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EC number: 205-359-9 | CAS number: 139-40-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- from 21 October 1986 to 14 November 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- the statistical analysis has not been carried out
- Qualifier:
- according to guideline
- Guideline:
- other: AMES, B.N., F.D. LEE and W.E. DURSTON (1973), An Improved Bacterial Test System for the Detection and Classification of Mutagens and Carcinogens. Proc. Natl. Acad. Sci. USA 70, 782786.
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: AMES, B.N.,W.E. DURSTON, E. YAMASAKI and F.D. LEE (1973), Carcinogens are Mutagens: A Simple Test System Combining Liver Homogenates for Activation and Bacteria for Detection. Proc. Natl. Acad. Sci. USA 70, 22812285.
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: AMES, B..N., J. McCANN, and E: YAMASAKI (1975), Methods for Detecting Carcinogens and Mutagens with the Salmonella/Mammalian Microsome Mutagenicity Test. Mutation Res. 31, 347364.
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Propazine
- EC Number:
- 205-359-9
- EC Name:
- Propazine
- Cas Number:
- 139-40-2
- Molecular formula:
- C9H16ClN5
- IUPAC Name:
- 6-chloro-N2,N4-bis(propan-2-yl)-1,3,5-triazine-2,4-diamine
- Details on test material:
- Test material: propazine
Batch No. op. 909005
Purity: 100%
Stability: ensured by the sponsor
Validity (expiration date): ensured by the sponsor
Constituent 1
Method
- Target gene:
- The test substance was tested for mutagenic effects on histidine-auxotrophic mutants of Salmonella typhimurium.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- other: histidine-auxotrophic
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver microsomes and co-factors
- Test concentrations with justification for top dose:
- 0.008 - 5000 µg/0.1 ml, range in the toxicity test
20 - 5000 µg/0.1 ml, range in the mutagenicity test. - Vehicle / solvent:
- Dimethylsulfoxide (DMSO)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMDO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: daunorubi-cin-HCl (DAUNOBLASTIN, Farmitalia, Montedison Farmaceutica GmbH, Freiburg, i., Br., Germany) 5 and 10 µg/0.1 ml phosphate buffer
- Remarks:
- for strain TA 98
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- for strain TA 100
Migrated to IUCLID6: (Fluka, Buchs, Switzerland), 0.125 and 0.25 µg/0.1 ml phosphate buffer
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- for TA 1535
Migrated to IUCLID6: (Fluka, Buchs, Switzerland), 2.5 and 5 µg/0.1 ml bidistilled water
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 9(5) -aminoacridine hydrochloride monohydrate (Fluka, buchs, Switzerland), 50 and 100 µg/0.1 ml dimethylsulfoxide
- Remarks:
- for TA 1537
- Details on test system and experimental conditions:
- A preliminary toxicity test was carried out with strain TA 100 without activation with the concentrations ranging from 0.08 to 5000 µg/0l ml. The protocol used was the same as in the mutagenicity test. Accordingly, the concentration of 5000 µg/0.l ml was used as the highest in the mutagenicity test and the tests were performed with the following concentrations of the trial substance without and with microsomal activation: 20, 78, 313, 1250 and 5000 µg/0.1 ml. The substance is dissolved in dimethylsulfoxide (Siegfried, Zofingen, Switzerland). The solution is prepared by treating with ultrasound (Bransonic 220 water bath, 120 W) for 30 minutes at room temperature and sterilizd by filtration through a 0.22 µm filter. Dimethylsulfoxide alone is used for the negative controls. Each Petri dish contains:
1) approx. 20 ml of minimum agar (Agar (Difco Laboratories, Detroit, Michigan, U.S.A.), plus salts (VogelBonner Medium E) and glucose (Fluka, Buchs, Switzerland))
2) 0.1 ml of a solution of the test substance or the vehicle and 0.1 ml of a bacterial culture (in nutrient broth, Difco Laboratories, Detroit, Michigan, U.S.A., 0.8% plus 0.5% NaCl, or nutrient broth No. 2, Oxoid Ltd., Basingstoke, Hants., England, 2.5%) in 2.0 ml of soft agar.
The soft agar is composed of: 100 ml of 0.6% agar solution with 0.6% NaCl. and 10 ml of a solution of 1histidine, 0.5 mM (Fluka, Buchs, Switzerland or Merck, Darmstadt, Germany) and +biotin, 0.5 mM (Sigma, St. Louis, MO., U.S.A.).
In the experiments in which the substance is metabolically activated, 0.5 ml of an activation mixture is added also.
1 ml activation mixture contains: 0.3 ml S9 fraction of liver from rats (Tif:RAIf(SPF)) induced with Aroclor 1254 (Analabs.,Inc., North Haven, Connecticut, U.S.A.) and 0.7 ml of a solution of co-factors.
In the experiments without and with the addition of microsomal activation mixture three Petri dishes are prepared per strain and per group (i.e. per concentration or per control group).
The plates are incubated for about 48 hours at 37 ± 1.5 °C in darkness. - Evaluation criteria:
- Criteria for a positive response:
The test substance is considered to be positive in this test system if one or both of the following conditions are met:
a reproducible doubling of the mean number of revertants per plate above that of the negative control at any concentration level for one or more of the following strains: TA 98, TA 1535 and TA 1537,
a reproducible increase of the mean number of revertants per plate for any concentration above that of the negative control by a factor of 1.5 for strain TA 100.
Generally a concentration-related effect should be demonstrable.
Assay acceptance criteria:
A test is considered acceptable if the mean colony counts of the control values of all strains are within the acceptable range derived from experience for mean colony counts ( mean of three values) of spontaneous revertants and if the results of the positive controls meet the criteria for a positive response.
In either case the final decision has to be based on scientific judgement. - Statistics:
- see above
Results and discussion
Test results
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the experiments performed without and with microsomal activation, comparison of the number of back-mutant colonies in the controls an the cultures treated with the various concentrations of the test substance, revealed no marked deviations.
No evidence of the induction of point mutations by the test substance or by the metabolites of the substance formed as a result of microsomal activation was detectable in the strains of S. typhimurium used in these experiments.
At the concentrations of 1250 and 5000 µg/0.l ml the substance precipitated in soft agar. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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