Registration Dossier
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EC number: 234-682-8 | CAS number: 12023-53-9
- 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

Endpoint summary
Administrative data
Description of key information
Skin corrosion (in-vitro, Epiderm): Not corrosive.
Skin irritation (in-vitro, Episkin): Not irritating.
Eye irritation (in-vivo): Not irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 December 2011 - 22 December 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in compliance with EC, OECD, EPA, and Japanese test guidelines, and in compliance with GLP.
- Qualifier:
- according to
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.
- Deviations:
- no
- GLP compliance:
- yes (incl. certificate)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 44 to 47 weeks
- Weight at study initiation: 3.98 to 4.52 kg
- Housing: Housed individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): Ad libitum access to standard laboratory diet.
- Water (e.g. ad libitum): Ad libitum access to drinking water.
- Acclimation period: At least 25 weeks.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 20°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark.
IN-LIFE DATES: From: To: - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: No dedicated control animals were used; in each animal the right eye was treated; the left eye remained untreated.
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Not applicable. A single intillation of the test material was made; eyelids were held together for one second before releasing.
- Observation period (in vivo):
- 72 hours; observations were made 1, 24, 48, and 72 hours after treatment.
- Number of animals or in vitro replicates:
- Three females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM: Consistent with the system described in the EU test method (Commision regulation 440/2008, Part B, method B5).
TOOL USED TO ASSESS SCORE: An opthalmoscope or pencil beam torch was available. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- Injection of the conjunctival blood vessels was apparent in one animal one hour after instillation; no reaction to treatment was evident in the other animals. The treated eyes of all animals were overtly normal 24 hours after instillation
Instillation of the test substance gave rise to practically no initial pain response. - Other effects:
- There was no sign of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The highest total mean score was 2.0 occurring at the one hour observation; accordingly under the criteria Kay and Calandra (1962) Ferrophosphorus (Fe3P) was classified as “practically non-irritating” to the eye. Ferrophosphorus (Fe3P) did not require labelling in accordance with European Commission regulation 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two in-vitro tests were conducted to assess the effect of exposure of Fe3P to the skin. An Epiderm study (Huntingdon Life Sciences, 2010, study number FGE0004) assessed the potential corrosivity of the test material, whereas an Episkin study (Huntingdon Life Sciences, 2011, study number FGE0018) was performed to assess potential skin irritancy. Both studies were conducted according to official OECD test guidelines and in compliance with GLP. The overall conclusion of the two studies was that Fe3P shows no evidence of skin irritation or skin corrosion. On the basis of these two studies, it was concluded that an in-vitro test was not necessary.
An in-vitro study (Bovine Corneal Opacity and Permeability, BCOP, Huntingdon Life Sciences, 2011, study number FGE0017) was conducted to asess the eye irritant potential of Fe3P. The BCOP test was negative (did not indicate any potential to cause eye irritation), but this result alone was not considered sufficient to reach a definitive conclusion on the eye irritant properties of Fe3P, and so an in-vivo test was conducted (Huntingdon Life Sciences, 2012, study number FGE0019). Both studies were conducted according to official test guidelines (OECD and / or EC) and in compliance with GLP. Mild conjunctival redness was seen in one rabbit (out of three) one hour after instillation, but this was fully resolved by the 24-hour observation timepoint, and all treated animals' eyes were considered overtly normal from the 24-hour timepoint onwards. It was concluded that Fe3P is not an eye irritant.
Justification for selection of skin irritation / corrosion endpoint:
Note that no single study has been selected, as the conclusion as "not corrosive and not irritating" is based on the results of two in-vitro tests (Episkin and Epiderm).
Justification for selection of eye irritation endpoint:
The in-vivo eye irritation test was selected as the Key study as in-vivo data is considered more reliable than in-vitro data.
Justification for classification or non-classification
Fe3P did not demonstrate any irritant properties in any of the skin or eye irritation studies conducted. On this basis it is concluded that Fe3P does not meet the criteria for classification as a skin or eye irritant under either the Classification, Labelling and Packaging (CLP) Regulation, nor under the Dangerous Substances Directive.
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