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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:
EPA OPP 84-2
Deviations:
no
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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