Registration Dossier
Registration Dossier
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EC number: 231-838-7 | CAS number: 7758-29-4
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Pentasodium triphosphate
- EC Number:
- 231-838-7
- EC Name:
- Pentasodium triphosphate
- Cas Number:
- 7758-29-4
- Molecular formula:
- H5O10P3.5Na
- IUPAC Name:
- pentasodium bis(phosphonatooxy)phosphinate
- Details on test material:
- - Name of test material (as cited in study report): FDA 71-46 Sodium tripolyphosphate
- Lot/batch No.: #3063
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Flow laboratories
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 280-350g
- Assigned to test groups randomly: yes
- Housing:1-5/cage, sanitary cages and bedding
- Diet (e.g. ad libitum): commercial 4% fat diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period:4-11 days
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Acute study: 1 dose
Subacute study: 5 doses 24h apart - Frequency of treatment:
- Acute study: 1 dose
Subacute study:daily - Post exposure period:
- Acute study: 6, 24, 48 h
Subacute study: 6h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
see table 1
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control(s):
- triethylenemelamine
- Route of administration: Oral (gavage)
- Doses / concentrations: 0.3 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The highest dose was either a finite LD5 or 5000 mg/kg
The intermediate dose was either 1/10 of the finite LD5 or 2500 mg/kg
The low dose was either 1/100 of the finite LD5 or 30 mg/kg
DETAILS OF SLIDE PREPARATION:
Slides were stained using a 5% Giemsa solution, rinsed in acetone, 1:1 acetone:xylene and placed in fresh xylene for 30 min prior to mounting using Permount.
METHOD OF ANALYSIS:
The preparations were examined using brightfield optics microscopes with xenon light sources - Evaluation criteria:
- Only diploid cells were analyzed. Scored for chromatid gaps and breaks, chromosome gaps and breaks, reunions, cells with greater than then aberrations, polyploidy, pulverization and any other chromosomal aberrations.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
Any other information on results incl. tables
Test 1: Metaphase summary
Compound |
Dose (mg/kg) |
No of animals |
No of cells |
Mitotic index |
% cells with breaks |
% cells with reunion |
% cells other aber. |
% cells with aber. |
Negative control |
Saline |
3 |
150 |
10 |
4 |
0 |
0 |
4 |
Usage level |
2.5 |
5 |
250 |
6 |
2 |
0 |
0 |
2 |
Intermediate level |
25.0 |
5 |
250 |
7 |
4 |
0 |
0 |
4 |
LD5 |
250.0 |
5 |
25 |
8 |
3 |
1 |
0 |
4 |
Test 2: Subacute study. Metaphase summary
Compound |
Dosage (mg/kg) |
No of animals |
No of cells |
Mitotic index |
No of cells w/breaks |
no of cells w/reunion |
No of cells w/other aber |
No of cells w/aber |
High level |
1100 |
5 |
250 |
5.40 |
0 |
0 |
2 |
2 |
Negative control |
Saline |
3 |
150 |
7.67 |
0 |
0 |
1 |
1 |
Test 2: Acute study: metaphase summary
Compound |
Dosage (mg/kg) |
Time (hr) |
No of animals |
No of cells |
Mitotic index |
No of cells w/breaks |
no of cells w/reunion |
No of cells w/other aber |
No of cells w/aber |
High level |
2500 |
6 |
5 |
250 |
4.10 |
0 |
0 |
0 |
0 |
24 |
5 |
228 |
2.51 |
1 |
0 |
1 |
2 |
||
48 |
5 |
250 |
4.96 |
0 |
1 |
1 |
2 |
||
Negative control |
Saline |
6 |
3 |
150 |
5.07 |
1 |
0 |
1 |
1 |
24 |
3 |
150 |
4.20 |
0 |
0 |
1 |
1 |
||
48 |
3 |
150 |
5.13 |
0 |
0 |
1 |
1 |
||
Positive control |
0.3 |
48 |
5 |
250 |
2.92 |
17 |
25 |
>19 |
68 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Sodium Tripolyphosphate is non mutagenic as measured by the cytogenetic test.
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