Registration Dossier
Registration Dossier
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EC number: 296-664-6 | CAS number: 92908-35-5
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:
- key study
- Study period:
- 21.09.-14.10.1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (GLP)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Details on test material:
- - CAS number (as cited in study report): 1854-26-8
- Physical state: liquid
- Analytical purity: 73%
- Lot/batch No.: 682
- Storage condition of test material: at 5°C >= 21 d
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Mollegaard, Germany
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 20-27g
- Assigned to test groups randomly: no
- Housing: Macrolon Typ 3
- Diet (e.g. ad libitum): Altromin Nr . N 1326, ad libitum
- Water (e.g. ad libitum): drinking water
- Acclimation period: 4 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 55+-10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
3 days before application.
0.1 ml solution was applicated to 10 g body weight. - Frequency of treatment:
- single application
- Post exposure period:
- 24 h (additionally 48 h in the 2000 mg/kg treatment)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000, and 2000 mg/kg as 73 % solution in water
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s):
- Route of administration: oral
- Doses / concentrations: 20/80 mg/kg b.w. (24 hrs post exposure period)
Examinations
- Tissues and cell types examined:
- bone marrow of the femora; 2000 polychromatic erythrocytes per animal were studied for the presence of micronucleus.
- Evaluation criteria:
- Micronucleus
- are round, oval or crescent-shaped
- have a precise contour
Application of high doses of clastogenic substances can cause the appearence of several almond- or ring-shaped micronuclei.
- are uniformly coloured
- have a diameter of approximately 1/20 to 1/5 of an erythrocyt
- Es ist meistens nur ein Mikrokem vorhanden .
- Nach Behandlung mit hohen Dosen von Substanzen, die Chromosomenbrüche erzeugen, können
bei einigen Erythrozyten auch mehrere Mikrokeme auftreten, die auch mandelförmig oder ringförmig
sein können
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
| Substance | Dose (mg/kg) | Sex | post exposure period (h) | PCE with micronuclei | total number of PCE | Ratio PCE/NCE |
| vehicle | solvent | male | 24 | 0.30 | 6.0 | 0.97 |
| female | 24 | 0.34 | 6.8 | 0.96 | ||
| test substance | 500 | male | 24 | 0.31 | 6.2 | 0.99 |
| female | 24 | 0.27 | 5.4 | 0.98 | ||
| test substance | 1000 | male | 24 | 0.36 | 7.2 | 1.02* |
| female | 24 | 0.32 | 6.4 | 1.00 | ||
| test substance | 2000 | male | 24 | 0.24 | 4.8 | 0.95 |
| female | 24 | 0.26 | 5.2 | 0.97 | ||
| test substance | 2000 | male | 48 | 0.37 | 7.4 | 0.99 |
| female | 48 | 0.33 | 6.6 | 0.99 | ||
| positive ctrl | 80 | male | 24 | 2.01 | 40.2 | 0.69 |
| female | 24 | 1.90 | 38.2 | 0.69 | ||
| positive ctrl | 20 | male | 24 | 0.86 | 17.4 | 0.76 |
| female | 24 | 0.82 | 16.4 | 0.86 | ||
| PCE = polychromatic erythrocyts (2000 were scored for micronuclei) | ||||||
| NCE = normochromatic erythrocyts | ||||||
| The NCE/PCE ratio (as an indicator of cytotoxicity) is based on the scoring of 1000 erythrocyts | ||||||
| * = significantly different from the control, but within historical control data (0.6 to 1.2) | ||||||
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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