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EC number: 277-551-0 | CAS number: 73609-36-6
- 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
The key acute oral toxicity study, which was conducted according to OECD Test Guideline 423 and in compliance with GLP, the concluded LD50 value was between 200 and 2000 mg/kg bw (LPT, 2002a).
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:
- May 3rd 2002 to June 10th 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:
- yes
- Remarks:
- dose levels differ from guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- dose levels differ from guideline
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633.
- Age at study initiation: male 41 days, female 48 days.
- Weight at study initiation: male (6 animals) 173-213 g; female (3 animals) 167-178 g.
- Fasting period before study: 16 hours before administration.
- Housing: Makrolon cages (type 3), 2-3 animals per cage. Granulated textured wood (Granulate A2, J. Brandenburg, D49424 Goldenstedt) was used as bedding material.
- Diet ssniff R/M-H V 1530 ad libitum.
- Water: drinking water ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: April 2002 To: June 10th 2002 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: undiluted for highest dose; 10% for second dose level.
MAXIMUM DOSE VOLUME APPLIED: 1.29 ml/kg bw.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: none given in report. The dose used is the limit dose for EU acute oral classification. - Doses:
- 200, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 male rats (2000 mg/kg bw); 3 male and 3 female (200 mg/kg bw).
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made before and immediately, at 5, 15, 30 and 60 minutes, then at 3, 6 and 24 hours after administration. All surviving animals were examined at daily intervals. Weights were recorded on days 0, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and macroscopic inspection of all animals that died prematurely; macroscopic examination of all survivors for gross pathological changes was carried out, and microscopic examination of all organs which showed evident lesions would have been performed. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The three male animals dosed with 2000 mg/kg bw died within 30 minutes. None of the 3 male and 3 female animals dosed with 200 mg/kg bw died.
- Clinical signs:
- other: 2000 mg/kg bw resulted in the following signs of systemic toxicity; reduced motility, ataxia, reduced muscle tone, dyspnoea. None of the 3 male and 3 female animals dosed with 200 mg/kg bw showed signs of systemic toxicity.
- Gross pathology:
- No abnormalities were found on macroscopic post mortem examination of the animals.
- Other findings:
- No effect dose level: 200 mg/kg bw.
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Toxicity Category IV by application of Regulation (EC) No 1272/2008
- Conclusions:
- [2-(Perfluorohexyl)ethyl]dichloro(methyl)silane has been tested for acute oral toxicity in an acute toxic class study conducted according to OECD 423 and in compliance with GLP. All of three male CD rats dosed with 2000 mg/kg bw of test substance died within 6 hours. The clinical signs observed in these animals were reduced motility, ataxia, reduced muscle tone and dyspnoea; there were no gross abnormalities observed on necropsy. There were no clinical signs, deaths or macroscopic abnormalities found in the three male and three female animals treated with 200 mg/kg bw. It was concluded that the LD₅₀ is between 200 and 2000 mg/kg bw. [2-(Perfluorohexyl)ethyl]dichloro(methyl)silane is hydrolytically unstable, with a hydrolysis half-life at 37.5ºC and pH 4 (relevant for conditions in the stomach following oral exposure), of approximately 5 seconds (predicted). Therefore it is considered that the animals would have been exposed to the hydrolysis products, [2-(perfluorohexyl)ethyl]methylsilanediol and hydrochloric acid, and that the effects observed reflect the properties of the hydrolysis products.
Reference
Summary of results of acute toxicity study
Symptoms/criteria |
2000 mg/kg bw |
200 mg/kg bw |
||
male (n=3) |
male (n=3) |
female (n=3) |
||
Reduced motility |
++ to +++ 5 – 15 minutes |
- |
- |
|
Ataxia |
++ to +++ 5 – 15 minutes |
- |
- |
|
Reduced muscle tonus |
+ to ++ 5 – 15 minutes |
- |
- |
|
Dyspnoea |
++ to +++ 5 – 15 minutes |
- |
- |
|
Mortality |
within 6 hours |
3 |
0 |
0 |
within 14 days |
3 |
0 |
0 |
|
Mean weight |
Day 0 |
204.7 g |
181.7 g |
173.7 g |
Day 8 |
- |
232.0 g |
205.7 g |
|
Day 15 |
- |
236.0 g |
216.7 g |
|
Inhibition of body weight gain |
None |
None |
None |
|
Autopsy findings |
None |
None |
None |
+ slight
++ moderate
+++ severe
- not observed
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 200 mg/kg bw
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 oral test data are available for [2-(perfluorohexyl)ethyl]dichloro(methyl)silane, although no testing for this endpoint is required for compliance with REACH as the substance is corrosive. An acute toxicity study was already available for the substance and this is included in the dossier for completeness.
[2-(Perfluorohexyl)ethyl]dichloro(methyl)silane has been tested for acute oral toxicity in an acute toxic class study conducted according to OECD 423 and in compliance with GLP (LPT, 2002a). All of three male CD rats dosed with 2000 mg/kg bw of test substance died within 6 hours. The clinical signs observed in these animals were reduced motility, ataxia, reduced muscle tone and dyspnoea; there were no gross abnormalities observed on necropsy. There were no clinical signs, deaths or macroscopic abnormalities found in the three male and three female animals treated with 200 mg/kg bw. It was concluded that the LD₅₀ is between 200 and 2000 mg/kg bw.
[2-(Perfluorohexyl)ethyl]dichloro(methyl)silane is hydrolytically unstable, with a hydrolysis half-life at 37.5ºC and pH 2 (relevant for conditions in the stomach following oral exposure), of approximately 5 seconds (predicted). Therefore it is considered that the animals would have been exposed to the hydrolysis products, [2-(perfluorohexyl)ethyl]methylsilanediol and hydrochloric acid, and that the effects observed reflect the properties of the hydrolysis products.
Justification for classification or non-classification
Based on the available data, [2-(perfluorohexyl)ethyl]dichloro(methyl)silane requires a Category 4 classification for acute oral toxicity, H302: 'Harmful if swallowed', according to Regulation (EC) No 1272/2008.
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