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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Reference
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

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.

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.

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
Reference
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

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

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.

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.