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EC number: 272-028-3 | CAS number: 68649-42-3
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- A Developmental Toxicity Study in Rats.
- Author:
- WAHEED H. SIDDIQUI et. al.
- Year:
- 1 993
- Bibliographic source:
- FUNDAMENTAL AND APPLIED TOXICOLOGY,1993
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride
- EC Number:
- 248-595-8
- EC Name:
- Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride
- Cas Number:
- 27668-52-6
- Molecular formula:
- C26H58NO3Si.Cl
- IUPAC Name:
- N,N-dimethyl-N-[3-(trimethoxysilyl)propyl]octadecan-1-aminium chloride
- Reference substance name:
- Quaternary Silsesquioxane
- IUPAC Name:
- Quaternary Silsesquioxane
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material:Quaternary Silsesquioxane
- Molecular formula : C26H58NO3Si.Cl
- Molecular weight:496.287 g/mol
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material:Quaternary Silsesquioxane
- Molecular formula : C26H58NO3Si.Cl
- Molecular weight:496.287 g/mol
- Substance type: Organic
- Physical state: Liquid
Test animals
- 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
Administration / exposure
- 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
Doses / concentrations
- Remarks:
- 0, 100, 300, and 1000 mg/kg/day
- 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
Examinations
- 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.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Clinical signs: No clinical sign was observed in dams.
- Mortality:
- no mortality observed
- Description (incidence):
- No maternal mortality was observed during the study.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weight and weight gain:
Mean body weight was not affected during study.
Mean corrected body weights (terminal body weight minus gravid uterine weight) were increase as liver to body weight ratio at highest dose when compare to control. - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Feed consumption was not affected during study.
- 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
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal Liver weight and postmortem body weights were recorded.
Slight increase in liver-to-body-weight ratio was observed in 1000 mg/kg/day concentrations. - Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- At uterotomy no adverse effects were observed number of corpora lutea, number of live fetuses per litter, litter size, mean fetal body weight, or mean crown-rump length. The pre- and postimplantation losses did not differ statistically between the control and the Quat-Silsesquioxane-treated groups.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No significant change were observed on clinical signs; mortality; body weight; food consumption
- Remarks on result:
- other: No toxic effect observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
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