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EC number: 223-829-1 | CAS number: 4090-51-1
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:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to guideline with deficiencies in data reporting
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide
- EC Number:
- 223-829-1
- EC Name:
- 2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide
- Cas Number:
- 4090-51-1
- Molecular formula:
- C10H20O5P2S2
- IUPAC Name:
- 2,2'-oxybis(5,5-dimethyl-1,3,2-dioxaphosphinane) 2,2'-disulfide
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: CFLP
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Anglia Laboratory Animals, Huntingdon, UK
- Weight at study initiation: 19-23 g
- Assigned to test groups randomly: yes
- Housing: in groups of 5
- Diet (ad libitum): Grain Harvester Anglia Laboratory Animal diet
- Water (ad libitum): tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 50 +/- 5
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Concentration of test material in vehicle: 125-500 mg/mL
- Amount of vehicle (if gavage or dermal): 0.1 mL - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
with Silverstone high speed mixer - Duration of treatment / exposure:
- 24 h between first and second application
- Frequency of treatment:
- twice
- Post exposure period:
- 6 h after second application
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2500, 5000, 10000 mg/kg
Basis:
nominal conc.
divided in two doses, separated by a 24 h interval
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- mitomycin C
- Doses / concentrations: 2 x 7 mg/kg
Examinations
- Tissues and cell types examined:
- 2000 polychromatic erythrocytes from bone marrow smears per animal
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
based on a preliminary toxicity test
DETAILS OF SLIDE PREPARATION:
fixed in methanol, defatted in xylene and stained by Giemsa
METHOD OF ANALYSIS:
optical examination - Evaluation criteria:
- not stated in detail
- Statistics:
- not stated
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 0-10000 mg/kg (divided in 2 doses, separated by an interval of 24 h)
- Clinical signs of toxicity in test animals: no toxic effects, no mortality
Any other information on results incl. tables
Historical control values from the laboratory were reported for comparison
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of this micronucleus study the test substance did not induce micronuclei in mice in the bone marrow. - Executive summary:
CFLP mice (5 per sex and dose) were gavaged with 0, 2500, 5000 and 10000 mg/kg (divided in 2 applications) of the test item. 6 h after the second dose, polychromatic erythrocytes from bone marrow were analysed for the induction of micronuclei. Under the conditions of this study the test substance did not induce micronuclei. In addition, no other toxic effects were oberved.
An appropriate positive control showed a mutagenic response, thus confirming the validity of this study.
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