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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 938-988-9 | CAS number: -
- 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
The submission substance consists of naturally occuring components of generally low toxicity. Evaluation of oral exposure to phosphorous compounds by various international bodies (JECFA, EFSA) yielded a maximum tolerable daily intake) of 70 mg P/kg bw/day.
A combined repeated dose - reproductive / developmental toxicity screening test according to OECD 422 with the related substance triple superphosphate (TSP) resulted in a NOAEL of 250 mg/kg bw/day. A similar study with Ca sulfate dihydrate revealed a NOAEL of 79 mg/kg bw/day.
Contributions of of the ligand humate to the overall toxicity of the submission substance are considered to be small due to the small contribution (<1% on w/w basis).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- good
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Phosphate:
In a combined repeated dose - reproductive / developmental toxicity screening test according to OECD 422 (Dent 2002) (GLP, RL1) triple superphosphate (TSP) was administered to Sprague-Dawley rats orally (gavage). Animals were either exposed for 6 weeks (males and females of toxicity subgroup) or 2 weeks before mating, during mating and gestation until postnatal day 3 at doses of 0, 250, 750 or 1500 mg/kg bw/day (doses are calculated as TSP added to feed, natural phosphate in feed not counted). Several haematological and clinical chemistry parameters were changed at the two highest dose levels and neurobehavioural changes were observed at the highest dose. Minimal kidney and stomach effects observed at the lowest dose administered were not considered adverse or caused by a locally irritating effect, respectively.
No effects on reproductive parameters or developmental toxicity were observed other than slight reductions in pup body weights at the highest dose level. Therefore, a NOAEL of 250 mg/kg bw/day for repeated dose toxicity was derived from this study performed with TSP.
In an older, but reliable (RL2) published study (Dymsza et al., 1959) normal and high levels of phosphorous (0.43 and 1.3% P) in the form of ortho- (dibasic potassium phosphate) or metaphosphate (Na hexamethphosphate) were fed to male rats over 150 days. Neither the types nor the levels of phosphates impaired growth conclusively as measured by weight geined and femur length. No adverse physiological effects were observed from autopsy, histological and clinical studies. There appeared to be adequate absorption and utilization of calcium, phosphorous and iron with any of the tested diets. The study is not as detailed and comprise fewer investigations compared to current guideline studies, but focuses on potential deleterious effects of phosphate, and includes histopathological examination of the target organ kidney (examination of nephrocalcinosis). Therefore it is considered reliable with respect to the evaluation of phosphates. The NOAEL from this subchronic feeding study is 1.3% P in food, which translates to (ECHA Guidance on IR and CSA, R.8) to 520 mg/kg day for male rats.
Several reviews are available which summarise the results of various older (years 1950 to 1975) feeding studies with various phosphate compounds (JECFA 1982, Weiner et al. 2001; Lang 1959). Very high levels of phosphate in feed may cause an increase of plasma phosphorus and a decrease in serum calcium. In consequence, hypocalcaemia, bone resorption and loss and calcification of soft tissues may occur, especially in the kidney. In rats nephrocalcinosis was observed at high phosphate concentrations in the diet. A LOAEL of 10000 mg P/kg diet was derived by JECFA from studies with rats, which are - according to JECFA - especially susceptible to tissue calcification. A MTDI (maximum tolerable daily intake) of 70 mg P/kg bw/day was established for the intake by humans of phosphates from food.
Humic acid potassium salt:
The substance was tested for subacute toxicity using the EU method B.7.Repeated Dose (28-days) Toxicity (Oral), study with Wistar rats. The test substance was administered as solution in water by stomach tube; oral application of rats was made daily. The study includes four main groups and two satellite groups of animals. Each main group consisted of 5 males and 5 females; each satellite group consisted of 5 males and 5 females.Main groups contained 3 treated groups (doses 250, 500, 1000 mg/kg of body weight /day) and one control group (vehicle only). The satellite groups contained one control group (vehicle only) and one treated group (1000 mg/kg/day). The administration period lasted 28 days.
Based on slightly reduced body weights and changes in values of haematological and biochemical parameters detected at the hightest dose level a NOAEL of 500 mg/kg bw/day was derived.
Several published studies on the repeated dose toxicity of humic acids or humate salts are available. Two subchronic oral studies did not observe advese effects up to levels of 1000 mg/L drinking water (Daniel 1991; Condie 1985). One study of low reliability reported slight effects on the thyroid gland (Seffner 1985).
Calcium sulfate:
Calcium and sulfate are natural constituents of food and essential food components. It is of limited water solubility.
Calcium sulfate as an food addtive has been evaluated by the EU Commission's Scientific Committee on Food (SCF) and the FAO/WHO Joint Expert Committee on Food Additives (JECFA). These committees allocated an Acceptable Daily Intake (ADI) not specified for the respective calcium and sulfate ions, due to its non-toxicity after oral exposure. It is generally permitted in the EU and the USA as an approved food additive (EU: E516). The European Food Safety Agency EFSA (2008) evaluated the use of Calcium sulfate in food supplements as a source of calcium based on the tolerable upper intake level of 2500 mg calcium/day as established by SCF. EFSA concluded that calcium sulfate as a source of calcium in food supplements is of no safety concern. Similarly, in 2004 EFSA concluded that its use as a mineral substance in food is of no safety concern. Any contribution to the overall exposure from handling the submission substance is considered to be low compared to exposure from food.
Calcium sulfate dihydrate was tested in a combined repeated dose/reproductive toxicity screening test according to OECD Guideline 422. The test material was administered to male and female Sprague Dawley rats by gavage at daily doses of 0, 100, 300 and 1000 mg/kg bw/day. The NOAEL for calcium sulfate anhydrous was 79 mg/kg/day for males based on a significant decrease in TP (Total Protein), ALB (Albumin), BUN (Blood Urea Nitrogen), and CREA (Creatinine) at the 300 mg/kg b.w./day and 1,000 mg/kg b.w./day groups. No effects were observed in females.
Justification for classification or non-classification
The main components of the submission substance are naturally occuring substances of generally low toxicity. LOAELs from repeated dose toxicity studies are well above the classification criterion of 10 mg/kg bw/day for oral studies. No classification is required.
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.