Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 260-350-7 | CAS number: 56706-10-6
- 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
Endpoint summary
Administrative data
Description of key information
The key study for acute oral toxicity reports an LD50 value of greater than 2150 mg/kg bw for 4,4,13,13 -tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane ("S2"; CAS No. 56706-10-6, EC No. 260-350-7) conducted according to OECD Test Guideline 401 and in compliance with GLP (ASTA Medica AG, 1996).
The key read-across acute inhalation toxicity study with bis[3-(triethoxysilyl)polysulfides (“polysulfides”; CAS No. 211519-85-6, EC No. 915-673-4) was conducted according to OECD Test Guideline 403 but pre-dated GLP. In this study, a polysulfides LC50 of at least 7967 mg/m3 in rats exposed for 4 hours was identified. No deaths were reported and clinical signs were minor and transient (RCC Ltd, 1983).
The key study for acute dermal toxicity was conducted with low purity S2, in which an S2 LD50 value of greater than 2000 mg/kg bw was determined. The study was conducted according to OECD Test Guideline 402 and in compliance with GLP (WIL, 2000).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 150 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 13 to 27 Jan 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: outbred Wistar stock, (kfm:Wistar)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf, SWITZERLAND
- Age at study initiation: 9 weeks (males), 12 weeks (females)
- Weight at study initiation: 229-268 g (males), 217-272 g (females)
- Fasting period before study: apparently none - food withheld during treatment
- Housing: 5/Macrolon type 4 cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h
IN-LIFE DATES: From: 1983-01-13 To: 1983-01-27 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: PVC nose-only tube-shaped chambers arranged radially around central chamber.
- Exposure chamber volume: 100 l
- Method of holding animals in test chamber: not stated
- Source and rate of air: dynamic, 10 l/min (operated as described in Sachsse et al 1973 & 1976).
- Method of conditioning air: -
- System of generating particulates/aerosols: test material supplied to spray nozzle by Perfusor R ED 1-300 automatic infusion pump. Air flow 600 l/hr; air pressure 3 atmospheres.
- Method of particle size determination: gravimetric (4-stage cascade impactor on Selectron filter)
- Treatment of exhaust air: -
- Temperature, humidity, pressure in air chamber: 22.5° C (SD 0.4); 57% RH (SD 9)
- Oxygen level: 20 % vol
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric (Selectron filter pore size 0.2 microns)
- Samples taken from breathing zone: not stated
VEHICLE
none
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 46% 1-7 microns (2 measurements) - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric
- Duration of exposure:
- 4 h
- Concentrations:
- 7967 mg/m3 (measured) (standard deviation 510)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: mortality and clinical observations 5 times during day 1, then daily; body weights recorded on days 1, 8, 15.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight. - Statistics:
- None.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 7 967 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: standard deviation 510 mg/m3
- Mortality:
- No deaths. See table 1.
- Clinical signs:
- other: Minor clinical signs reported during day 1. See table 1.
- Body weight:
- No effect on body weight.
- Gross pathology:
- No treatment-related effects reported.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a reliable study conducted according to OECD Test Guideline 403 but without indication of compliancy to GLP, an LC50 in excess of 7967 mg/m3 in rats exposed for 4 h was identified.
Reference
Table 1: Concentrations, exposure conditions and mortality or evident toxicity
Nominal Conc. (ml/h) |
Analytical Conc. (mg/m3) |
Mean particle size distribution µm |
Mortality (males and females/total) |
Number with evident toxicity (males and females/total) |
60 |
7967 (SD 510) |
46% 1-7 |
0/10 |
Day 1: slight dyspnoea, slight exophthalmos or slightly ruffled fur in all exposed animals. Days 2-15: no overt toxicity |
0 |
0 |
- |
no data |
- |
SD: standard deviation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 7 967 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 23 Nov 1999 to 7 Dec 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP. The test material was similar to the registered substance but contained a higher proportion of an S3 isomer. The original study and the read-across are considered to be reliability 2.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD(SD)IGS BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Labs, Raleigh, NC, USA
- Age at study initiation: 8 wk (m), 9 wk (f)
- Weight at study initiation: 293-315 g (m), 241-265 g (f)
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 71.4-72.1 deg F
- Humidity (%): 33.7-44.6
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1999-11-24 To: 1999-12-07 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: 18-23
- Type of wrap if used: gauze binder with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with moistened paper towel
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.94 ml/kg bw (1.03 g/ml) - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 (in dose groups)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations mortality twice daily, clinical changes daily, body weight days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- None given - limit test
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None.
- Clinical signs:
- other: No treatment-related effects.
- Gross pathology:
- No treatment-related effects detected.
- Other findings:
- Other observations: eschar (scabbing or sloughing) in 3/10, resolved by day 10; desquamation (shedding of skin) in 6/10, resolved by day 14. No erythema or oedema.- Interpretation of results:
- GHS criteria not met
- Conclusions:
- From a reliable study conducted in compliance with the standard guideline and in accordance with GLP, no mortality or systemic effects were seen at 2000 mg/kg bw. The test substance was similar to the registered substance but contained a higher proportion of an S3 isomer.
Reference
Table 1: Number of animals dead and with evident toxicity
Dose |
Mortality (# dead/total) |
Number with evident toxicity (#/total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
|
2000 |
0/5 |
0/5 |
0/10 |
No systemic toxicity only local effects reported |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Additional information
One key acute oral study is available for the registered substance S2 (ASTA Medica AG, 1996), conducted in a manner similar to (the now deleted) OECD Test Guideline 401 and in compliance with GLP. A single limit dose was administered to groups of male and female rats via gavage. No mortality or treatment-related effects were seen at 2150 mg/kg bw S2; the LD50 was identified as greater than this value.
A supporting study conducted according to OECD Test Guideline 401 for acute oral toxicity and in compliance with GLP was also available (WIL, 2000). The study was conducted with a low purity S2 and the results support the key findings. The LD50 was determined to be >2000 mg/kg bw.
No acute inhalation toxicity studies are available for the registered substance. The key read-across study for acute inhalation toxicity was conducted according to OECD Test Guideline 403 but pre-dated GLP (RCC, 1983). An LC50 greater than 7967 mg/m3 was determined for polysulfides in a 4-hour exposure to an aerosol of the registered substance. There were no mortalities or necroscopy findings. Minor clinical signs were reported during day 1, but these were more likely due to discomfort during the exposure procedure than indications of systemic toxicity. During the test study period there were no signs of overt toxicity. There were no effects on body weight, and gross pathology revealed no treatment related effects. Polysulfides is a multiconstituent reaction mass of the submission substance and two other polysulfide constituents (i.e., the trisulfide S3 and tetrasulfide S4). The three constituents are very similar in terms of structure and physicochemical and toxicological properties and so read-across is considered appropriate.
No acute dermal toxicity studies are available for the registered substance. A supporting read-across study for acute dermal toxicity with the related substance polysulfides was conducted largely in a manner similar to the OECD Test Guideline 402 but which pre-dated GLP. No mortality or systemic effects in rats treated at 4983 mg/kg bw was observed. Eschar was recorded in 8/10 animals, which resolved by day 13. No treatment-related abnormalities were reported at necropsy (Degussa Institute of toxicology, 1983). Thus, the dermal LD50 for polysulfides was at least 4983 mg/kg bw. The test material used in this dermal study contained a slightly higher proportion of S3 (see Section 1) than the registered material but this does not affect use of the data as no toxicological differences are expected between S2 and S3; this is discussed further in Section 7.8.
The substance in the read-across study with polysulfides
contained up to 25% of the registered substance. The other constituents
were the structurally similar analogue substances S3 and S4. The data
included as read across, from low purity S2 contained ca. 65% of the
registered substance. The other constituents were the structurally
similar S1 (monosulfide) and S3. Due to their structural similarity and
similar physicochemical properties, the read-across substances are
considered to be representative of the registered substance. See the
discussion of read across in the reproductive toxicity section endpoint
summary (Section 5.9 of the CSR) for a more detailed justification for
the read-across approach.
Justification for classification or non-classification
Based on the available substance-specific and read-across data, 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane does not require classification for acute toxicity according to Regulation (EC) No. 1272/2008.
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.