Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 225-464-3 | CAS number: 4861-19-2
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
No additional information is available.
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 500 mg/kg bw/day
Additional information
Urea phopshate dissociates directly into urea and phosphoric acid in aqueous environment.
Urea
Large quantities of urea are formed naturally in the human body as a consequence of normal protein catabolism. Urea is shown to be essentially without toxicity in the available studies and no effects (organ weight, gross pathology, histopathology) were observed on the reproductive organs of rats and mice exposed to urea at very high dietary levels for 12 months (Fleischman et al, 1980). The level of any primary, occupational or secondary exposure to urea is likely to be insignificant compared to the quantities (20-50 g/day) produced by normal metabolism and present at high concentrations in the blood. It is therefore considered that urea is very unlikely to be a reproductive toxin and testing cannot be justified scientifically.
Diammonium hydrogenorthophosphate (containing the phosphate part like ureaphosphate)
In an OECD 422 study rats (10/sex/dose) were dosed with 250, 750 and 1500 mg/kg bw/day orally via gavage. Males were treated until termination during week 6 of treatment. Doses were administered to the females for two weeks prior to pairing, throughout pairing and gestation until Day 3 of lactation. No effects on reproduction parameters were observed up to the highest dose tested. Therefore, the NOAEL is considered to be≥1500 mg/kg bw/day.
The two-generation reproduction toxicity study (OECD Guideline 416) was waived based on the following rationale: although the standard requirement at the tonnage band of >1000 tonnes includes a two-generation reproductive toxicity study (OECD 416), the Intellegent Testing Strategy (ECHA Guidance document, Chapter R.7a: Endpoint specific guidance. Section 7.6.6) indicates that if sufficient data exist to permit a robust conclusion on reproductive toxicity then no further testing will be required. The currently available data for reproductive/developmental testing on phosphoric acid include: 1) Negative in vitro mutagenicity genotoxicity evidence (bacterial reverse mutation and in vitro Chromosomal Aberration) suggests a low potential for germ-cell mutagenicity. 2) In an oral gavage study according to OECD 422 guideline (i. e., combined Repeat Dose/Reproductive-Developmental Toxicity test), diammonium hydrogenorthophosphate was administered to rats. No resulting reproductive or developmental effects were identified, nor were overall toxicological effects seen. A No-Observed Adverse Effects Level (NOAEL) for toxicity, reproduction and developmental effects was established at >1500 mg/kg-bw/day. 3) An oral gavage study of monosodium phosphate in mice and rats, similar to OECD 414, showed no apparent effects on nidation (i. e., implantation of a fertilized egg in a uterus) or on maternal or fetal survival. There were no significant skeletal or soft tissue abnormalities relative to sham-treated controls.
Short description of key information:
Urea phopshate dissociates directly into urea and phosphoric acid in aqueous environment. Reliable data available on diammonium hydrogenorthophosphate shows a NOAEL for reproduction toxicity after oral exposure of rats of ≥1500 mg/kg bw/day. The test was performed according to OECD Guideline 422. For urea: It is considered extremely unlikely that occupational, primary or secondary exposure to urea will result in any effects on fertility as the levels of exposure will be insignificant compared to those present in the body as a result of protein catabolism.
Effects on developmental toxicity
Description of key information
Urea phopshate dissociates directly into urea and phosphoric acid in aqueous environment.
Reliable data available on diammonium hydrogenorthophosphate shows a NOAEL for reproduction toxicity after oral exposure of rats of ≥1500 mg/kg bw/day. The test was performed according to OECD Guideline 422. For the developmental toxicity/teratogenicity endpoint, read-across with monosodium phosphate, anhydrous was done based on structural similarities and as shown in the toxicokinetic assessment (as soon as phosphoric acid reaches the blood system, it hydrolysis in phosphate and therefore, cannot become systemically bio-available as such). The 10 days NOAEL for maternal and developmental toxicity, following oral (gavage) exposure, in male/female CD-1 mouse was > or = 370 mg/kg bw/day and in male/female Wistar rats was > or = 410 mg/kg bw/day. The test was performed according to a method similar to OECD Guideline 414.
No standard studies are available for urea. It is considered extremely unlikely that occupational, primary or secondary exposure to urea will result in developmental toxicity as the levels of exposure will be insignificant compared to those present in the maternal and foetal circulation as a result of protein catabolism.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 500 mg/kg bw/day
Additional information
Urea phopshate dissociated directly into urea and phosphoric acid in aqueous environment.
Urea:
Large quantities of urea are formed naturally in the human body as a consequence of normal protein catabolism. Urea is shown to be essentially without toxicity in the available studies. The level of any primary, occupational or secondary exposure to urea is likely to be insignificant compared to the quantities (20-50 g/day) produced by normal metabolism and present at high concentrations in the maternal and foetal circulation. It is therefore considered that urea is very unlikely to be a reproductive toxin and testing cannot be justified scientifically.
Diammonium hydrogenorthophosphate (containing the phosphate part like ureaphosphate)
In an OECD 422 study rats (10/sex/dose) were dosed with 250, 750 and 1500 mg/kg bw/day orally via gavage. Males were treated until termination during week 6 of treatment. Doses were administered to the females for two weeks prior to pairing, throughout pairing and gestation until Day 3 of lactation. No effects on developmental parameters were observed up to the highest dose tested. Therefore, the NOAEL is considered to be≥1500 mg/kg bw/day.
Monocalcium phosphate (containing the phosphate part like ureaphosphate)
The administration of up to 370 mg/kg (body weight) of the test material to pregnant mice for 10 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOAEL was > or = 370 mg/kg bw/day for maternal and developmental toxicity. The administration of up to 410 mg/kg (body weight) of the test material to pregnant rats for 10 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOAEL was > or = 410 mg/kg bw/day for maternal and developmental toxicity.
Justification for classification or non-classification
Based on the available data and according to the criteria laid down in the CLP Regulation, urea phosphate should not be classified for reproductive toxicity.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.