Ammonium acetate

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

based on test type (migrated information)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: A scientific study. No GLP.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1993

Materials and methods

Principles of method if other than guideline:

From 2 to 4.5 months of age, 80 crossbred gilts were reared in a conventional grower unit where they were naturally exposed to mycoplasmal and bacterial pathogens that cause pneumonia and atrophic rhinitis. At 4.5 months of age, gilts were moved to environmentally regulated rooms (4.9 x 7.3 m) and assigned at random to 1 of 2 treatment groups: low aerial concentration of ammonia (4 to 12 ppm; mean, 7 ppm) or moderate aerial concentration of ammonia (26 to 45 ppm, mean, 35 ppm). Low concentration of ammonia was obtained by flushing of manure pits weekly, whereas moderate concentration of ammonia was maintained by adding anhydrous ammonia to manure pits that were not flushed. Gilts were weighed biweekly. Mean daily gain (MDG) was less (P < 0.01) for gilts exposed to moderate concentration of ammonia than for gilts exposed to low concentration of ammonia after 2 weeks in their respective environments. By 4 and 6 weeks, however, MDG was similar between the 2 treatment groups. After 6 weeks in these environments, 20 gilts from each treatment group were slaughtered, and prevalence and severity of lung lesions and snout grades were determined.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonia, anhydrous

EC Number:

231-635-3

EC Name:

Ammonia, anhydrous

Cas Number:

7664-41-7

IUPAC Name:

ammonia

Details on test material:

- Name of test material (as cited in study report): Ammonia anhydrous

Test animals

Species:

pig

Strain:

not specified

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4.5 wks

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure (if applicable):

whole body

Vehicle:

not specified

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

female pigs were continuously exposured to 7 and 35 ppm ammonia for 6 weeks before breeding until 30 day of gestation.

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
7 during 6 weeks
Basis:
other: by inhalation

Doses / concentrations 2

Remarks:

Doses / Concentrations:
35 dirung 6 weeks
Basis:
other: by inhalation

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

effects observed, treatment-related

Reproductive function / performance (P0)

Reproductive performance:

effects observed, treatment-related

Effect levels (P0)

Dose descriptor:

NOAEC

Effect level:

35 ppm (nominal)

Based on:

test mat.

Sex:

female

Basis for effect level:

other: (reproductive effects)

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

No statistically significant differences were noted in ovarian or uterine weights of pigs exposed to about 7 and 35 ppm ammonia for 6 weeks. Female pigs were continuously exposured to 7 and 35 ppm ammonia for 6 weeks before breeding until 30 day of gestation had no statistically significant differences in age at puberty, number of live fetuses, or -to-corpus luteum ration compared to pigs exposed only to 7 ppm. No unexposed controls were included in the study.

Applicant's summary and conclusion

Conclusions:

No statistically significant differences were noted in ovarian or uterine weights of pigs exposed to about 7 and 35 ppm ammonia for 6 weeks. Female pigs were continuously exposured to 7 and 35 ppm ammonia for 6 weeks before breeding until 30 day of gestation had no statistically significant differences in age at puberty, number of live fetuses, or -to-corpus luteum ration compared to pigs exposed only to 7 ppm. No unexposed controls were included in the study.

Executive summary:

No statistically significant differences were noted in ovarian or uterine weights of pigs exposed to about 7 and 35 ppm ammonia for 6 weeks. Female pigs were continuously exposured to 7 and 35 ppm ammonia for 6 weeks before breeding until 30 day of gestation had no statistically significant differences in age at puberty, number of live fetuses, or -to-corpus luteum ration compared to pigs exposed only to 7 ppm. No unexposed controls were included in the study.