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EC number: 240-464-3 | CAS number: 16415-12-6
- 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
Acute oral toxicity (OECD TG 423, GLP): LD50>2000 mg/kg bw
Acute inhalation toxicity: data waiver according to Column 2 of REACH Annex VIII
Acute dermal toxicity: data waiver according to Column 2 of REACH Annex VIII
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:
- 15 April 2002 to 16 May 2002
- 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)
- Version / remarks:
- (adopted 2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, GERMANY
- Age at study initiation: 41 days (m); 49 days (f)
- Weight at study initiation: 210-211 g (m); 185-199 g (f)
- Fasting period before study: 16 h
- Housing: 2-3/Makrolon cage (type III)
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
none
MAXIMUM DOSE VOLUME APPLIED: 2.25 ml/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: none identified within report, but follows guideline which recommends a starting dose of 2000 mg/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations 5, 15, 30, 60 mins; 3, 6, 24 h; then daily for 14 days. Weighings weekly.
- Necropsy of survivors performed: yes - Statistics:
- None.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed throughout the study period.
- Clinical signs:
- other: No clinical signs were observed in the animals during the study.
- Gross pathology:
- No significant findings.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- A reliable study (reliability score 1) conducted according to the standard guideline for the Acute Toxic Class method and in compliance with GLP found the LD50 in rats to be in excess of 2000 mg/kg bw. There were no clinical signs of toxicity, effects on body weight or macroscopic findings.
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
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: oral
In the key acute oral toxicity study (LPT, 2002a), conducted according to OECD TG 423 (Acute Toxic Class Method) and in compliance with GLP, undiluted hexadecyl(trimethoxy)silane (CAS 16415-12-6) was administered via gavage to 3 Crl:CD rats per sex at a dose of 2000 mg/kg bw. No deaths occurred and no clinical signs were observed throughout the study period. Among this, no treatment-related effects on body weight were noted. Gross pathology revealed no significant findings. The LD50 was therefore set at > 2000 mg/kg bw.
These results were supported by an acute oral toxicity study, conducted according to OECD TG 401 and in compliance with GLP (Asta Pharma AG, 1989a). The oral gavage administration of the registered substance at a dose 5002 mg/kg bw to 5 Bor:WISW (SPFCpb) rats of each sex did not result in deaths. No clinical signs and no treatment-related effects on body weight or abnormalities on gross macroscopic examination were observed. Thus, a LD50 > 5002 mg/kg bw was deduced.
Acute toxicity: inhalation
No data available.
Acute toxicity: dermal
The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (skin irritation and skin sensitisation).
As supporting information, available acute dermal toxicity data from the source substance trimethoxy(octadecyl)silane (CAS 3069-42-9) was considered in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across”.
Trimethoxy(octadecyl)silane (CAS 3069-42-9)
was investigated for acute dermal toxicity in a limit test conducted
according to the OECD TG 402, and in compliance with GLP (Degussa AG,
1987). 2000 mg/kg bw of the undiluted test material were occlusively
applied to the shoulder of 3 White Russian rabbits per sex. Following 24
h of exposure, the test material was washed off with water. No deaths
occurred throughout the study period, and no clinical signs except for
local effects (described as erythema on the test site immediately after
treatment and desquamation on days 3 -7 days of the observation period)
were observed. All effects were fully reversible within 13 days. Among
this, no effects on body weight gain and no abnormal pathological
findings were reported. Based on this data, the LD50 for acute dermal
toxicity of trimethoxy(octadecyl)silane (CAS 3069-42-9) was set at >
2000 mg/kg bw.
Justification for classification or non-classification
The available data is reliable and suitable for classification. Based on this data, classification for acute toxicity according to Regulation (EC) No. 1272/2008 is not warranted.
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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