Registration Dossier
Registration Dossier
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EC number: 701-184-1 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The restrictions were that only a short exposure time was used. It was not compliant with GLP.
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 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- only short exposure time used
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Potassium salts of [hexane-1,6-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid (4-7 K:1)
- EC Number:
- 701-184-1
- Molecular formula:
- HMDTMP-4K C10H24K4N2O12P4 HMDTMP-5K C10H23K5N2O12P4 HMDTMP-6K C10H22K6N2O12P4 HMDTMP-7K C10H21K7N2O12P4
- IUPAC Name:
- Potassium salts of [hexane-1,6-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid (4-7 K:1)
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Thymidine kinase
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 5-30 µl/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: none given in study report
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation 0.5 µl/ml
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: dimethylnitrosamine 0.3 µl/ml
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent): 10 days
SELECTION AGENT (mutation assays): selection medium containing 5% v/v BrdU
NUMBER OF REPLICATIONS: triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth
ACTIVATION: NADP and isocitric acid were used as co-factors. Final concentration of S9 is not clearly indicated in the report. - Evaluation criteria:
- A substance is considered mutagenic if there is a dose-related increase over 3 concentrations with the minimum increase at least 2.5 times the solvent and/or negative control values.
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 20 µl/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results of mutagenicity assay (mean of three plates)
Concentration µl/ml |
Relative cloning efficiency |
Relative total growth |
Mutant frequency |
|||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
Negative control |
100 |
100 |
100 |
100 |
9.0 |
7.0 |
Solvent control |
92.2 |
102.4 |
67.0 |
102.8 |
15.5 |
14.3 |
5 |
68.4 |
71.7 |
74.7 |
81.2 |
8.8 |
8.6 |
10 |
79.9 |
100.8 |
62.2 |
80.8 |
6.4 |
14.1 |
15 |
73.6 |
82.5 |
64.4 |
83.5 |
15.6 |
7.3 |
20 |
60.0 |
40.7 |
57.1 |
36.7 |
13.6 |
4.3 |
30 |
5.4 |
2.0 |
3.9 |
2.2 |
28.3 |
9.6 |
Positive control |
35.4 |
7.3 |
18.0 |
0.3 |
180.4 |
700 |
Applicant's summary and conclusion
- Conclusions:
- HMDTMP (4-7K) has been tested according to a protocol that is similar to OECD 476. No increase in the mutant frequency was observed at any concentration up to cytotoxic concentrations, with and without metabolic activation. Appropriate positive, solvent and negative controls were included and gave the expected results. It is concluded that the substance is negative for mutagenicity to L5178Y mouse lymphoma cells under the conditions of the test.
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