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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
only 4 animals per sex per dose; only one sample of bone marrow; only 2 doses
Principles of method if other than guideline:
Method: Schmid W, Mutation Res, 31, (1975), 9-15.
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified
Details on test material:
CAS No. 7414-83-7
Disodium ethane-1-hydroxy-1,1-diphosphonate, purity, source not stated.

Test animals

Species:
mouse
Strain:
CF-1
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 weeks

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: no data
Duration of treatment / exposure:
Two intraperitoneal doses at 0 and 24 hours
Doses / concentrationsopen allclose all
Dose / conc.:
18.75 mg/kg bw/day (nominal)
Dose / conc.:
150 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
four
Control animals:
yes, concurrent no treatment
Positive control(s):
- Endoxan
- Doses / concentrations: 120 mg/kg bw

Examinations

Tissues and cell types examined:
Femoral bone marrow

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Table 1: Mean Results of in vivo micronucleus test with mouse bone marrow

 -

Negative Control

Negative Control

Positive Control (Endoxan)

Positive Control (Endoxan)

Low dose

18.75 mg/kg

Low dose

18.75 mg/kg

High dose

150 mg/kg

High dose

150 mg/kg

male

female

male

female

male

female

male

female

Sampling time (h)

6

6

6

6

6

6

6

6

Number of cells analysed

1000

1000

1000

1000

1000

1000

1000

1000

Micronucleated cells per animal %

3

3.3

35

34

3

2.8

3.3

1.5

Ratio PCE/NCE

782

815

250

386

785

852

875

947

Applicant's summary and conclusion

Conclusions:
HEDP, disodium salt has been tested in a mouse micronucleus assay. No increase in the number of PCEs was detected after ip administration. It is concluded that the test substance is negative for induction of micronuclei under the conditions of the test.