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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 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:
1992

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

Constituent 1
Chemical structure
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

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