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Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published study
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Acute inhalation toxicity study of ammonia in rats with variable exposure periods.
Author:
Appelman, L.M., Ten Berge, W.F. and Reuzel, P.G.J.
Year:
1982
Bibliographic source:
Am. Ind. Hyg. Assoc. J; 43(9), 1982, 662-665.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Assessment of acute inhalation toxicity in the rat following various exposure periods
GLP compliance:
not specified
Remarks:
: published study
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:
Liquid ammonia (UKF-SBB, Geleen, The Netherlands), supplied in a pressurised container.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Groups of male and female SPF-bred Wistar rats (Cpb:WU, Wistar Random), obtained from the Central Institute for the Breeding of Laboratory Animals, TNO, Zeist. The average age of the rats on arrival was 7-8 weeks, and the body weights of males and females varied between 150-170 g, and 130-140 g, respectively. After exposure rats were housed 5 per cage for the 14 day observation period. Food (standard laboratory rat diet) and tap water were available during the observation period, but were witheld during exposure. The temperature and relative humidity of the room were maintained at 21±1°C and 50-60%, respectively.

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Groups of male and female rats were exposed to dynamic atmospheres containing different concentrations of ammonia for 10, 20, 40 or 60 mins. The atmosphere was an ammonia/air mixture, introduced at a rate of 25 L/min.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
by titration
Duration of exposure:
10 - 60 min
Concentrations:
Various exposure concentrations were used to establish the LC50 value for ammonia at 10, 20, 40 or 60 mins. Actual range of concentrations used not noted.
No. of animals per sex per dose:
5 males and 5 females per group
Control animals:
no
Details on study design:
Groups of female and male rats were exposed to dynamic atmospheres containing different concentrations of ammonia for 10, 20, 40 or 60 mins. The aim of the study was to establish the relationship between exposure concentration and exposure period and mortality. Following exposure rats observed for clinical signs for 14 days. Body weight was recorded at days 1, 2, 4, 7, and 14. Clinical symptoms were recorded, and autopsy was performed after the 14 day observation period.
Statistics:
Probit method used to calculate LC50 values

Results and discussion

Preliminary study:
A preliminary study was not reported
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
28 130 mg/m³ air
95% CL:
26 040 - 30 380
Exp. duration:
10 min
Sex:
male/female
Dose descriptor:
LC50
Effect level:
19 960 mg/m³ air
95% CL:
19 050 - 20 920
Exp. duration:
20 min
Sex:
male/female
Dose descriptor:
LC50
Effect level:
14 170 mg/m³ air
95% CL:
13 500 - 14 870
Exp. duration:
40 min
Sex:
male/female
Dose descriptor:
LC50
Effect level:
11 590 mg/m³ air
95% CL:
10 860 - 12 380
Exp. duration:
60 min
Sex:
male
Dose descriptor:
LC50
Effect level:
9 850 mg/m³ air
95% CL:
8 490 - 11 430
Exp. duration:
60 min
Sex:
female
Dose descriptor:
LC50
Effect level:
13 770 mg/m³ air
95% CL:
12 350 - 15 340
Exp. duration:
60 min
Mortality:
Mortality data are presented in Table 1.
Clinical signs:
other: Eye-irritation; especially in animals exposed for 60 minutes, wet noses, nasal discharge, mouth breathing, restlessness and laboured respiration were seen during exposure.
Body weight:
Not reported
Gross pathology:
Macroscopic examination revealed haemorrhagic lungs in animals that died during the study and also those that were sacrificed at study termination.
Other findings:
No other findings

Any other information on results incl. tables

Table 1. Mortality Data

Ammonia Concentration (mg/m³ air)

Exposure time (min)

Mortality rate (%)

Males

Females

Both Sexes Combined

20950

10

0

0

0

23380

20

0

10

26410

100

20

60

27220

100

0

50

37820

100

80

90

18290

20

60

0

30

19030

20

0

10

19450

100

40

70

21420

60

60

60

23200

100

80

90

12620

40

40

0

20

13410

80

20

50

15870

80

20

50

16290

100

60

80

16840

100

40

70

9870

60

40

20

30

10230

80

0

40

11300

100

0

50

12500

100

20

60

13240

100

40

70

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
As the exposure period increased, the LC50 decreased in value from 28130 mg
Executive summary:

The acute inhalation toxicity of ammonia was assessed by exposing groups of male and female Wistar rats were to atmospheric ammonia for 10, 20, 40 or 60 minutes. Following exposure surviving rats were housed 5 per cage and observed for 14 days.

Clinical symptoms included eye irritation, wet noses and nasal discharge. Autopsy revealed haemorrhagic lungs. The 60 minute LC50 in male rats was 9850 mg/m³ air. The 60 minute LC50 in female rats was 13770 mg/m³ air.