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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 40 CFR798.5395
GLP compliance:
not specified
Type of assay:
mammalian bone marrow chromosome aberration test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
453-090-2
EC Name:
-
Cas Number:
140456-78-6
Molecular formula:
NH4 N(NO2)2
IUPAC Name:
Ammonium dinitroazanide
Test material form:
solid: particulate/powder

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8-10 wks old

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
distilled water
Duration of treatment / exposure:
3 consecutive days (62.5-750 mg/kg/dose)
Post exposure period:
24 hrs
Doses / concentrationsopen allclose all
Dose / conc.:
2 000 mg/kg bw (total dose)
Dose / conc.:
1 000 mg/kg bw (total dose)
Dose / conc.:
500 mg/kg bw (total dose)
No. of animals per sex per dose:
3 per group
Control animals:
not specified
Positive control(s):
cyclophosphamide (20 mg/kg/ dose by i.p..injection) was used as the positive control.

Examinations

Evaluation criteria:
The PCEs/ NCEs ratio was determined by counting 1000 erythrocytes, and used as the indicator of toxicity.
Micronuclei are defined as round bodies in cytoplasm with a diameter of 1/20 to 1/5 of an erythrocyte.
They stain intensively, similar to the staining of the main nuclei in the nucleated cells.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
not specified
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The above results indicate that under the experimental conditions, ADN significantly increases the micronucleated cell frequency in the Swiss CD-1 mice polychromatic erythrocyte system in a dose -dependent manner, suggesting its cromosome-damage effect in the in vivo assay.