusions:
- The acute eye irritation study in New Zealand White rabbits treated with a single administration of test article Fosfomycin PEA salt (0.1 g/animal) has to be considered "non irritant" for the eye.
- Executive summary:
The acute eye irritation study in New Zealand White rabbits treated with a single administration of test article Fosfomycin PEA salt followed the OECD Guideline 405. 3 rabbits were used in the study. The test article (0.1 g) was placed in the conjunctival sac of the right eye of each animal for 24 hours. The other eye (left), remaining untreated, served as control. Clinical observations of cornea, iris, conjunctivae and chemosis were made at 1, 24, 48 and 72 hours after the test article application. After the 24 -hours reading, corneal epithelium defects were examined.
No animals died during the study.
No general clinical signs were seen in any animal.
At the application site, slight reversible irritative ocular changes were observed in all treated rabbits. No signs were evident 48 hours after the test article application in any animal.
In conclusion, the test article Fosfomycin PEA salt, when administered by ocular route to rabbits under the experimental conditions adopted, has to be considered "NON IRRITANT" for the eye.
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