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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Not a guideline study. The information given is limited to the above mentioned. The aberration frequency at 5.2 mg/kg bw is without biological meaning and may be a mistake in the table. It is not clear whether a metaphase-arresting agent was added before sacrifice.

Data source

Reference
Reference Type:
publication
Title:
Evaluation of the mutagenic activity of ammonium nitrate and dimethylamine salt of 2,4-dichlorophenoxyacetic acid
Author:
Nechkina, MA
Year:
1992
Bibliographic source:
Gigiena i sanitariia (2); p. 66-7

Materials and methods

Principles of method if other than guideline:
Only one sex used, sampling earlier than 1.5 normal cell cycle; no positive controls.
GLP compliance:
not specified
Type of assay:
chromosome aberration assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium nitrate
EC Number:
229-347-8
EC Name:
Ammonium nitrate
Cas Number:
6484-52-2
Molecular formula:
H3N.HNO3
IUPAC Name:
ammonium nitrate
Test material form:
solid
Remarks:
granules or crystals
Details on test material:
No further details provided.

Test animals

Species:
mouse
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
- Sex: male
- Age: sexually-mature
- Number: 6/dose
- Controls: 9 animals vehicle only

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
15 days
Frequency of treatment:
daily
Post exposure period:
Sampling times and number of samples: 6 h after last administration
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw (total dose)
Dose / conc.:
5.2 mg/kg bw (total dose)
Dose / conc.:
20.9 mg/kg bw (total dose)
Dose / conc.:
104 mg/kg bw (total dose)
Dose / conc.:
417 mg/kg bw (total dose)
No. of animals per sex per dose:
6/dose
Control animals:
other: 9 animals vehicle only (vehicle = water)

Examinations

Tissues and cell types examined:
Chromosome preprations were prepared using the standard Ford method from bone marrow cells; 100 metaphases were examined per animal.

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Remarks:
No increase in aberrations was found in the treated groups relative to the negative control.
Additional information on results:
EFFECT ON MITOTIC INDEX OR PCE/NCE RATIO: not indicated

GENOTOXIC EFFECTS: No increase in aberrations was found in the treated groups relative to the negative control.

ABERRATION FREQUENCY:
- Number of metaphases with aberrations (gaps excluded): -0.5, 0.3, 0.7, 0.8 and 1.1 per 100 metaphases for 0, 5.2, 20.9, 104 and 417 mg/kg bw, respectively

Applicant's summary and conclusion