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EC number: 221-334-5 | CAS number: 3069-25-8
- 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
Oral (OECD 401), rat: LD50 >2000 mg/kg bw
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:
- 09 - 23 Oct 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study conducted according to the appropriate OECD test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Bor: WISW
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: approx. 162 g
- Fasting period before study: Animals were fasted overnight (16 h) prior to dosing.
- Housing: Animals were housed in groups of 1 - 5 in Makrolon cages (type III).
- Diet: R10 diet for rats (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.11 ml/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed prior to dosing and 1, 7 and 14 days thereafter. Furthermore, animals were observed for clinical signs of toxicity up to 6 h after administration of the test material and daily thereafter.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred throughout the study period.
- Clinical signs:
- All animals showed staggering movements, piloerection, hunched posture, bloody noses (partially), mild sedation and ataxia as well as dyspnea five to ten minutes after test material administration. All clinical signs were reversible within 48 h post-administration of the test material.
- Body weight:
- With the exception of one animal the remaining 9/10 animals showed expected gains in body weight during the study period.
- Gross pathology:
- Necropsy revealed partially hyperaemia of the mucous membrane of the small intestine in 2/5 females. Additionally, partially peritoneal hyperaemia and a narrowed spleen was observed in 1/5 males. All other animals did not show any abnormalities at necropsy.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In an acute oral toxicity study according to OECD guideline 401, no mortality and no signs of systemic toxicity were observed at 2000 mg/kg bw. In conclusion, a LD50 >2000 mg/kg bw was derived.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
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
Acute toxicity: oral
An acute oral toxicity study is available for the registered substance N-methyl-3-(trimethoxysilyl)propylamine (CAS 3069-25-8) which was conducted according to OECD 401 (Hüls AG, 1989a). In this limit test five fasted Bor:WISW rats of each sex were administered a single dose of 2000 mg/kg bw of the test substance via oral gavage. The animals were observed for 14 days after administration. No mortalities occurred during the entire study period. All animals showed clinical signs such as staggering movements, piloerection, hunched posture, bloody noses (partially), mild sedation and ataxia as well as dyspnea five to ten minutes after test material administration. All clinical signs were reversible within 48 h post-administration of the test material. With the exception of one animal the remaining 9/10 animals showed expected gains in body weight during the study period. Necropsy revealed partially hyperaemia of the mucous membrane of the small intestine in 2/5 females. Additionally, partially peritoneal hyperaemia and a narrowed spleen was observed in 1/5 males. All other animals did not show any abnormalities at necropsy. Thus, the acute oral LD50 value for males/females was calculated to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
The available data on acute oral toxicity of the registered substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
No data on acute inhalation or dermal toxicity are available.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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