Registration Dossier
Registration Dossier
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EC number: 200-589-6 | CAS number: 64-67-5
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:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to the guideline but the toxicity is not evaluated. The objective was to define the best sampling time for the guideline.
Data source
Reference
- Reference Type:
- publication
- Title:
- An optimal, generalized sampling time of 30 ± 6 h after double dosing in the mouse peripheral blood micronucleus test
- Author:
- Higashikuni N, Sutou S
- Year:
- 1 995
- Bibliographic source:
- Mutagenesis 10(4): 313-319
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Deviations:
- yes
- Remarks:
- toxicity is not assessed
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- Additional sampling time were included in the study
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Diethyl sulphate
- EC Number:
- 200-589-6
- EC Name:
- Diethyl sulphate
- Cas Number:
- 64-67-5
- Molecular formula:
- C4H10O4S
- IUPAC Name:
- diethyl sulfate
- Details on test material:
- supplier: Nacalai Tesque Inc (Japan)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: MS/Ae
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- Injected twice, at 24 h interval.
- Frequency of treatment:
- see above
- Post exposure period:
- 24 to 60 h after the 2nd treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
80 and 160 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- other: Same animals, sampling time before treatment
Examinations
- Tissues and cell types examined:
- reticulocytes
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- positive
- Toxicity:
- not examined
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
Any other information on results incl. tables
Dose |
Sampling time (h) |
Number of animals |
Mean MN/1000 RET |
SD |
80 |
0 |
5 |
3.20 |
1.64 |
24 |
8.60 |
1.67 |
||
30 |
9.00 |
5.10 |
||
36 |
7.40 |
2.07 |
||
42 |
5.60 |
2.07 |
||
48 |
2.80 |
1.92 |
||
54 |
2.20 |
2.49 |
||
60 |
2.20 |
1.92 |
||
160 |
0 |
5 |
3.00 |
1.00 |
24 |
4 |
8.75 |
2.87 |
|
30 |
15.50 |
3.32 |
||
36 |
13.25 |
2.50 |
||
42 |
9.75 |
2.06 |
||
48 |
8.75 |
2.36 |
||
54 |
6.75 |
1.26 |
||
60 |
2.75 |
1.50 |
MN = micronucleated cell
RET = reticulocytes
SD = standard deviation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
DES induced micronucleus in the reticulocytes of mouse. Peak responses are observed around 30 h after the second treatment. - Executive summary:
A micronucleus test was performed in mice treated by ip with 80 or 160 mg/kg (2 injections). Sampling time was between 24 and 60 h after the second injection.
In the conditions of this test, DES induced micronucleus, the peak response was between 34 and 36 h.
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