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EC number: 411-930-5 | CAS number: 106917-31-1 SANDUVOR 3058; SANDUVOR 3058 LIQ.
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Hostavin 3058 was not mutagenic with or without metabolic activation in two bacterial reverse mutation assays with the strains S. typhimuriumTA 98, TA 100, TA 1535, TA 1537 and TA 1537. Additionally, a negative results in the presence and absence of metabolic activation was obtained with the read-across substance Hostavin 3055 using the strains
S. typhimuriumTA 98, TA 100, TA 1535, TA 1537 and TA102.
The structural analogue, Hostavin 3055, also yielded negative results in an in vitrogene mutation study in mammalian cells with and without metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- It can be concluded that the source substance did not induce gene mutations either by base pair substitution or by frame shifts in the genome of the strains used under the conditions of the assay with and without metabolic activation.
- Executive summary:
The study used as source investigated the genotoxicity of Hostavin 3055.The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- In conclusion it is stated that during the mutagenicity test described and under the experimental conditions reported the source substance did not induce mutations in the HPRT locus in V79 cells of the Chinese hamster in the absence and presence of metabolic activation.
- Executive summary:
The study used as source investigated the genotoxicity of Hostavin 3055.The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
Referenceopen allclose all
Additional information on results
Solubility Record |
||
Solvent used |
RO (reverse osmosis) Water |
Dimethyl sulfoxide |
Quantity of test item |
50 mg |
50 mg |
Volume of vehicle added |
1000 µL |
1000 µL |
Final Concentration |
50 mg /mL |
50 mg /mL |
Solubility status |
Insoluble |
Soluble |
As mentioned in the above table, solubility of test item was checked in RO water and found insoluble. So the solubility was checked in Dimethyl sulfoxide (DMSO). The test item was found soluble in DMSO at 50 mg/ml to give final treatment concentration of 5 mg/plate (recommended maximum test concentration for soluble non-cytotoxicity substances). Therefore, DMSO was chosen as solvent for the study.
Precipitation
Precipitation was checked as insolubility to assess precipitation in the final mixture under the actual test conditions and evident to the unaided eye. Test item dissolved in DMSO at 50 mg/mL concentration was checked for precipitation. Details are given in table below:
Precipitation Record |
|||
Overlay agar volume |
Test item preparation volume |
Concentration/Plate |
Result |
2 mL |
100 µL |
5 mg |
No Precipitation |
An amount of test item preparation (50 mg/mL) was added 2 ml of overlay agar (Top agar) in test tubes to give test item concentration of 5 mg/plate and plated on minimal glucose agar (MGA) plates. Precipitation was not observed. Therefore, 5 mg/plate was selected as the highest concentration for pre-experiment.
Range-Finding/Screening studies
The pre-experiment was performed with TA 100 and TA 98 strain ofSalmonella typhimuriumand with eight different concentrations of the test item prepared with half log intervals and three plates were used for each dose level and for the controls. 5 mg/plate were selected as the highest dose in the pre-experiment basedon the solubility and precipitation test. Following doses were selected for the pre-experiment i.e., 0.001, 0.002, 0.005, 0.016, 0.050, 0.501, 1.582 and 5 mg/plate.
The results were evaluated based on the reduction of revertant colony count and bacterial background lawn.
Toxicity was observed in the tested concentrations 5 (T8) and 1.582 (T7) mg/plate. Reduction in colony count and microcolonies were observed in the tested concentrations 0.501 (T6) and 0.050 (T5) mg/plate both in absence and in the presence of metabolic activation. At treated concentrations 0.016 (T4) to 0.001 (T8) mg/plate, no reduction in colony count and background lawn were observed both in absence and in the presence of metabolic activation, when compared to that of the negative control group.
Based on the results of pre-experiment, following doses were selected for the main study trials: 0.0002, 0.001, 0.002, 0.005 and 0.016 mg/plate both in absence (-S9) and in the presence (+S9) of metabolic activation.
Comparision with Historical Control Data
The spontaneous reversion rates in the negative control are in the range of in house historical data.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Hostavin 3058 was assessed for its potential to induce micronuclei in NMRI mice in vivo. The test item did not induce micronuclei when tested at the limit dose of 2000 mg/kg bw.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG, B.12 (Mikrokerntest); OECD 474
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- other: BOR:NMRI (SPF Han.)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 41 male, 41 female mice
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- Limit test
- Frequency of treatment:
- once
- Post exposure period:
- 24 and 48 h
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
- Control animals:
- yes
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): commonly accepted
- Route of administration: gavage
- Doses / concentrations: 100 mg/kg bw - Tissues and cell types examined:
- bone mark from femurs
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: MTD derived from pretest
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): single application; sample times: 24 and 48 h after treatment
DETAILS OF SLIDE PREPARATION:
Cell suspension was washed by cellulose-chromatography, centrifuged and resuspended in FBS/EDTA. Slide preparation per animal, 24 h drying and staining with May-Grünwald/Giemsa solution.
METHOD OF ANALYSIS:
Analysis by application of "Micronucleus Test V 4.00", Leitz MIAMED)
OTHER:
anaylsis of min. 2000 PCE
- PCE/NCE ratio
- frequency of micro nuclei in polychrmoatic and normochromatic erythrocytes - Statistics:
- Application of "Statgraphics, Version 5.0" (Statistical Graphics Corporation)
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Additional information on results:
- Observations:
No statistically significant increase in number of polychromatic erythrocytes.
No cytotoxicity observed (PCE/NCE). - Conclusions:
- Interpretation of results (migrated information): negative
Under the test conditions described above, the test substance showed to be non-mutagenic. - Executive summary:
The mutagenic potential of the test substance was investigated in an in vivo mouse micronucleus tests according to OECD Guideline 474. In this test, the substance showed to be non-mutagenic.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Mode of Action Analysis / Human Relevance Framework
In the absence of any information on species specific activities or mode of actions the results are regarded as relevant for humans
Additional information
Hostavin 3058 and its structural analogue showed negative results in three studies for the induction of gene mutations (bacterial reverse mutation assay) by frameshift or base-pair substitutions with and without metabolic activation. The study was performed with the test strainsS. typhimuriumTA 98, TA 100, TA 1535, TA 1537 andTA 102. Test concentrations up to the limit concentration of 5000 µg/plate were tested in the experiment. The test compound proved to be not mutagenic to the bacterial strains.
The structural analogue; Hostavin 3055, also yielded negative results in anin vitrogene mutation study in mammalian cells with and without metabolic activation. Additionally, negative results were obtained in an in vivo micronucleus assay in mice at the limit dose of 2000 mg/kg bw.
Justification for classification or non-classification
Hostavin 3058 does not have to be classified as mutagenic according to Regulation (EC) No. 1272/2008 since neither this substance nor it's structural analogue Hostavin 3055 did reveal any mutagenic effect in the available assays.
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