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EC number: 248-595-8 | CAS number: 27668-52-6
- 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
Repeated dose toxicity oral:
Repeated oral toxicity test was performed By Siddiqui and York (1993) in virgin female Sprague-Dawley derived Charles River CD rats using different concentrations of Quaternary Silsequioxane as 0,100, 300 or 1000 mg/kg/day. Adult virgin female Sprague-Dawley rats were taken, mated with male and evidence of mating was detected and designated as Day 0 of gestation. Including control in all groups 25 rats were taken for treatment at each dose level. Doses were given orally from Days 6 through 15 at a constant volume of 10 ml/kg. Mortality, clinical signs, organ weight and fetuses were observed in maternal rats. No mortality was observed in study, no changes in clinical signs and behavior were observed. Mean body weight gains and feed consumption in treated animals were not affected during the study when compared to those of the control group. A slight but significant increase in relative liver-to- body- weight ratio was observed at the 1000 mg/kg/day dose level. Based on the result observed for maternal rats on mortality, clinical signs and Organ weight it was determined that the Quaternary Silsesquioxane (27668-52-6) has a No Observed Adverse Effect Level (NOAEL) of 300 mg /kg/day concentration.
Repeated dose toxicity dermal:
Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of N,N-dimethyl-N-[3-(trimethoxysilyl)propyl]octadecan-1-aminium chloride using Sustainability Support Services Quantitative Structure Activity Relation prediction database, 2017. The study assumed the use of male and female New Zealand White rabbits in a subchronic study performed. The No Observed Adverse Effect Level (NOAEL) for N,N-dimethyl-N-[3-(trimethoxysilyl)propyl]octadecan-1-aminium chloride is found to be 792.0 mg/Kg bw/day using New Zealand White rabbits and hence is predicted to not classify as a toxicant by repeated dermal route of exposure.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed publication
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Repeated dose oral toxicity study was performed to determine the toxic nature of Quaternary Silsesquioxane according to The Federal Insecticide,
Fungicide, and Rodenticide Act (F1FRA) Good Laboratory Practice Standards (U.S. EPA, 1989). - GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories Inc. (Portage, MI)
- Age at study initiation: Adult virgin, 13 weeks of age when paired for mating
- Weight at study initiation: 206 to 275 g at gestation day 0
- Fasting period before study: No data available
- Housing: The females rats were housed individually in suspended stainless steel wire mesh cages from receipt until sacrifice except during the period of mating
- Diet (e.g. ad libitum): Certified Rodent Chow 5002 (Ralston Purina Co., St. Louis, MO) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64-69°F (17.8 - 20.5 °C)
- Humidity (%):Relative humidity: 30-70%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): Light cycle of 12 hrs
IN-LIFE DATES: From: To: No data available - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test article was suspended fresh daily in corn oil to give a dose range of 0, 100, 300, and 1000 mg/kg/day
DIET PREPARATION
- Rate of preparation of diet (frequency): Daily
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Corn oil
- Concentration in vehicle: 0, 100, 300, and 1000 mg/kg/day
- Amount of vehicle (if gavage): 10 ml/kg
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 10 days (From gestation days 6 to 15)
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
0, 100, 300, and 1000 mg/kg/day
Basis:
other: Dosage levels were selected from the results obtained in a range-finding developmental toxicity study. - No. of animals per sex per dose:
- Total: 100
0 mg/Kg/day: 25 females rats
100 mg/Kg/day: 25 females rats
300 mg/Kg/day: 25 females rats
1000 mg/Kg/day: 25 females rats - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dosage levels were selected from the results obtained in a range-finding developmental toxicity study. In that study neither maternal nor developmental toxicity was seen at dosage levels of up to 1000 mg/kg/ day.
- Rationale for animal assignment (if not random): Mated females were assigned consecutively, in the order the mating was detected, to one control and three treatment groups consisting of 25 rats
- Rationale for selecting satellite groups: No data
- Post-exposure recovery period in satellite groups: No data
- Section schedule rationale (if not random): No data - Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations checked in table [No.?] were included. For mortality and overt changes in appearance and behavior.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily on Gd 6 to 20
BODY WEIGHT: Yes
- Time schedule for examinations: daily on Gestation Days 0,6,9, 12, 16, and 20
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, daily on Gestation Days 0,6,9, 12, 16, and 20
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY:
- Time schedule for collection of blood: No data available
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
CLINICAL CHEMISTRY: No data available
- Time schedule for collection of blood: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
URINALYSIS: No data available
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined.: No data available
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available
OTHER: No data available - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, Immediately following sacrifice on Day 20 of gestation, the uterus was excised, gravid uterine weight was recorded, the fetuses were removed, and pertinent developmental endpoints were recorded. Maternal liver weights and postmortem body weights were recorded. Individual fetuses were weighed, measured (crown-rump length), sexed, and examined for external malformations and developmental variations.
HISTOPATHOLOGY: Yes, Uteri from females that appeared nongravid were opened and placed in 10% ammonium sulfide solution for detection of implantations. One-half of the fetuses were placed in Bouin's solution for subsequent soft tissue examination using the Wilson razor blade technique, and the remaining half of the fetuses were fixed in alcohol, macerated in potassium hydroxide, stained with Alizarin Red-S, and cleared with glycerin for subsequent skeletal examination. - Other examinations:
- No data
- Statistics:
- 1)Mean maternal body weights and liver weights, maternal feed consumption, numbers of corpora lutea, total implantations, live fetuses, gravid uterine weight, and mean fetal body weights were compared by one-way analysis of variance (ANOVA), Bartlett's test for homogeneity of variance, and the appropriate test for equal and unequal variance (Steel and Torrie, 1960) using Dunnett's multiple comparison.
2) The proportions of resorbed and dead fetuses and postimplantation losses were compared by the Mann-Whitney t/test.
3) Male to female fetal sex ratios and the proportions of litters with malformations and developmental variations were compared using the x2 test criterion with Yate's correction for 2 X 2 contingency tables and/or Fisher's exact probability test. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Clinical signs and mortality:
Clinical signs: No compound related clinical sign was observed in dams.
Mortality: No maternal mortality was observed that could be compound related.
Body weight and weight gain: Mean body weight was not affected during study as compared to control. Mean corrected body weights (terminal body weight minus gravid uterine weight) were comparable between the treated and control groups. increase as liver to body weight ratio at highest dose when compare to control.
Food consumption and compound intake: Feed consumption was not affected during study as compared to control.
Food efficiency: No data available
Water consumption and compound intake: No data available
Opthalmoscopic examination: No data available
Haematology: No data available
Clinical chemistry: No data available
Urinanalysis: No data available
Neurobehaviour: No data available
Organ weights: A slight but significant increase in relative liver-to-body-weight ratio was observed at the 1000 mg/kg/day dose level and was considered treatment-related. Maternal Liver weight and postmortem body weights were recorded.
Gross pathology: No data available
Histopathology: No data available - Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: clinical signs; mortality; body weight; food consumption
- Critical effects observed:
- not specified
- Conclusions:
- Based on the result observed for maternal rats on mortality, clinical signs and organ weight, Quaternary Silsesquioxane (27668-52-6) has a No Observed Adverse Effect Level (NOAEL) of 300 mg /kg/day concentration.
- Executive summary:
Repeated oral toxicity test was performed in virgin female Sprague-Dawley derived Charles River CD rats using different concentrations of Quaternary Silsequioxane as 0,100,300 or 1000 mg/kg/day. Adult virgin female Sprague-Dawley rats were taken, mated with male and evidence of mating was detected and designated as Day 0 of gestation. Including control in all groups 25 rats were taken for treatment at each dose level. Doses were given orally from Days 6 through 15 at a constant volume of 10 ml/kg. Mortality, clinical signs, organ weight and fetuses were observed in maternal rats. No mortality was observed in study, no changes in clinical signs and behavior were observed. Mean body weight gains and feed consumption in treated animals were not affected during the study when compared to those of the control group. A slight but significant increase in relative liver-to- body- weight ratio was observed at the 1000 mg/kg/day dose level. Based on the result observed for maternal rats on mortality, clinical signs and organ weight, the Quaternary Silsesquioxane (27668-52-6) has a No Observed Adverse Effect Level (NOAEL) of 300 mg /kg/day concentration.
Reference
Table: Summary of Maternal Body Weight Gain, Food Consumption, and Liver Weights
Dose level Mg/kg/day |
0 |
100 |
300 |
1000 |
Gestation day |
||||
|
Mean Body weight change |
|||
0-6 |
26 ± 7* |
25 ±7 |
27 ± 7 |
29 ±8 |
6-9 |
3 ± 8 |
3 ± 8 |
7±7 |
6 ± 8 |
9-12 |
16 ± 10 |
19 ±6 |
15 ± 4 |
15 ± 9 |
12-16 |
27 + 7 |
26 ± 12 |
22 ± 8 |
22 ± 11 |
16-20 |
59 ± 11 |
61 ± 17 |
62 ± 13 |
60 ± 15 |
0-20 |
131 ± 19 |
133 ±25 |
132 ± 19 |
132 ±25 |
0-20 adjusted |
61 + 13 |
62 ± 14 |
62+13 |
66 ± 13 |
|
Mean food consumption (g/dam/day) |
|||
0-6 |
21.5 + 2 |
21.5 ±2 |
22.3 ±2 |
22.0 ± 4 |
6-9 |
17.8 ± 4 |
15.2 ±3* |
17.9 ± 3 |
19.9 ± 8 |
9-12 |
17.9 ± 2 |
17.9 ± 2 |
19.9 ±3* |
21.2 ± 8 |
12-16 |
19.8 ± 2 |
21.1 ± 5 |
20.4 ± 3 |
20.2 ± 4 |
16-20 |
27.3 ± 2 |
27.4 ± 3 |
26.2 ± 6 |
28.0 ± 2 |
0-20 |
21.3±1 |
21.2 ± 2 |
21.7 ± 2 |
22.5 ± 3 |
|
Mean maternal liver weight |
|||
Absolute (g) |
15.4 + 2.9 |
15.3 ±2.9 |
16.1 ±2.6 |
16.5 ±2.5 |
Relative (g) |
4.4 ± 0.4 |
4.4 ± 0.3 |
4.5 ±0.3 |
4.6 ± 0.2* |
* Significantly different from controls; ANOVA, Welch Test, P < 0.05.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Data is from peer reiviewed publication
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data is from Sustainability Support Services Quantitative Structure Activity Relation prediction database and the supporting QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 3.4
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material: Dow Corning Q9-5700
- Molecular formula: C26H58NO3Si.Cl
- Molecular weight: 496.287 g/mole
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): No data - Species:
- rabbit
- Strain:
- New Zealand White
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on exposure:
- No data
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 792 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects were noted at the mentioned dose level
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for N,N-dimethyl-N-[3-(trimethoxysilyl)propyl]octadecan-1-aminium chloride is found to be 792.0 mg/Kg bw/day using New Zealand White rabbits and hence is predicted to not classify as a toxicant by dermal route of exposure.
- Executive summary:
Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of N,N-dimethyl-N-[3-(trimethoxysilyl)propyl]octadecan-1-aminium chloride using Sustainability Support Services Quantitative Structure Activity Relation prediction database, 2017. The study assumed the use of male and female New Zealand White rabbits in a subchronic study performed. The No Observed Adverse Effect Level (NOAEL) for N,N-dimethyl-N-[3-(trimethoxysilyl)propyl]octadecan-1-aminium chloride is found to be 792.0 mg/Kg bw/day using New Zealand White rabbits and hence is predicted to not classify as a toxicant by repeated dermal route of exposure.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
((((("a"
or "b" or "c" )
and ("d"
and (
not "e")
)
)
and ("f"
and (
not "g")
)
)
and ("h"
and (
not "i")
)
)
and ("j"
and "k" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Alkoxysilanes AND Cationic
(quaternary ammonium) surfactants by US-EPA New Chemical Categories
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Reactive unspecified by Acute
aquatic toxicity MOA by OASIS
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Quaternary organic ammonium
compounds by Skin irritation/corrosion Inclusion rules by BfR
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OASIS v.1.3
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Radical OR Radical >> Radical
mechanism via ROS formation (indirect) OR Radical >> Radical mechanism
via ROS formation (indirect) >> Single-Ring Substituted Primary Aromatic
Amines OR SN1 OR SN1 >> Nucleophilic attack after metabolic nitrenium
ion formation OR SN1 >> Nucleophilic attack after metabolic nitrenium
ion formation >> Single-Ring Substituted Primary Aromatic Amines OR SN2
OR SN2 >> DNA alkylation OR SN2 >> DNA alkylation >> Alkylphosphates,
Alkylthiophosphates and Alkylphosphonates by DNA binding by OASIS v.1.3
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Not categorized by Repeated dose
(HESS)
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Thiocarbamates/Sulfides
(Hepatotoxicity) No rank by Repeated dose (HESS)
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Not possible to classify
according to these rules (GSH) by Protein binding potency
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as Highly reactive (GSH) OR Highly
reactive (GSH) >> Acrylates (MA) by Protein binding potency
Domain
logical expression index: "j"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 1.14
Domain
logical expression index: "k"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 5.63
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Dose descriptor:
- NOAEL
- 792 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rabbit
- Quality of whole database:
- Data is from prediction database
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data from peer reviewed publications were reviewed to determine the toxic nature of Quat-Silsesquioxane. The summary is as mentioned below:
Repeated dose toxicity oral:
Repeated oral toxicity test was performed By Siddiqui and York (1993) in virgin female Sprague-Dawley derived Charles River CD rats using different concentrations of Quaternary Silsequioxane (CAS no 27668 -52 -6) as 0,100, 300 or 1000 mg/kg/day. Adult virgin female Sprague-Dawley rats were taken, mated with male and evidence of mating was detected and designated as Day 0 of gestation. Including control in all groups 25 rats were taken for treatment at each dose level. Doses were given orally from Days 6 through 15 at a constant volume of 10 ml/kg. Mortality, clinical signs, organ weight and fetuses were observed in maternal rats. No mortality was observed in study, no changes in clinical signs and behavior were observed. Mean body weight gains and feed consumption in treated animals were not affected during the study when compared to those of the control group. A slight but significant increase in relative liver-to- body- weight ratio was observed at the 1000 mg/kg/day dose level. Based on the result observed for maternal rats on mortality, clinical signs and Organ weight it was determined that the Quaternary Silsesquioxane (27668-52-6) has a No Observed Adverse Effect Level (NOAEL) of 300 mg /kg/day concentration.
Repeated dose toxicty Inhalation: Waiver
A short term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment.
Aggregate Risk: The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic Act require “that there is a reasonable certainty that no harm will result from aggregate exposure to pesticide chemical residue, including all anticipated dietary exposures and other exposures for which there are reliable information”. Aggregate exposure will typically include exposures from food, drinking water, residential uses of a pesticide and other non-occupational sources of exposure. Residential exposure to the 3-(Trimethoxysilyl)propyldimethyloctadecylammonium is likely; however there are no toxicological endpoints of concern. An aggregate risk assessment was therefore not conducted for this chemical.
Occupational Exposure: The occupational exposure assessment addresses potential exposures and risks to humans who may be exposed in “occupational settings.” An occupational risk assessment is required for an active ingredient if certain toxicological criteria are triggered and there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. For the 3-(Trimethoxysilyl)propyldimethyloctadecylammonium there is potential for exposure; however, there are no toxicological endpoints of concern.
Repeated dose toxicity dermal:
Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of N,N-dimethyl-N-[3-(trimethoxysilyl)propyl]octadecan-1-aminium chloride (CAS no 27668 -52 -6) using Sustainability Support Services Quantitative Structure Activity Relation prediction database, 2017. The study assumed the use of male and female New Zealand White rabbits in a subchronic study performed. The No Observed Adverse Effect Level (NOAEL) for N,N-dimethyl-N-[3-(trimethoxysilyl)propyl]octadecan-1-aminium chloride is found to be 792.0 mg/Kg bw/day using New Zealand White rabbits and hence is predicted to not classify as a toxicant by repeated dermal route of exposure.
Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of Dow Corning Q9-5700 (CAS no 27668 -52 -6). The study employed a fabric (nonwoven polyester) treated with Dow Corning Q9-5700 antimicrobial agent at 0, 0.5% or 5.0% w/w (0, 151.5 or 1515.15 mg/Kg bw/day)
. Approximately 60 square inches of fabric was allowed to contact the shaved back and abdomen of the rabbits for 6 hrs/day, 5 days/week for 4 weeks (20 applications). The skin of each rabbit was premoistened with normal saline to simulate perspiration. After the 6-hour contact period, the fabrics were removed, rinsed with tap water and patted dry. No significant untoward alterations were observed with regards to mortality, reactions, effects on body weight, hematologic and clinical chemistry parameters, urine analysis, gross and microscopic pathologic examinations among any of the tested animals. The No Observed Adverse Effect level (NOAEL) for Dow Corning Q9-5700 is found to be 5.0 % w/w when applied to shaved back and abdomen of rabbits.
Based on the data available, the test material Quat-Silsesquioxane is not likely to be toxic upon repeated exposure by oral and dermal route of exposure.
Justification for classification or non-classification
Based on the data available, the test material Quat-Silsesquioxane is not likely to be toxic upon repeated exposure by oral and dermal route of exposure.
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