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EC number: 274-936-5 | CAS number: 70851-50-2
- 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
Endpoint summary
Administrative data
Description of key information
Oral (OECD 423), 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:
- 13 May - 12 Sep 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns SozialesFreie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany
- 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: 42 (males) or 53 (females) days
- Weight at study initiation: 215 - 230 g (males); 206 - 231 g (females)
- Fasting period before study: yes (16 h before administration)
- Housing: 2-3 animals per cage during the 14-day observation period (MAKROLON cages, type III).
- Diet: ssniff/R/M-H V 1530 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 May 2002 To : 02 Jul 2002 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.35 ml/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- First step: 3 males
Second step: 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, at 5, 15, 30 and 60 min, as well as at 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days (once daily). Body weight was determined before administration and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Changes of skin and fur, eyes and mucous membranes, respiratory and circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern were observed at least once daily until all symptoms subsided (afterwards each working day). - Statistics:
- No statistical analysis was performed
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- No clinical signs of toxicity were observed.
- Body weight:
- All surviving animals gained the expected body weight.
- Gross pathology:
- No abnormalities were observed.
- 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 conducted according to OECD 423 and in compliance with GLP, a LD50 >2000 mg/kg bw was observed in rats. No mortality and no clinical signs were observed. No effects on body weight gain and no abnormalities at necropsy were reported.
Reference
Table 1: Body weights, body weight gain and autopsy findings of the surviving rats.
Body weights (body weight gain) [g] |
Dose, oral gavage: 2000 mg/kg bw |
|
|
male |
female |
start |
225.0 |
216.3 |
after 7 days |
283.0 (+25.7) |
240.3 (+11.1) |
after 14 days |
308.3 (+37.0) |
249.3 (+15.3) |
Inhibition of body weight gain |
none |
none |
Autopsy finding |
none |
none |
Mortality |
0/3 |
0/3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.6, 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
A key study is available with dimethoxymethyloctadecylsilane (CAS 70851-50-2), which was conducted according to OECD 423 and in compliance with GLP (LPT, 2002). In a first step 3 male Crl:CD rats were treated with the limit dose of 2000 mg/kg bw. No mortality and no clinical signs were observed. In accordance with the testing strategy supplied in OECD guideline 423, 3 female animals were treated with the limit dose of 2000 mg/kg bw. Again, no mortality and no clinical signs were observed. No findings after necropsy and no effects on body weight were observed in any animal. In conclusion, a LD50 >2000 mg/kg bw was derived for dimethoxymethyloctadecylsilane after oral treatment.
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 according to Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
No data on acute dermal and inhalation 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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