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EC number: 604-012-2 | CAS number: 137296-15-2
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Ammonium sulfate CAS N°: 7783-20-2
- Author:
- Anonymous
- Year:
- 2 004
- Bibliographic source:
- UNEP Publications: SIDS Initial Assessment Report SIAM 19, Berlin, Germany
- Report date:
- 2004
- Reference Type:
- other: unpublished data
- 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)
- Principles of method if other than guideline:
- In the OECD SIDS report, unpublished data from an OECD 422 study conducted by the The Fertilizer Institute, 2002 on diammonium phosphate is cited.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Diammonium hydrogenorthophosphate
- EC Number:
- 231-987-8
- EC Name:
- Diammonium hydrogenorthophosphate
- Cas Number:
- 7783-28-0
- Molecular formula:
- H3N.1/2H3O4P
- IUPAC Name:
- diammonium hydrogen phosphate
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material: Diammonium phosphate
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- See "any other information on material and methods incl. tables".
- Details on mating procedure:
- See "any other information on material and methods incl. tables".
- Duration of treatment / exposure:
- See "any other information on material and methods incl. tables".
- Frequency of treatment:
- See "any other information on material and methods incl. tables".
- Details on study schedule:
- see box "Any other information on material and methods incl. tables"
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Remarks:
- Low-dose group
- Dose / conc.:
- 750 mg/kg bw/day (nominal)
- Remarks:
- Mid-dose group
- Dose / conc.:
- 1 500 mg/kg bw/day (nominal)
- Remarks:
- High-dose group
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- n.a.
- Positive control:
- n.a.
Examinations
- Parental animals: Observations and examinations:
- See "any other information on material and methods incl. tables".
- Litter observations:
- See "any other information on material and methods incl. tables".
- Reproductive indices:
- See "any other information on material and methods incl. tables".
- Offspring viability indices:
- See "any other information on material and methods incl. tables".
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- A dosage dependent increase in transient post-dosing salivation was apparent, which was considered to be due to the palatability of the test formulations rather than toxicity. A dosage-dependent increase in the number of animals with reddening of the extremities was also apparent mainly during the early stages of treatment.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- No treatment-related deaths were observed.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gain and food consumption of males at 1500 mg/kg bw/day appeared to be suppressed when compared with the control group (78 % of controls during weeks 0–5). The body body weight gain for reproductive subgroup females receiving 1500 mg/kg bw/day was reduced during the first week of gestation, after which the values returned to levels comparable with the control.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gain and food consumption of males at 1500 mg/kg bw/day appeared to be suppressed when compared with the control group (78 % of controls during weeks 0–5).
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In males, a dosage-dependent reduction in total protein at 750 and 1500 mg/kg bw/day with a slightly elevated albumin/globulin ratio at the top dose was observed.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Some treatment-related effects on haematology were evident (reduction in activated partial thromboplastin time for males at 750 and 1500 mg/kg bw/day, a non-dosage-dependent elevation of alkaline phosphatase levels at 1500 mg/kg bw and 750 mg/kg bw/day, reduced glucose and phosphorous levels at 1500 mg/kg bw/day). Changes in females were limited to a decrease in phosphorous levels and a non-significant increase in alkaline phosphatase level at 1500 mg/kg bw/day.
- Endocrine findings:
- not specified
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- There were changes apparent at behavioural testing.
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- The only histological findings related to treatment were the inflammatory/degenerative stomach changes in all treated groups that were considered likely to have arisen due to an irritant effect of the test formulations.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Mating performance and fertility were unaffected by treatment. For details please refer to box "details on results (P0)".
Details on results (P0)
Females achieving pregnancy: n = 9, 10, 10, 10
Dams with live young born: n = 9, 10, 10, 10
Implants/dam (mean): 15.7, 15.7, 14.1, 15.4
There were no effects on the time to achieve conception, and pregnancy length.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse signs of toxicity were observed in the low dose
- Dose descriptor:
- LOAEL
- Effect level:
- 750 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No adverse effects observed.
- Histopathological findings:
- not specified
- Other effects:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Details on results (F1)
Summary of effects (control, low, mid and high dose):
Live pups/dam at birth (mean): 14.8, 14.6, 12.7, 14.0
Live pups/dam at day 4 (mean): 14.6, 14.3, 12.7, 14.0
sex ratio (% m) at birth (mean): 54.2, 52.7, 50.0, 48.5
sex ratio (% m) at day 4 (mean): 54.2, 53.0, 50.0, 48.5
Male pup weight at birth (mean): 6.4, 6.3, 6.6, 6.3
Male pup weight at day 4 (mean): 8.7, 8.5, 9.2, 8.7
Female pup weight at birth: 5.9, 6.0, 6.1, 6.0
Female pup weight at day 4: 8.2, 7.9, 8.6, 8.4
Post-implantation survival index: 95.2, 93.5, 90.0, 94.8
Live birth index: 99.3, 99.4, 100.0, 95.9
Viability index: 98.6, 98.2, 100.0, 100.0
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed at the high dose
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In a repeated dose toxicity study combined with the reproduction/developmental toxicity screening test (OECD 422), the test item diammonium phosphate was administered to male and female CD rats by gavage at dose levels of 0, 250, 750 and 1500 mg/kg bw/day. The NOAEL for parental toxicity was determined to be 250 mg/kg bw/day. No adverse effects were seen on any reproductive or developmental toxicity parameters. Thus, the NOAEL for reproductive/developmental toxicity can be considered to be 1500 mg/kg bw/day.
- Executive summary:
In a repeated dose toxicity study combined with the reproduction/developmental toxicity screening test (OECD 422), the test item diammonium phosphate was administered to male and female CD rats (10 females and 5 males/dose group) by gavage at dose levels of 0, 250, 750 and 1500 mg/kg bw/day. Animals were paired 2 weeks after start of treatment. No mortality occurred. Some treatment-related effects on haematology parameters at 1500 and 750 mg/kg bw were evident, and body weight gain was temporarily reduced in the high dose group. Offspring was unaffected by parental exposure. Viability up to day 4 post-partum and macroscopic necropsy showed no effect on the pups. Based on the results, the maternal NOAEL is considered to be 250 mg/kg bw and the NOAEL for reproductive/developmental toxicity is considered to be 1500 mg/kg bw/day.
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