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Toxicological information

Repeated dose toxicity: inhalation

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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:
1969
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

Constituent 1
Chemical structure
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

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.