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EC number: 231-635-3 | CAS number: 7664-41-7
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP compliant proprietary study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Diammonium phosphate
- IUPAC Name:
- Diammonium phosphate
- Reference substance name:
- Diammonium hydrogenorthophosphate
- EC Number:
- 231-987-8
- EC Name:
- Diammonium hydrogenorthophosphate
- Cas Number:
- 7783-28-0
- IUPAC Name:
- diammonium hydrogen phosphate
- Details on test material:
- Diammonium phosphate (DAP), 17.93% NH4 and 46.86% P2O5 equivalent.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Crl:CD(SD)IGS BR rats
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: water purified by reverse osmosis
- Details on oral exposure:
- The substance was administered daily via gavage.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No information
- Duration of treatment / exposure:
- The exposure period for the toxicity subgroup was 35 days, while the exposure period for the reproductive subgroup was at most 28 days among male and 53 days among females.
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 750 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- There were 5 males and 5 females per dose group in the toxicity group, and 5 males and 10 females per dose in the reproductive toxicity group.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Doses were selected based on parameters assessed in a range-finding study at concentrations up to 1,000 mg/kg/day.
Animals comprising the toxicity subgroup (5 males and 5 females per dose group) were administered Diammonium Phosphate (DAP) for 5 weeks (7 days/week) via gavage administration. Animals comprising the reproductive subgroup (5 males and 10 females) were administered DAP for a period encompassing approximately 53 continuous days via oral gavage: 14 days of initial treatment, plus a maximum of 14 days of cohabitation to ensure mating, and among females, at least 25 days to litter and rear their young until day 4 of age. - Positive control:
- Not required for this study type.
Examinations
- Observations and examinations performed and frequency:
- Toxicity subgroup:
Functional observations (sensory reactivity, grip strength, motor activity) and bleeds for haematology and blood chemistry were conducted during week 5 of treatment (see below).
Histology for reproductive subgroup animals was restricted to retained reproductive organs (and any other abnormalities observed at necropsy). - Sacrifice and pathology:
- In the toxicity subgroup: organ weights (adrenals, brain, epididymides, heart, kidney, liver, ovaries, pituitary, prostate, seminal vesicles, spleen, testes, thymus, thyroids (with parathyroids) and uterus with cervix) were recorded at termination during Week 6. The following organs and tissues (and any other abnormalities observed at necropsy) were processed for microscopic examination: adrenals, aorta, brain, caecum, colon, duodenum, epididymides, eyes, heart, ileum, jejunum, kidneys, liver, lungs, lymph nodes, mammary area, oesophagus, ovaries, pancreas, pituitary, prostate, rectum, salivary glands, sciatic nerves, seminal vesicles, skin, spinal cord, spleen, sternum (bone marrow), stomach, testes, thymus, thyroid, trachea, urinary bladder, uterus and vagina.
- Other examinations:
- No information
- Statistics:
- No information
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Toxicity subgroup:
There were no treatment-related deaths and no signs of overt clinical toxicity. Bodyweight gain and food consumption appeared to be suppressed among males at 1,500 mg/kg/day (bw 78% of control). The only treatment-related change evident in haematology was a reduction in activated partial thromboplastin time for males at 750 or 1,500 mg/kg/day (74 and 76% of control, resp.). There was a slightly greater variability in blood chemistry parameters, and the following were blood chemistry changes for males that may represent an effect of treatment: a non dosage-dependant elevation of alkaline phosphatase levels at 750 and 1,500 mg/kg/day (132 and 131% of control, resp.); reduced glucose and phosphorous levels at 1,500 mg/kg/day (79 and 82% of control, resp.); a dosage-dependant reduction in total protein at 750 and 1,500 mg/kg/day (93 and 91% of control, resp.) with a slightly elevated albumin/globulin ratio at the high dose (117% of control). Changes in females were limited to a decrease in phosphorous levels and a non-significant increase in alkaline phosphatase levels at 1,500 mg/kg/day (81 and 122% of control, resp.). No effect was observed on functional observations. Reddening of the extremities during the first week of dosing was observed in all doses, including 250 mg/kg/day but reduced as the treatment period progressed. Histological examination of the stomachs revealed some submucosal inflammation at all doses (0/5, 3/5, 4/5 and 2/5 for males and 0/5, 2/5, 4/5 and 4/5 for females at 0, 250, 750 and 1500 mg/kg bw), but this change was not dose dependent and was not statistically significant at the low dose.
Reproductive subgroup: There were no treatment-related deaths and no signs of overt clinical toxicity. Bodyweight gain for reproductive subgroup females receiving 1,500 mg/kg/day was reduced during the first week of gestation (82% of control), after which they returned to levels comparable to the controls for the remainder of the study. Mating performance and fertility were unaffected by treatment, and parental treatment had no apparent effect on the offspring to day 4 of age.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: General toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Reproduction/developmental toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 750 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: General toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- > 1 500 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Reproduction/developmental toxicity
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
NOAEL: 250 mg/kg/day (general toxicity); 1,500 mg/kg/day (reproduction/developmental toxicity)
LOAEL: 750 mg/kg/day (general toxicity); >1,500 mg/kg/day (reproduction/developmental toxicity)
Applicant's summary and conclusion
- Conclusions:
- Diammonium phosphate NOAEL: 250 mg/kg/day (general toxicity); 1,500 mg/kg/day (reproduction/developmental toxicity)
Diammonium phosphate LOAEL: 750 mg/kg/day (general toxicity); >1,500 mg/kg/day (reproduction/developmental toxicity) - Executive summary:
The toxicity of diammonium phosphate (DAP) was assessed in a combined repeated dose toxicity study with a reproduction / developmental toxicity screening test in rats. The NOAEL was found to be: 250 mg/kg/day (general toxicity); 1,500 mg/kg/day (reproduction/developmental toxicity). The LOAEL was found to be: 750 mg/kg/day (general toxicity); >1,500 mg/kg/day (reproduction/developmental toxicity)
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.
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