Registration Dossier
Registration Dossier
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: 213-911-5 | CAS number: 1066-33-7
- 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:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles; Data taken from EU risk assessment/SIDS
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Tributyl Phosphate Effects on Urine and Bladder Epithelium in Male Sprague-Dawley Rats
- Author:
- Arnold L.L. et al.
- Year:
- 1 997
- Bibliographic source:
- Fund. Appl. Toxicol. 40, 1997
- Reference Type:
- publication
- Title:
- OECD SIDS Ammonium Chloride, Final 8/2006
- Author:
- OECD
- Year:
- 2 006
- Bibliographic source:
- OECD SIDS AMMONIUM CHLORIDE
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In this subchronic feeding study, ten male Sprague-Dawley received 12300 ppm ammonium chloride (equivalent to 684 mg/kg bw/day) continuously via diet for 70 days.
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Ammonium chloride
- EC Number:
- 235-186-4
- EC Name:
- Ammonium chloride
- Cas Number:
- 12125-02-9
- IUPAC Name:
- ammonium chloride
- Details on test material:
- - Name of test material (as cited in study report): Ammonium chloride
- Supplier: Sigma Chemical
- Analytical purity: > 98.7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories Inc. (Kingston NY)
- Age at study initiation: 4 - 5 weeks
- Weight at study initiation: mean 175 g
- Housing: individually in suspended stainless steel wire-mesh cages
- Diet (e.g. ad libitum): Purina Mills Certified Rodent Lab Chow, St. Louis, MO); ad libitum
- Water (e.g. ad libitum): water; ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-4
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The ammonium chloride content in the diet was determined by photometric analysis following extraction of chloride from feed using boiling water. The water/chloride extract was analyzed with a COBAS MIRA Plus Chemistry System (Roche Diagnostic System, Inc.)
- Duration of treatment / exposure:
- 70 days
- Frequency of treatment:
- continously by feed
Doses / concentrations
- Remarks:
- Doses / Concentrations:
12300 ppm in the diet (equivalent to 684 mg/kg bw/day)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Post-exposure recovery period: 7 days
- Positive control:
- Tributyl phosphate (TBP): 0, 3000 ppm (including 10 week recovery period)
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: Yes
- Time schedule for collection of urine: after each week
- Metabolism cages used for collection of urine: No
- Animals fasted: No data
- Parameters examined: pH, osmolality, Magnesium, Calcium, Creatinine, Phosphate, Protein
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes: bladder, kidney
HISTOPATHOLOGY: Yes: bladder, kidney
Results and discussion
Results of examinations
- Details on results:
- BODY WEIGHT
No significant difference between ammonium chloride treatment and control. Significantly decreased in the TBP treatment group.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
No significant difference among any of the groups (ammonium chloride, TBP and control); mean 110 g/kg b.w./day (initial) to 55.6 g/kg b.w./day (final)
URINALYSIS
- pH: ammonium chloride treatment reduced urinary pH to 6.04 (control: 7.56)
-Calcium: significantly increased in the ammonium chloride treatment. However the crystals from urine were not found.
ORGAN WEIGHTS
No significant difference compared to control
HISTOPATHOLOGY:
No abnormalities found.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 12 300 ppm
- Sex:
- male
- Basis for effect level:
- other: no adverse effects noted
- Dose descriptor:
- NOAEL
- Effect level:
- 684 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: no adverse effects noted
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Effects on urinary chemistry:
pH | Magnesium (mEq/l) | Osmolality (mOs/kg bw) | Calcium (mg/dl) | Creatinine (mg/dl) | Phosphate (mg/dl) | Protein (mg/dl) | |
NH4Cl | 6.04 ± 0.10* | 42.8 ± 11.3 | 1305 ± 156 | 11.0 ± 1.4* | 52 ± 5+ | 51 ± 9 | 108 ± 24 |
3000 ppm TBP | 7.61 ± 0.05 | 37.6 ± 3.1 | 1034 ± 58* | 4.5 ± 0.5 | 60 ± 4* | 37 ± 11 | 119 ± 12 |
Control | 7.56 ± 0.07 | 48.9 ± 5.1 | 1395 ± 87 | 5.9 ± 0.6 | 80 ± 5 | 41 ± 6 | 117 ± 11 |
* p<0.05
Histopathological effects on the bladder:
Bladder weight | Bladder histology | |||||
g | g/kg bw | normal | simple hyperplasia | papillary/nodular hyperplasia | BrdU labeling index | |
NH4Cl | 0.138 ± 0.008 | 0.260 ± 0.014 | 10 | 0 | 0 | 0.17 ± 0.03 |
3000 ppm TBP | 0.218 ± 0.027* | 0.446 ± 0.052* | 0 | 10* | 6* | 1.81 ± 0.30 |
Control | 0.124 ± 0.010 | 0.227 ± 0.016 | 10 | 0 | 0 | 0.20 ± 0.03 |
* p<0.05
Applicant's summary and conclusion
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.
