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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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