2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide

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:

1978

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

Test material information

Constituent 1

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

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.