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EC number: 219-786-3 | CAS number: 2530-86-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May - June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- N,N-dimethyl-3-(trimethoxysilyl)propylamine
- EC Number:
- 219-786-3
- EC Name:
- N,N-dimethyl-3-(trimethoxysilyl)propylamine
- Cas Number:
- 2530-86-1
- Molecular formula:
- C8H21NO3Si
- IUPAC Name:
- dimethyl[3-(trimethoxysilyl)propyl]amine
- Test material form:
- liquid
- Details on test material:
- - Name (as cited in the report): SAT 170001
- Chemical Name: N,N-dimethyl-3-(trimethoxysilyl)propylamine
- CAS No.: 2530-86-1
- Batch No.: 186020160504
- Aggregate State at RT: liquid
- Colour: colourless
- Storage Conditions: room temperature
- Expiry Date: 30.08.2017
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- ANIMALS
- Species/strain: WISTAR rats Crl: WI(Han)
- Source: Charles River, Germany
- Sex: female (non-pregnant, nulliparous)
- Number of animals: 3 per step
- Age at the beginning of the study: 8 - 10 weeks
- Body weight on the day of administration: Step 1: 142 – 155 g / Step 2: 154 – 166 g / Step 3: 178 – 197 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.
HOUSING & FEEDING
- 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 / 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
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 4 hours post dosing.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- The test item was administered at a single dose by gavage using a feeding tube.
The test item was administered at a dose volume of 10 mL/kg body weight. - Doses:
- 300 mg/kg bw, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- It is the principle of the acute toxic class method that, based on a stepwise procedure with the use of a minimum number of animals per step, sufficient information is obtained on the acute toxicity of the test item to enable its classification. The item is tested using a stepwise procedure with up to four fixed doses. Absence or presence of compound-related mortality of the animals dosed at one step will determine the next step.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- < 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off
- Mortality:
- No mortality
- Clinical signs:
- other: The test item showed acute oral toxicity characteristics after a single dose administration at a dosage of 2000 mg/kg bw.
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
CLINICAL SIGNS PER STEP
STEP 1: 300 mg/kg bw, 3 females
0 min - 15 d | nsf |
STEP 2: 2000 mg/kg bw, 3 females
0 - 30 min | nsf |
30 - 180 min | Slightly reduced spontaneous activity |
180 min - 2 d | nsf |
2 d - 3 d | Slight piloerection (1/3 rats) |
3 d - 15 d | nsf |
STEP 3: 2000 mg/kg bw, 3 females
0 - 30 min | Slightly reduced spontaneous activity, hunched posture, slight piloerection, half eyelid closure (2/3 rats), prone position (1/3 rats) |
30 - 60 min | Moderately reduced spontaneous activity, hunched posture, slight piloerection, half eyelid closure |
60 - 120 min | Slightly reduced spontaneous activity, half eyelid closure |
120 - 180 min | Slightly reduced spontaneous activity, slight piloerection |
180 - 240 min | Slightly reduced spontaneous activity |
240 min - 15 d | nsf |
LD50 CUT-OFF
Dose [mg/kg bw] | No. of animals | No. of intercurrent deaths | LD50 Cut-Off |
300 | 3 | 0 | 5000 mg/kg bw |
2000 | 6 | 0 |
nsf: no specific findings
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- 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 not associated with signs of toxicity or mortality.
Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but not with mortality. The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 5000 mg/ kg bw.
According to Annex I of Regulation (EC) 1272/2008 the test item has no obligatory labelling requirement for toxicity and is not classified.
According to GHS (Globally Harmonized Classification System) the test item has no obligatory labelling requirement for toxicity and is classified into Category 5. - 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 dissolved in olive oil at a concentration of 0.03 g/mL and administered at a dose volume of 10 mL/kg.
Two groups, 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 dissolved in olive oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study 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.
RESULTS
All animals treated with the test item at a dose of 300 mg/kg bw (step 1) survived until the end of the study without showing signs of toxicity.
All animals treated with the test item at a dose of 2000 mg/kg bw (step 2 and 3) 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 2000 mg/kg bw were reduced spontaneous activity, piloerection, half eyelid-closure, hunched posture and prone position. All symptoms recovered within up to 2 days post-dose.
Throughout the 14-day observation period, the weight gain of all animals was within the normal range of variation for this strain.
At necropsy, no macroscopic findings were observed in any animal of any step.
CONCLUSION
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 not associated with signs of toxicity or mortality.
Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but not with mortality. The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 5000 mg/ kg bw.
According to Annex I of Regulation (EC) 1272/2008 the test item has no obligatory labelling requirement for toxicity and is not classified.
According to GHS (Globally Harmonized Classification System) the test item has no obligatory labelling requirement for toxicity and is classified into Category 5.
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