Registration Dossier
Registration Dossier
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EC number: 229-222-8 | CAS number: 6440-58-0
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione
- EC Number:
- 229-222-8
- EC Name:
- 1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione
- Cas Number:
- 6440-58-0
- Molecular formula:
- C7H12N2O4
- IUPAC Name:
- 1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione
- Details on test material:
- Glydant® is a 55% solution of DMDMH in water
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Sterile deionized water
- Duration of treatment / exposure:
- Not applicable
- Frequency of treatment:
- Once
- Post exposure period:
- 24, 48, 72 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
4000 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
2000 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 males and 5 females per dose level and sampling time (supplementary animals were dosed at 4000 mg/kg so that samples from a total of 5 animals/sex could be examined at 4000 mg/kg)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide solubilised in sterile deionized water and administered at 80mg/kg.
Examinations
- Tissues and cell types examined:
- bone marrow
Number of animals: all animals
Number of cells: 1000
Time points: 24, 48, 72 h after treatment
Type of cells: erythrocytes in bone marrow
Parameters: polychromatic/normochromatic erythrocytes ratio and occurrence of micronuclei
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
~23.5 hours after dosing, 2 males from the 4000mg/kg supplementary group were found dead. One male from the 4000 mg/kg had squinted eyes and appeared languid. Prior to 72 hour harvest, 1 female from the supplementary group had developed a distended abdomen.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test material Glydant® did not induce a significant increase in micronuclei in bone marrow polychromatic erythrocytes
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