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EC number: 477-700-1 | CAS number: 883794-93-2
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-10-10 to 2012-08-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 477-700-1
- EC Name:
- -
- Cas Number:
- 883794-93-2
- Molecular formula:
- Hill formula: C18H36N2O6S2Si2 CAS formula: C18H36N2O6S2Si2
- IUPAC Name:
- 1-{3-[(3-{2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecan-1-yl}propyl)disulfanyl]propyl}-2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecane
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: male: 138-157 g, female: 126-140
- Housing: individually in stainless steel cages
-Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.09-27.75
- Humidity (%): 39.9-61.44
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark
IN-LIFE DATES: From day of arrival, all surviving animals were sacrificed according to necropsy plan
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): common vehicle, test item is stable, well homogeneity and good suspension
- Concentration in vehicle: 0, 5, 20, 100 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg animal body weight - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Test article analysis of formulation was prepared with the same method as prepared for dosing animals. Validation study had been conducted to measure concentration, homogeneity and stability of test article suspended in corn oil. Formulations were sampled after stirring more than 5 min on the stir-plate. About 3-5 ml samples were taken randomly from the top, middle and the bottom of the liquids for each dosage (about 0.6-1ml each time was taken from each layer for at least 5 times together) while stirring. The samples were analysed with HPLC.
- Duration of treatment / exposure:
- The animals were dosed one time every morning for a period of 28 days (7days/week).
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 200, 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 animals each sex per group, 4 groups per dose
Additional 5 animals each sex were used in vehicle control group and in high dosage group for observation of reversibility, persistence, or delayed occurrence of toxic effects, for 14 days after dosing. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on LD50 of test item >2000 mg/kg bw and requirements of OECD guideline No. 407 (03 October 2008)
- animal selection randomly by software - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: every week
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: all animals 28 days, recovery groups for another 14 days.
- for morbidity and mortality daily, one time in the morning and one time in the afternoon
- general clinical observations: one time daily, 1 h after dosing, animal conditions and toxicity findings were recorded immediately
- detailed clinical observations: prior to the first exposure and once a week during treatment
BODY WEIGHT: Yes
- Time schedule for examinations: animals were weighed before grouping and once every week during the study. Animals were fasted overnight prior to necropsy and empty stomach body weights were collected before necropsy. When dosing was finished, all animals were weighed. Recovery animals were weighed the day before necropsy.
FOOD CONSUMPTION:
The food ration was added weekly (550g+-20g, including food box weight). The food and food boxes were weighed again 48 h (48h +-1.5h) later as surplus food weight. Mean food consumption for one animal per day was calculated.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: all surviving scheduled sacrificed animals at terminal necropsy
- Anaesthetic used for blood collection: Yes, CO2 (80% CO2 and 20% O2).
- Animals fasted: Yes / overnight
- How many animals: 60
- Parameters checked in table [No.1] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: all surviving scheduled sacrificed animals at terminal necropsy
- Anaesthetic used for blood collection: Yes, CO2 (80% CO2 and 20% O2).
- Animals fasted: Yes / overnight
- How many animals: 60
- Parameters checked in table [No.1] were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: in one week before necropsy, urine samples were collected from surviving animals by abdominal extrusion
- Parameters checked in table [No.1] were examined.
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: in the fourth exposure week
- Dose groups that were examined: animals in control group and high dose group
- Battery of functions tested: sensory activity / grip strength / motor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table 2), all survived animals of all dose groups (control, 50, 200, 1000 mg/kg bw, recovery groups)
HISTOPATHOLOGY: Yes (see table 2), all survived animals in control- and highest dose group (1000 mg/kg bw) after 28 days and all animals of control- and of high dose group after recovery period. Additionally, lung, kidney and liver of all survived animals of 50 and of 200 mg/kg dose group were examined. - Statistics:
- SPSS 17.0 software
Barlett test
Kruskal-Wallis non-parametric analyisis
Dunnett's test
ANOVA
Duncan's test
Mann-Whitney U -test
Fisher's exact test
Results and discussion
Results of examinations
- 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):
- not examined
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- During 28 days of treatment, there were no dead or moribund animals found, and no obvious test item-related signs of toxicity could be observed in both sexes at the administered dose levels. During clinical observations including functional examinations conducted at the end of the treatment no abnormalities were recorded. Normal body weight gain and food consumption in all groups were noted during the treatment period.
There were no test item-related changes seen in urinalysis, haematology and coagulation parameters.
Clinical chemistry examinations resulted in increased mean values for TP, ALB and TG in female animals dosed with 1000 mg/kg bw/day when compared with the control group. At the end of the recovery period, high dose females showed no increase of TP, ALB and TG. Therefore, these changes were considered as reversible. There were no test item-related macroscopic changes recorded for any of the tissues and organs removed during necropsy.
The absolute and relative organ weights of animals indicate that kidney and liver were affected.
Detailed analysis showed that absolute and relative kidney weights (organ to brain) of males in high dose and mid dose groups were significantly higher than those of the control group. At the end of the recovery period both absolute and relative kidney weights (organ to brain) of high dose males showed no statistically significant increase when compared with control. This indicates reversibility of these kidney weight changes.
Females showed only in high dose group weight changes of kidney and liver when compared with control. The absolute as well as the relative liver and kidney weights (organ to body and organ to brain) showed a statistically significant increase in high dose females (p<0.01). At the end of the recovery period increases of absolute and relative kidney weights (organ to brain) of lower statistically significance (p>0.05) were still present.
The results of histopathological examination showed kidney tubule hyperplasia in male and female animals (including recovery animals) of high dose group.
Fatty change of the liver and lung alveolar septum congestion were found in the control group and high dose group. Therefore, these changes were not related to the test substance.
No further significant histopathological changes of toxicological relevance were reported.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The NOAEL was determined based on the significant increase of kidney weight in high dose females at the end of the recovery period and the histopathological kidney changes in high dose males and femals.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the present study, obvious toxicity effects to kidneys of male and female SD rats were observed after repeated oral dosing for 28 days with the test substance at a dose of 1000 mg/kg bw/day. Absolute and relative kidney weights were increased in association with histopathological changes. Males showed also in the 200 mg/kg bw/day dose group statistically significant changes in kidney weights (absolute and relative), histopathological changes of kidneys were not significant in this group. At the end of the recovery period, statistically significant changes of kidney weights in high dose males were resolved. Therefore, these effects in males were considered to be reversible. Females showed only in the high dose group a statistically significant increase of kidney weights. At the end of the recovery period, this kidney weight increase was of lower statistical significance when compared with the end of the dosing period, which indicates reversibility of this toxicological effect. Based on the significant increase of kidney weight in high dose females at the end of the recovery period and the histopathological kidney changes in high dose males and females, the NOAEL (No Observed Adverse Effect Level) for the test substance in the rat was determined as follows: male: 200 mg/kg bw/day, female: 200 mg/kg bw/day.
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