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EC number: 620-365-5 | CAS number: 9016-72-2
- 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 mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987/06/30 to 1987/10/22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study conforms to the OECD Principles of Good Laboratory Practice (Bundesanzeiger Nr. 42a/7of, 2nd of March 1983). The study is not fully compliant with the current guideline with respect to the number of cells exposed and background mutation rate, and is therefore of limited sensitivity.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
Test material
- Reference substance name:
- polymeric zinc 1,2-propylenebis(dithiocarbamate)
- EC Number:
- 620-365-5
- Cas Number:
- 9016-72-2
- IUPAC Name:
- polymeric zinc 1,2-propylenebis(dithiocarbamate)
- Test material form:
- solid
- Remarks:
- Powder
Constituent 1
Method
- Target gene:
- HGPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Sprague-Dawley male rats, served as source of the S-9 fraction. A rat liver S-9 fraction buffered with 0.15M KC1. The positive control substances DMBA or 3-MCA were tested with each new batch of S-9 fraction for their ability to induce forward mutations in the CHO/HGPRT assay. Prior to use in the HGPRT test, the S-9 fraction was tested for contamination and for cytotoxicity.
- Test concentrations with justification for top dose:
- 0.16 - 40 µg/mL (-S9)
0.11 - 60 µg/mL (+S9)
After determination of the cytotoxicity of LH 30/Z, the concentration range of LH 30/Z for the mutagenicity study was chosen ranging from approximately 0% to 90% reduction in colony forming ability.
Due to the low cytotoxicity of LH 30/Z in the mutation assays, the test article concentration was increased during the study up to 40 µg/mL without metabolic activation and up to 60.0 µg/mL with metabolic activation. - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- ethylmethanesulphonate
- Evaluation criteria:
- An assay normally is considered acceptable for evaluation of the results only if the following
criteria are satisfied. However, the conclusion of the study will be based upon Study Director's evaluation and interpretation of the data. The activation and nonactivation assays were repeated independently in a second assay. The average cloning efficiency of the negative controls should be; at least 50%. Assays below 50% cloning efficiency will be unacceptable. The background mutant frequency (average of the negative control) should not exceed 25x10 cells. Assays with higher spontaneous mutant frequencies, however, are riot necessarily invalid if all other criteria are fulfilled.
An experimental mutant frequency is considered acceptable only if the absolute cloning efficiency is 10% or greater. The mutant frequencies for at least five treated cultures are normally determined in each assay. Mutant frequencies are normally derived from sets of 8-10 dishes for each dose level. To allow for contamination losses , an acceptable mutant frequency can be calculated from a minimum of 5 dishes. The positive control must induce a mutant frequency of at least three times that of the negative control. An assay will be considered positive if a dose-dependent and reproducible increase in mutant frequency is observed. It is desirable to obtain this dose-relation for at least 3 doses. - Statistics:
- All data are presented in tabular form, descriptive statistical methods were used to calculate means and standard deviation.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Increases in mutation frequencies were observed. However, these increases were not dose-related
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Due to the low cytotoxicity of LH 30/Z in the mutation assays, the test article concentration was increased during the study up to 40 µg/mL without metabolic activation and up to 60.0 µg/mL with metabolic activation.
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- Remarks:
- A stability test in the solvent was not done due to the non-homologous test compound.
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test material, propineb was assayed for mutagenic activity at the HGPRT locus in CHO cells from 0.16 µg/ml to 40 µg/ml without activation and from 0.11 µg/ml to 60.0 µg/ml with activation.
Under both treatment conditions, cytotoxicities were induced. The absolute cloning efficiencies for the vehicle controls varied from 80.0% to 108.8% without activation and from 73.2% to 108.8% with activation demonstrating good cloning conditions for the assays.
The vehicle control mutant frequencies were all in the normal range of background frequencies for the assay. In contrast, the positive controls EMS, DMBA and 3-MCA induced a distinct mutagenic effect in mutant frequency, which was significantly increased over the
negative controls.
From the lack of dose-related and reproducible increases in mutant frequency the test material is considered nonmutagenic in the CHO-HGPRT Forward Mutation Assay, both with and without metabolic activation, according to our evaluation criteria. - Executive summary:
Propineb was evaluated for mutagenic effects at the HGPRT locus (forward mutation assay) in CHO cell cultures after in vitro treatment at concentrations up to 40.0 µg/ml (without S-9 mix) and 60.0 µg/ml (with S-9 mix). Under both treatment conditions, LH 30/Z induced cytotoxic effects as seen by decreases in relative population growth and cloning efficiency. These results revealed a significant cytotoxicity of LH 30/Z, both with and without S-9 mix.
There were neither dose-related nor reproducible increases in mutant frequency which were significantly elevated over the negative controls. In contrast, the positive controls ethylmethanesulfonate (without S-9 mix), 3-inethylchola-nthrene and dimethylbenzanthracene (with S-9 mix) revealed a clear mutagenic effect in the assay. From these results, the test substance LH 30/Z can be considered, as nonmutagenic in the CHO-HGPRT Forward Mutation Assay, both with and without metabolic activation.
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