Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 284-461-5 | CAS number: 84896-44-6
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 18th August 1992 - 16th October 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results. Read across from DBT-2EHMA (CAS: 10584-98-2)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- TK 11638 (Irgastab T 22 M)
- IUPAC Name:
- TK 11638 (Irgastab T 22 M)
- Details on test material:
- - Name of test material (as cited in study report): TK 11638
- Trade Name: Irgastab 22M
- Substance type: Organotin
- Physical state: Liquid
- Identity Main component: Di-n-butyltin bis (2-ethylhexylthioglycolate)
- Purity: 65 %
- Impurities (identity and concentrations): 35 % Mono-n-butyltin tris (2-ethylhexylthioglycolate)
- Reanalysis date: July 1996
- Storage condition of test material: NDA
Constituent 1
Method
- Target gene:
- Salmonella typhimurium: histidine operon
Escherichia coli: tryptophan operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arcolor 1254 induced Rat liver S9-mix
- Test concentrations with justification for top dose:
- Mutagenicity Test, original experiment: 625.0000, 1250.0000, 2500.0000 and 5000.0000 µg/plate
Mutagenicity Test, first confirmatory experiment: 39.0625, 78.1250, 156.2500, 312.5000, 625.0000 µg/plate
Mutagenicity Test, second confirmatory experiment: 4.8828, 9.7656, 19.5313, 39.0625 µg/plate - Vehicle / solvent:
- - Vehicle used: acetone
- Justification for choice of vehicle: NDA
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: See information on methods section.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation).
DURATION
- Preincubation period: Inoculates from frozen master copies were set up monthly. They were grown in liquid nutrient broth medium (NB-medium) overnight and then plated on NB-agar.
- Exposure duration: 48 h
CONTROL OF THE GENOTYPE OF THE STRAINS
The characteristics of the strains were checked monthly. Histidine-auxotrophy of the Salmonella strains was demonstrated by the requirement for L-histidine. The presence of the rfa character was assayed by the sensitivity for crystal-violet. The deletion of the uvrB gene was demonstrated by the sensitivity for UV-light. The Salmonella strains containing the R-factor (TA 98 and TA 100) were additionally checked for ampicillin resistance. The tryptophan-auxotrophy of E.coli WP2 uvrA was demonstrated by the requirement for tryphophan. The absence of the uvrA gene was demonstrated by the sensitivity of the strain for UV-light. Furthermore, all strains were checked for their characteristic reversion properties with known mutagens (positive controls).
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: Number of revertant colonies detrected by an Artek computer - Evaluation criteria:
- The test substance is considered to be mutagenic in this test system if:
- A positive effect is observed in one strain and the effect can be reproduced in a confirmatory experiment.
- A positive effect is observed in two or more strains.
A positive effect is defined as an increase of the mean number of revertants per plate for any concentration above that of the negative control by at least a factor of 2.0 with strains TA 98, TA 1535, TA 1537 and WP2 uvrA, or by a factor of at least 1.5 with strain TA 100. Generally a concentration related effect should be demonstrable. If equivocal results are obtained, the final decision has to be based on scientific judgement. - Statistics:
- Means and standard deviations for all mutagenicity assays were calculated by a previously validated computer program.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- 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
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Six concentrations of TK 11638 ranging from 20.6 to 5000 µg/plate were tested with strains S. typhimurium TA 100 and E. coli WP2 uvrA to determine the highest concentration to be used in the mutagenicity assay. The experiments were performed without and with metabolic activation. Normal background growth was observed with both strains. The numbers of revertant colonies were not reduced. From the results obtained, the highest concentration suitable for the first mutagenicity test was selected to be 5000 µg/plate with and without metabolic activation. - Remarks on result:
- other: other: Preliminary cytogenicity test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of these experiments and on standard evaluation criteria, it is concluded that TK 11638 (Irgastab T 22 M) and its metabolites did not induce gene mutations in the strains of S. typhimurium and E. coil used. - Executive summary:
The results of the Salmonella - Escherichia coli/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory Assay indicate that under the conditions of this study, in both initial and confirmatory assays, the test article, TK 11638, did not cause a positive increase in the numbers of revertants per plate of any of the tester strains either in the presence or absence of microsomal enzymes prepared from induced rat liver (S9).
Read across from DBT-2EHMA (CAS: 10584-98-2)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
