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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 12, 1994 - July 15, 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- 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
- Test material form:
- solid: particulate/powder
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Conelli s.n.c
- Age at study initiation: 2-3 months
- Weight at study initiation: 2-3 kg
- Housing: individual caging in T06C air conditioned room. Each rabbit was caged in metal cages 62x47x48h cm with stainless feeder.
- Diet (e.g. ad libitum): ad libitum (GLP 2 RB 15 certificate pelleted diet)
- Water (e.g. ad libitum): ad libitum (from the municipal water main system, filtered).
- Acclimation period: about 3 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 (artificial lighting)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/animal - Duration of treatment / exposure:
- 3 minutes, 1 and 4 hours
- Observation period:
- Immediately after 3 minute and the 1 hour-exposure period and at 72 hours in the first rabbit and at 1, 24, 48 and 72 hours after the 4-hour exposure period (all rabbits).
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: covered with a gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape.
SCORING SYSTEM:
Erythema and Eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Edema formation:
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate edema (raised approximately 1 mm): 3
Severe erythema (raised more than 1 mm and extending beyond area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema 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
Observation of clinical signs and behaviour: No clinical signs or behavioural alterations were noted.
Skin evaluation: At the application sites no signs of dermal irritancy were evident in any treated rabbit.
Table 1. Dermal reactions (individual).
Animal no. 135M. |
Observation at |
Exposure period |
|
3 min |
1 h |
||
1) Erythema and eschar |
3 min |
0 |
- |
1 h |
0 |
0 |
|
72 h |
0 |
0 |
|
2) Edema |
3 min |
0 |
- |
1 h |
0 |
0 |
|
72 h |
0 |
0 |
Table 2. Dermal reactions (individual).
Exposure period: 4h |
Observation at |
No. of animals |
||
135M |
136M |
137M |
||
1) Erythema and eschar |
60 min |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
2) Edema |
60 min |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria.
- Conclusions:
- The acute dermal irritation study in New Zealand White rabbits treated with a single administration of test article Fosfomycin PEA salt (0.5 g/animal) has to be considered "non irritant" for the skin.
- Executive summary:
The acute dermal irritation study in New Zealand White rabbits treated with a single administration of test article Fosfomycin PEA salt (0.5 g/animal) followed the EU Method B.4 and the OECD Guideline 404. 3 rabbits were used in the study. On the first one the test article was applied for an exposure period of 3 minutes and 1 hour with observation periods of 3 minutes and 1, 24, 48 and 72 hours. The three rabbits were exposed to the test article for 4 hours and observed at periods of 1, 24, 48 and 72 hours. The application areas were covered and the adjacent areas of untreated skin of each animal served as control for the test.
No untoward clinical signs or behavioural alterations were observed.
At the application site, no signs dermal irritancy were observed in any treated rabbit.
The test article Fosfomycin PEA salt, when administered by dermal route to rabbits under the experimental conditions adopted, has to be considered "NON IRRITANT" for the skin.
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