Registration Dossier
Registration Dossier
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EC number: 203-558-5 | CAS number: 108-18-9
Genetic toxicity: in vivo
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:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Diisopropylamine
- EC Number:
- 203-558-5
- EC Name:
- Diisopropylamine
- Cas Number:
- 108-18-9
- Molecular formula:
- C6H15N
- IUPAC Name:
- bis(propan-2-yl)amine
- Details on test material:
- Diisopropylamine
- Lot: 3885009-C
- Purity: 99%
Constituent 1
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
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