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EC number: 261-596-8 | CAS number: 59086-80-5
- 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
No measured data are available to assess the in vitro bacterial mutagenicity potential of the registered substance, however, reliable data are available for the structurally analogue substances trichloro(hexadecyl)silane (CAS 5894-60-0), dichloromethyloctylsilane (CAS 14799-93-0), and hexadecyltrimethoxysilane (CAS 16415-12-6).
Bacterial Mutagenicity: RA to CAS 5894 -60 -0, CAS 16415 -12 -6, CAS 14799 -93 -0: negative
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:
- weight of evidence
- Justification for type of information:
- Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- experiment I: at 1000 µg/plate (TA 100, TA 1535, TA 1537 without S9-mix; TA 1537 with S9-mix); experiment II: at 316 and 1000 µg/plate (all strains, without S9-mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 316 and 1000 µg/plate (without S9-mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- experiment I:at 1000 µg/plate (all strains, with and without S9-mix); experiment II: at 1000 µg/plate (all strains, without S9-mix); at 316 µg/plate (TA 98, TA 1535. TA 1537, without S9-mix), =316 µg/plate (all strains, with S9-mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- experiment I: at 1000 µg/plate (with and without S9-mix); experiment II: =316 µg/plate (with and without S9-mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: CAS 5894-60-0, LPT, 2002
- Conclusions:
- Interpretation of results: negative
Source substances trichloro(hexadecyl)silane (CAS 5894-60-0), hexadecyl(trimethoxy)silane (CAS 16415-12-6) and dichloromethyloctylsilane (CAS 14799-93-0) have been tested in compliance with OECD 471, under GLP conditions. No increase in the number of revertant colonies compared with the solvent control was observed for the source substances in any of the Salmonella typhimurium strains TA98, TA 100, TA102, TA 1535 and TA 1537 and/or E. coli WP2 uvr A when tested with and without metabolic activation in either the initial plate incorporation or the repeat experiment. It is concluded that the source substances are negative for mutagenicity to bacteria under the conditions of the test. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in genetic toxicity potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
There are no data available on genetic toxicity of dichloromethyltetradecylsilane (CAS 59086-50-5). In order to fulfil the standard information requirements set out in Annex VII, 8.4., in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted. In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Overview of genetic toxicity
CAS |
Chemical name |
Molecular weight [g/mol] |
Gene mutation in vitro (Ames) |
59086-80-5 (a) |
Dichloromethyltetradecylsilane |
311.41 |
RA: CAS 5894 -60 -0 RA: CAS 16415-12-6 RA: CAS 14799-93-0 |
5894-60-0 (b) |
Trichloro(hexadecyl)silane |
359.88 |
Experimental result: negative |
16415-12-6 (b) |
Hexadecyltrimethoxysilane |
346.62 |
Experimental result: negative |
14799-93-0 (b) |
Dichloromethyloctylsilane |
227.25 |
Experimental result: negative |
(a) The substance subject to registration is indicated in bold font.
(b) Reference (read-across) substances are indicated in normal font.
The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Dichloromethyltetradecylsilane (CAS 59086-80-5). Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
Discussion
No data on genetic toxicity (mutagenicity) in bacteria cells is available with Dichloromethyltetradecylsilane (CAS 59086-80-5). Therefore, read across from the structurally analogue substances Trichloro(hexadecyl)silane (CAS 5894-60-0), Hexadecyltrimethoxysilane (CAS 16415-12-7) and Dichloromethyloctylsilane (CAS 14799-93-0) was applied.
Genetic toxicity (mutagenicity) in bacteria in vitro
CAS 5894-60-0
A reliable bacterial reverse mutation study conducted according to OECD TG 471 and in compliance with GLP is available for trichloro(hexadecyl)silane (CAS 5894-60-0) (LPT, 2002). The strains Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 were tested according to the plate incorporation (experiment I) and pre-incubation (experiment II) procedure in the absence and presence of a metabolic activation system (Aroclor-induced rat liver S9-mix). Two independent experiments were conducted in three repetitions at each concentration from 10 to 1000 µg/plate (experiment I and II). Cytotoxicty was recorded at 1000 µg/plate for the tester strains TA 100, TA 1535, TA 1537, TA 102 (experiment I, without S9-mix) and for tester strain TA 1537 (experiment I with S9-mix). In the second experiment cytotoxicity was observed at concentrations of 316 and 1000 µg/plate for all tester strains without metabolic activation. Appropriate solvent (ethylene glycol dimethylether) and positive controls were included and gave the expected results. No significant increase in the number of revertants was observed in any of the tester strains with and without metabolic activation. Based on the results the test material was considered to be not mutagenic to bacteria under the conditions of the tests.
CAS 14799-93-0
Another reliable bacterial gene mutation study (Ames test) performed according to OECD TG 471 and in compliance with GLP with dichloromethyloctylsilane (CAS 14799-93-0) is available (LPT, 2002). The strains Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 were tested according to the plate incorporation (experiment I) and pre-incubation (experiment II) procedure in the absence and presence of a metabolic activation system (Aroclor-induced rat liver S9-mix). Two independent experiments were conducted in three repetitions each at concentrations from 10 to 1000 µg/plate (experiment I and II). Cytotoxicity was observed in all tester strains in the first experiment carried out with and without metabolic activation at the highest concentration of 1000 µg/plate. Moreover, cytotoxicity was recorded in all tester strains in the second experiment carried out without metabolic activation at the highest concentration of 1000 µg/plate and for TA 98, TA 102, TA 1535 and TA 1537 at a concentration of 316 µg/plate. Cytotoxicity was recorded for all tester strains in the second experiment (with metabolic activation) at concentrations of 316 and 1000 µg/plate. Precipitation was recorded at the highest concentration of 1000 µg/plate in the first experiment (with and without metabolic activation) and at 316 and 1000 µg/plate in the second experiment (with and without metabolic activation). Appropriate solvent (ethylene glycol dimethylether) and positive controls were included and gave the expected results. No significant increase in the number of revertants was observed in any of the tester strains with and without metabolic activation. Based on the results the test material was considered to be not mutagenic to bacteria under the conditions of the tests.
CAS 16415-12-6
Another reliable bacterial gene mutation study (Ames test) performed according to OECD TG 471 and in compliance with GLP with hexadecyltrimethoxysilane (CAS 16415-12-6) is available (Evonik, 2011). The strains Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA were tested according to the plate incorporation (experiment I-III) procedure in the absence and presence of a metabolic activation system (Aroclor-induced rat liver S9-mix). Three independent experiments were conducted in three repetitions at concentrations from 62 to 5000 µg/plate (experiment I + II) and 1000 to 5000 µg/plate (experiment III) with and without metabolic activation. No cytotoxicity was observed in any tester strains at any concentration. Precipitation of the test material was recorded at concentrations =1000 µg/plate. Appropriate solvent (acetone) and positive controls were included and gave the expected results. No significant increase in the number of revertants was observed in any of the tester strains with and without metabolic activation. Based on the results the test material was considered to be not mutagenic to bacteria under the conditions of the tests.
Taking into consideration the above results generated from the structurally analogue substances the target substance Dichloromethyltetradecylsilane (CAS 59086-80-5) is not expected to be mutagenic to bacteria.
Justification for classification or non-classification
Based on the available data on genetic toxicity of the structurally analogue substances the registered substance is not considered to induce genetic toxicity in bacteria. However, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 can be made, as no information on chromosomal aberration and mutagenicity in mammalian cells/in vivo is available.
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.
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