Registration Dossier
Registration Dossier
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EC number: 219-956-7 | CAS number: 2582-30-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- Aminoguanidinium hydrogen carbonate
- EC Number:
- 219-956-7
- EC Name:
- Aminoguanidinium hydrogen carbonate
- Cas Number:
- 2582-30-1
- Molecular formula:
- CH6N4.CH2O3
- IUPAC Name:
- carbamimidoyldiazanium hydrogen carbonate
- Test material form:
- other: solid
- Details on test material:
- content 99.6 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 - 14 weeks
- Weight at study initiation: 140-160 g
- Housing: singly
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 40-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light: 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 0.5 %aquous Cremophor
- Details on exposure:
- Animals received single oral doses of aminoguanidinium hydrogen carbonate 4 and 16 hours after administration the liver cells were gathered by perfusion in situ and were prepared according to the protocol of Butterworth et al (1987), Mutation Res 189, 113-121 under sterile conditions.
- Duration of treatment / exposure:
- 4 and 16 hours
- Frequency of treatment:
- once
- Post exposure period:
- no
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1000, 2500 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- N,N'-Dimethylhydrazin, 2-Acetylamino-fluorene
Examinations
- Tissues and cell types examined:
- liver cells
- Details of tissue and slide preparation:
- according to the respective guideline
- Evaluation criteria:
- The increase in net nuclear grain (NNG) counts compared to vehicle control animals is used as criterion for induced DNA damage.
If a chemical yields +2 NNG or more (dose group average) and with 11 % or more of the cells responding, the response is considered positive. - Statistics:
- no data
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- 1/5 died (2500 mg/kg bw); roughened fur, wide-legged gait, discolored feces
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No cytotoxicity as observable in isolated hepatocytes of exposed animals.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
The Unscheduled DNA Synthesis (UDS) Assay was employed to investigate aminoguanidinium hydrogen carbonate in vivo in male rats for a possible genotoxic effect on the DNA of liver cells. The known UDS-inducers 2-Acetylaminofluorene and N,N'-Dimethylhydrazine served as positive controls. Animals received aminoguanidinium hydrogen carbonate in a single oral dose of 1000 mg/kg and 2500 mg/kg, respectively.
The males treated with aminoguanidinium hydrogen carbonate showed symptoms of toxicity after administration, starting at 1000 mg/kg. One of 5 animals died before the end of the test due to the acute oral toxicity of aminoguanidinium hydrogen carbonate at a dose of 2500 mg/kg. The liver cells of groups treated with aminoguanidinium hydrogen carbonate and of the negative controls were prepared 4 and 16 hours after administration. No cytotoxicity was observable in isolated hepatocytes of exposed animals. No indications of UDS-induction by aminoguanidinium hydrogen carbonate were found after a single oral treatment with 1000 mg/kg and 2500 mg/kg. The positive controls were functional.
Based on these results, aminoguanidinium hydrogen carbonate was evaluated as inactive in the In Vivo UDS Assay with rat liver cells.
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