Registration Dossier
Registration Dossier
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EC number: 248-595-8 | CAS number: 27668-52-6
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from NTRL report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of Dow Corning Q9-5700
- 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:
- dimethyl(octadecyl)[3-(trimethoxysilyl)propyl]azanium chloride
- Reference substance name:
- Quaternary Silsesquioxane
- IUPAC Name:
- Quaternary Silsesquioxane
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report):Quaternary Silsesquioxane
- Molecular formula (if other than submission substance):C26H58CL1N1O3Si1
- Molecular weight (if other than submission substance):496.30g/mol
- Substance type:Organic
- Physical state:Liquid
Constituent 1
Constituent 2
- 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
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on species / strain selection:
- No data
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on exposure:
- TEST SITE
- Area of exposure: Shaved back and abdomen
- % coverage: 60 sq. inches
- Type of wrap if used: Fabric
- Time intervals for shavings or clipplings: No data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: After 6 hrs contact period
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): 0, 0.5% or 5.0% w/w
- Constant volume or concentration used: No data
- For solids, paste formed: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data
USE OF RESTRAINERS FOR PREVENTING INGESTION: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- 6 hrs/day, 5 days/week
Doses / concentrations
- Remarks:
- 0, 0.5% or 5.0% w/w (0, 151.5 or 1515.15 mg/Kg bw/day)
- No. of animals per sex per dose:
- No data
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. Mortality
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: No data
BODY WEIGHT: Yes
- Time schedule for examinations: No data
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
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
WATER CONSUMPTION: No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: Yes
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- 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):
- not specified
- 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:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality
Mortality: No significant untoward alterations were observed with regards to mortality
Clinical signs: No data
Dermal irritation: No significant untoward alterations were observed with regards to dermal reactions
Body weight and weight gain: No significant untoward effects were observed on body weight
Food consumption and compound intake: No data
Food efficiency: No data
Water consumption and compound intake: No data
Opthalmoscopic examination: No data
Haematology: No significant untoward alterations were observed with regards to hematologic parameters
Clinical chemistry: No significant untoward alterations were observed with regards to clinical chemistry parameters
Urinanalysis: No significant untoward alterations were observed with regards to urine analysis
Neurobehaviour: No data
Organ weights: No data
Gross pathology: No significant untoward alterations were observed with regards to gross pathology
Histopathology: No significant untoward alterations were observed with regards to microscopic pathologic examinations
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 515.15 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No significant untoward alterations observed
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect level (NOAEL) for Dow Corning Q9-5700 is found to be 5.0 % w/w (1515.15 mg/Kg bw/day) when applied to shaved back and abdomen of rabbits.
- Executive summary:
Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of Dow Corning Q9-5700. 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) forDow Corning Q9-5700 is found to be 5.0 % w/w (1515.15 mg/Kg bw/day) when applied to shaved back and abdomen of rabbits.
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