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EC number: 813-152-5 | CAS number: 152261-44-4
- 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
REACH_LD50 > 2000 mg/kg bw | rat (male/female) | OECD 423 | #key study#
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February - March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: WISTAR Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- ANIMALS
- Species/strain: WISTAR rats Crl: WI(Han)
- Source: Charles River, Sulzfeld, Germany
- Sex: Female (non-pregnant and nulliparous)
- Number of animals: 3 per step
- Age at the beginning of the study: 10–12 weeks
- Body weight on the day of administration:Step 1: 182–209 g; Step 2: 204–232 g; Step 3: 210–233 g
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to the German Act on Animal Welfare the animals were bred for experimental
purposes. This study was performed in an AAALAC-accredited laboratory. According to German animal protection law, the study type has been reviewed and accepted by local authorities. Furthermore, the study has been subjected to Ethical Review Process and was authorised by the Bavarian animal welfare administration.
The animals were marked for individual identification by tail painting.
Prior to the administration a detailed clinical observation was made of all animals. Only healthy animals were used.
Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 3 to 4 hours post (last) dosing.
HOUSING
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x 1 hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Adequate acclimatisation period (at least five days) under laboratory conditions - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test item was administered at a dose volume of 10 mL/kg body weight.
At dose level of 300 mg/kg body weight (step 1) the test item was administered at a single dose by gavage using a feeding tube.
At a dose level of 2000 mg/kg body weight the test item was administered in smaller fractions over a period of maximum 24 hours according to OECD Guideline 423.
The test item was administered by gavage using a feeding tube. Two separate administrations (1000 mg/kg body weight each time) were performed for steps 2 and 3, both at an interval of 3 hours. - Doses:
- 300 mg/kg bw, 2000 mg/kg bw
- No. of animals per sex per dose:
- Step 1: 3
Step 2: 3
Step 3: 3 - Control animals:
- no
- Details on study design:
- One group, of three female WISTAR Crl: WI(Han) rats, was treated with the test item by oral gavage administration at a dosage of 300 mg/kg body weight. The test item was emulsified with the vehicle corn oil at a concentration of 0.1039 g/mL and administered at a dose volume of 10 mL/kg.
A second and third group, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight The test item was emulsified with the vehicle corn oil at a concentration of 0.6896 g/mL and administered in two doses of 1000 mg/kg bw at dose volume of 10 mL/kg in an interval of 3 hours.
All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item showed no mortality and but other acute oral toxicity characteristics after a single dose administration.
- Clinical signs:
- The test item showed acute oral toxicity characteristics after a single dose administration.
- Body weight:
- None of the animals showed weight loss during the observation period.
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The median lethal dose of Ethanol, 2,2’-[1,2-ethanediylbis(oxy)] bis-, reaction products with 3-(triethoxysilyl)-1-propanamine after a single or double oral administration to female rats, observed over a period of 14 days is: LD50cut-off (rat): 5000mg/ kg bw.
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection, hunched posture, ataxia and half eyelid-closure. All animals recovered within up to 2 days post-dose. - Executive summary:
One group, of three female WISTAR Crl: WI(Han) rats, was treated with the test item by oral gavage administration at a dosage of 300 mg/kg body weight. The test item was emulsified with the vehicle corn oil at a concentration of 0.1039 g/mL and administered at a dose volume of 10 mL/kg.
A second and third group, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight The test item was emulsified with the vehicle corn oil at a concentration of 0.6896 g/mL and administered in two doses of 1000 mg/kg bw at dose volume of 10 mL/kg in an interval of 3 hours.
All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study showing signs of toxicity.
The most relevant clinical findings in the animals treated with the test item at a dose of 300 mg/kg bw were reduced spontaneous activity, piloerection, and hunched posture. All animals recovered within up to 2 days post-dose.
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection, hunched posture, ataxia and half eyelid-closure. All animals recovered within up to 2 days post-dose.
Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain.
At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
LD50cut-off (rat): 5000mg/kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle: Corn oil
Number of animals: 3 per step / 2 steps performed
Conclusion
Under the conditions of the present study, a single oral application of the test item Ethanol, 2,2’-[1,2-ethanediylbis(oxy)] bis-, reaction products with 3-(triethoxysilyl)-1-propanamine to rats at a dose of 300 mg/kg body weight was associated with signs of toxicity but not with mortality.
Under the conditions of the present study, a double oral application of the test item Ethanol, 2,2’-[1,2-ethanediylbis(oxy)] bis-, reaction products with 3-(triethoxysilyl)-1-propanamine to rats at a dose of 1000 mg/kg body weight (i.e. 2000 mg/kg body weight in total) at an interval of 3 hours was associated with signs of toxicity but not with mortality.
The median lethal dose of Ethanol, 2,2’-[1,2-ethanediylbis(oxy)] bis-, reaction products with 3-(triethoxysilyl)-1-propanamine after a single or double oral administration to female rats, observed over a period of 14 days is:
LD50cut-off (rat):5000mg/ kg bw
Reference
Under the conditions of the present study, a single oral application of the test item to rats at a dose of 300 mg/kg body weight was associated with signs of toxicity but not with mortality.
Under the conditions of the present study, a double oral application of the test item to rats at a dose of 1000 mg/kg body weight (i.e. 2000 mg/kg body weight in total) at an interval of 3 hours was associated with signs of toxicity but not with mortality.
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection, hunched posture, ataxia and half eyelid-closure. All animals recovered within up to 2 days post-dose.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In a GLP study according to OECD guideline 423, a double oral application of the test item Ethanol, 2,2’-[1,2-ethanediylbis(oxy)] bis-, reaction products with 3-(triethoxysilyl)-1-propanamine to rats at a dose of 1000 mg/kg body weight (i.e. 2000 mg/kg body weight in total) at an interval of 3 hours was associated with signs of toxicity but not with mortality.
The median lethal dose of Ethanol, 2,2’-[1,2-ethanediylbis(oxy)] bis-, reaction products with 3-(triethoxysilyl)-1-propanamine after a single or double oral administration to female rats, observed over a period of 14 days is:
LD50cut-off (rat): 5000 mg/kg bw
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