Registration Dossier
Registration Dossier
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EC number: 227-824-5 | CAS number: 5994-61-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 15 to August 25, 1977
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline not mentioned, procedure followed is equivalent to OECD Guideline 471
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(carboxymethyl)-N-(phosphonomethyl)glycine
- EC Number:
- 227-824-5
- EC Name:
- N-(carboxymethyl)-N-(phosphonomethyl)glycine
- Cas Number:
- 5994-61-6
- Molecular formula:
- C5H10NO7P
- IUPAC Name:
- 2-[(carboxymethyl)(phosphonomethyl)amino]acetic acid
- Details on test material:
- - Name of test material (as cited in study report): CP 41820 (code name for glyphosate intermediate, N-(carboxymethyl)-N-(phosphonomethyl)glycine)
- Physical state: White powder
Constituent 1
Method
- Target gene:
- Not reported
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- None
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- None
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- Saccharomyces cerevisiae
- Details on mammalian cell type (if applicable):
- None
- Additional strain / cell type characteristics:
- other: strain D4
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (Aroclor 1254 treated Sprague-Dawley rat liver microsomal fraction) mixed with activation medium
- Test concentrations with justification for top dose:
- 0.1, 1.0, 10.0, 100.0 and 500.0 µg/plate, both with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO, used at 50 µL/plate for solvent control groups
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water or saline
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- at 10 µg/plate, with TA 1535 and 100 and D4
Migrated to IUCLID6: without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- at 100 µg/plate, with TA 1538 and 98
Migrated to IUCLID6: without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water or saline
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Quinacrine mustard, without S9
- Remarks:
- at 10 µg/plate, with TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine, with S9
- Remarks:
- at 100 µg/plate, with TA 1535 and 100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Remarks:
- at 100 µg/plate, with TA 1538 and 98
Migrated to IUCLID6: with S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 8-aminoquinoline, with S9
- Remarks:
- at 100 µg/plate, with TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-dimethylnitrosamine
- Remarks:
- at 100 µM/plate, with D4
Migrated to IUCLID6: with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
For tests with metabolic activation: Tubes containing 2 mL molten agar supplemented with biotin and trace of histidine were mixed with the test concentrations and 0.5 mL of S9 mix. This mixture was then poured over agar plates and allowed to solidify.
For tests without metabolic activation: Tubes containing 2 mL molten agar supplemented with biotin and trace of histidine were mixed with the test concentrations. This mixture was then poured over agar plates and allowed to solidify.
The plates were incubated for 48 hours at 37°C and then evaluated for mutagenicity.
DURATION
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
NUMBER OF REPLICATIONS: One
NUMBER OF CELLS EVALUATED: Not reported
DETERMINATION OF CYTOTOXICITY
- Method: Not reported - Evaluation criteria:
- Strains TA 1535, 1537 and 1538:
Provided the solvent control value is within the normal range, a chemical that produces a positive dose response over three concentrations with the lowest increase equal to twice the solvent control value, is considered to produce a positive mutagenic response.
Strains TA 98 and 100 and D4:
Provided the solvent control value is within the normal range, a chemical that produces a positive response over three concentrations with the highest increase equal to twice the solvent control value for TA 100 and 2-3 times the solvent control value for TA 98 and D4, is considered to produce a positive mutagenic response.
Reproducibility:
The results produced by the chemical in one test (replicate) should reproduce the results in other tests (replicates) as well. - Statistics:
- Not reported
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- Saccharomyces cerevisiae
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- None
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results, the test material, CP 41820 BIO-77-212, was found to be non-mutagenic under the conditions of this test. - Executive summary:
A study was conducted to determine the mutagenic potential of CP 41820 BIO-77-212 in a bacterial reverse mutation test in a procedure equivalent to OECD Guideline 471 and according to the method of Ames et al. (1975).
A total of five strains of Salmonella typhimurium (TA 98, 100, 1535, 1537 and 1538) and the strain D4 of Saccharomyces cerevisiae
were exposed to five different concentrations of the test material (0.1, 1.0, 10.0, 100.0 and 500.0 µg/plate) in a plate incorporation assay, with or without metabolic activation. The plates were then incubated for 48 hours at 37°C and were evaluated for mutagenicity.
None of the test plates with and without metabolic activation produced any positive response.
Based on the results, the test material, CP 41820 BIO-77-212, was found to be non-mutagenic under the conditions of this test.
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