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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Older published, public domain material. Not a standard test.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of Atmospheric Ammonia on the Pig
- Author:
- Stombaugh, D.P., Teague, H.S. and Roller, W.l.
- Year:
- 1 969
- Bibliographic source:
- J. Anim. Sci. 28(6), 844-847
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of the effects of ammonia exposure in pigs
- GLP compliance:
- no
- Remarks:
- : published study, predates GLP
- Limit test:
- no
Test material
- Reference substance name:
- Ammonia, anhydrous
- EC Number:
- 231-635-3
- EC Name:
- Ammonia, anhydrous
- Cas Number:
- 7664-41-7
- Molecular formula:
- H3N
- IUPAC Name:
- ammonia
- Details on test material:
- No further details
Constituent 1
Test animals
- Species:
- pig
- Strain:
- other: Duroc
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Two trials were performed. Thirty six Duroc pigs with an average initial weight of 45.3 kg were used in trial 1 and the average initial weight of the 36 pigs in trial 2 was 62.5 kg. Animals were placed in four 2.7 x 4.9 m compartments each possessing its own air tempering unit which maintained a dry bulb temperature of 21.2 ⁰C and a relative humidity of 77% throughout the trials. The pen floors were poured concrete and were cleaned daily to prevent any appreciable increase of ammonia or other gases from waste decomposition.
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Ammonia was introduced into three of the four compartments in the supply air ducts. To control introduction, a corrosion resistant pressure regulating valve was mounted on the bulk tank.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Ammonia levels were measured daily using the standard technique described by Goldman and Jacobs (1953). The method consists of bubbling a known quantity of air through dilute sulfiuric acid and back titrating with dilute sodim hydroxide.
- Duration of treatment / exposure:
- 5 week period, continuous exposure to the ammonia levels.
- Frequency of treatment:
- Continuous exposure to ammonia
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Concentrations ranging from 31-150 ppm.
Basis:
analytical conc.
- No. of animals per sex per dose:
- There were 36 animals in trial 1 and 36 animals in trial 2. The sex of the animals is unknown.
- Control animals:
- no
- Details on study design:
- Four groups of pigs in each of the two trials were exposed for a 5-week period to ammonia concentrations of approximately 10, 50 , 100 and 150 ppm. Response criteria were feed consumption, growth rate, feed efficiency and results of gross microscopic and bacteriological examination of the respiratory tract. Pigs were weighed at weekly intervals and feed consumption was determined on Monday, wednesday and Friday of each week. At the end of the experimental period, three animals were selected from each compartment of trial 1 and two from each compartment in trial 2 for autopsy.
- Positive control:
- No positive control
Examinations
- Observations and examinations performed and frequency:
- Pigs were weighed at weekly intervals and feed consumption was determined on Monday, wednesday and Friday of each week. At the end of the experimental period, three animals were selected from each compartment of trial 1 and two from each compartment in trial 2 for autopsy. The bronchi, lungs and turbinates were examined grossly and tissues from the mid-portion of the ventral turbinate and the cardiac or anterior part of the diaphragmatic lobe of the lung were examined microscopically.
- Sacrifice and pathology:
- At the end of the experimental period, three animals were selected from each compartment of trial 1 and two from each compartment in trial 2 for autopsy. The bronchi, lungs and turbinates were examined grossly and tissues from the mid-portion of the ventral turbinate and the cardiac or anterior part of the diaphragmatic lobe of the lung were examined microscopically.
- Other examinations:
- No further examination
- Statistics:
- None
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Ammonia concentration had a highly significant adverse effect upon feed consumption and average daily weight gain. However, there was no significant effect upon efficiency of food conversion. During both trials the high ammonia levels appeared to cause excessive nasal, lacrimal and mouth secretions. This was more pronounced at 100 and 150 ppm than at 50 ppm. Autopsies carried out on three animals showed no significant gross or microscopic differences related to ammonia level. Cultures of Corynebacterium and Pasteurella were obtained from swabs of the ethmoid turbinates from two animals removed from the compartment maintained at 150 ppm and one animal maintained at 100 ppm. There was no evidence of these bacteria in turbinate swabs from other animals.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- 5 weeks
- Effect level:
- 61 ppm
- Sex:
- not specified
- Dose descriptor:
- LOEL
- Remarks:
- 5 weeks
- Effect level:
- 103 ppm
- Sex:
- not specified
- Basis for effect level:
- other: coughing and nasal, lacrimal and oral secretions
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Other noticable differences in the pigs included increased coughing. A measure of the frequency of the coughing obtained by recording the number of coughs heard while weighing the pigs in each pen revealed that at the higher ammonia concentration (100 and 150 ppm) pigs coughed approximately three times as much as those in the other two compartments. At 50 ppm the frequency of coughing was slightly greater than at the more natural level of ammonia (10 ppm).
Applicant's summary and conclusion
- Conclusions:
- Ammonia concentrations had a highly significant adverse effect upon food consumption and average daily gain. However, there was no significant effect upon efficiency of feed conversion. Frequency of coughing was increased when the animals were exposed to higher levels of ammonia. Also cultures of Corynebacterium and Pasteurella were obtained from swabs of the ethmoid turbinates from two animals removed from the compartment maintained at 150 ppm and one animal maintained at 100 ppm. There was no evidence of these bacteria in turbinate swabs from other animals.
- Executive summary:
Ammonia concentrations had a highly significant adverse effect upon feed consumption and average daily weight gain. However, there was no significant effect upon efficiency of food conversion. During both trials the high ammonia levels appeared to cause excessive nasal, lacrimal and mouth secretions. This was more pronounced at 100 and 150 ppm than at 50 ppm. Autopsies carried out on three animals showed no significant gross or microscopic differences related to ammonia level. Cultures of Corynebacterium and Pasteurella were obtained from swabs of the ethmoid turbinates from two animals removed from the compartment maintained at 150 ppm and one animal maintained at 100 ppm. There was no evidence of these bacteria in turbinate swabs from other animals.
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.