Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 453-090-2 | CAS number: -
Genetic toxicity: in vivo
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:
- 1 994
- 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
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
