Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Deviations:
yes
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Diisopropylamine
- Lot: 3885009-C
- Purity: 99%

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Details on exposure:
5 animals were sacrificed at 24 and at 48 hours after treatement.
Duration of treatment / exposure:
single ip injection
Frequency of treatment:
single ip injection
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
up to 3500mg/kg
Basis:
nominal conc.
Dose range finding test : dose up to 3500mg/kg
Remarks:
Doses / Concentrations:
70 mg/kg
Basis:
nominal conc.
main test (dose chosen from the range finding test)
No. of animals per sex per dose:
10 mice per sex per group
Control animals:
yes, concurrent vehicle
Positive control(s):
yes, but no further data
Positive control animals were sacrifice 24 hours after treatement.

Examinations

Details of tissue and slide preparation:
Bone marrow samples were sampled.
Slides were prepared to determine [polychromatic erythrocytes(PCE)/ total erythrocyte] ratios and the number of micronucleated PCEs per 1000 erythrocytes.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
at 100 mg/kg and above
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No deaths or significant body weight decreases were observed in the main study.
A statistically significant (p<0.05) decrease in the PCE/total erythrocyte ratio was observed in the treated male mice at the 24 hours sacrifice.
No statistically significant decrease in the PCE/total erythrocyte ratio was observed for any other animals.
No statistically significant increase in the number of micronucleated PCEs was observed in treated animals ,when compared to controls.

Any other information on results incl. tables

Dose range finding test : Toxicity signs (and deaths) were observed at 100 mg/kg and above: deaths in male mice at 100 mg/kg and in female mice at 200 mg/kg).

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative